Background: #fff
Foreground: #000
PrimaryPale: #8cf
PrimaryLight: #18f
PrimaryMid: #04b
PrimaryDark: #014
SecondaryPale: #ffc
SecondaryLight: #fe8
SecondaryMid: #db4
SecondaryDark: #841
TertiaryPale: #eee
TertiaryLight: #ccc
TertiaryMid: #999
TertiaryDark: #666
Error: #f88
<!--{{{-->
<div class='toolbar' macro='toolbar [[ToolbarCommands::EditToolbar]]'></div>
<div class='title' macro='view title'></div>
<div class='editor' macro='edit title'></div>
<div macro='annotations'></div>
<div class='editor' macro='edit text'></div>
<div class='editor' macro='edit tags'></div><div class='editorFooter'><span macro='message views.editor.tagPrompt'></span><span macro='tagChooser excludeLists'></span></div>
<!--}}}-->
To get started with this blank [[TiddlyWiki]], you'll need to modify the following tiddlers:
* [[SiteTitle]] & [[SiteSubtitle]]: The title and subtitle of the site, as shown above (after saving, they will also appear in the browser title bar)
* [[MainMenu]]: The menu (usually on the left)
* [[DefaultTiddlers]]: Contains the names of the tiddlers that you want to appear when the TiddlyWiki is opened
You'll also need to enter your username for signing your edits: <<option txtUserName>>
<<importTiddlers>>
<!--{{{-->
<link rel='alternate' type='application/rss+xml' title='RSS' href='index.xml' />
<!--}}}-->
These [[InterfaceOptions]] for customising [[TiddlyWiki]] are saved in your browser

Your username for signing your edits. Write it as a [[WikiWord]] (eg [[JoeBloggs]])

<<option txtUserName>>
<<option chkSaveBackups>> [[SaveBackups]]
<<option chkAutoSave>> [[AutoSave]]
<<option chkRegExpSearch>> [[RegExpSearch]]
<<option chkCaseSensitiveSearch>> [[CaseSensitiveSearch]]
<<option chkAnimate>> [[EnableAnimations]]

----
Also see [[AdvancedOptions]]
<!--{{{-->
<div class='header' role='banner' macro='gradient vert [[ColorPalette::PrimaryLight]] [[ColorPalette::PrimaryMid]]'>
<div class='headerShadow'>
<span class='siteTitle' refresh='content' tiddler='SiteTitle'></span>&nbsp;
<span class='siteSubtitle' refresh='content' tiddler='SiteSubtitle'></span>
</div>
<div class='headerForeground'>
<span class='siteTitle' refresh='content' tiddler='SiteTitle'></span>&nbsp;
<span class='siteSubtitle' refresh='content' tiddler='SiteSubtitle'></span>
</div>
</div>
<div id='mainMenu' role='navigation' refresh='content' tiddler='MainMenu'></div>
<div id='sidebar'>
<div id='sidebarOptions' role='navigation' refresh='content' tiddler='SideBarOptions'></div>
<div id='sidebarTabs' role='complementary' refresh='content' force='true' tiddler='SideBarTabs'></div>
</div>
<div id='displayArea' role='main'>
<div id='messageArea'></div>
<div id='tiddlerDisplay'></div>
</div>
<!--}}}-->
/*{{{*/
body {background:[[ColorPalette::Background]]; color:[[ColorPalette::Foreground]];}

a {color:[[ColorPalette::PrimaryMid]];}
a:hover {background-color:[[ColorPalette::PrimaryMid]]; color:[[ColorPalette::Background]];}
a img {border:0;}

h1,h2,h3,h4,h5,h6 {color:[[ColorPalette::SecondaryDark]]; background:transparent;}
h1 {border-bottom:2px solid [[ColorPalette::TertiaryLight]];}
h2,h3 {border-bottom:1px solid [[ColorPalette::TertiaryLight]];}

.button {color:[[ColorPalette::PrimaryDark]]; border:1px solid [[ColorPalette::Background]];}
.button:hover {color:[[ColorPalette::PrimaryDark]]; background:[[ColorPalette::SecondaryLight]]; border-color:[[ColorPalette::SecondaryMid]];}
.button:active {color:[[ColorPalette::Background]]; background:[[ColorPalette::SecondaryMid]]; border:1px solid [[ColorPalette::SecondaryDark]];}

.header {background:[[ColorPalette::PrimaryMid]];}
.headerShadow {color:[[ColorPalette::Foreground]];}
.headerShadow a {font-weight:normal; color:[[ColorPalette::Foreground]];}
.headerForeground {color:[[ColorPalette::Background]];}
.headerForeground a {font-weight:normal; color:[[ColorPalette::PrimaryPale]];}

.tabSelected {color:[[ColorPalette::PrimaryDark]];
	background:[[ColorPalette::TertiaryPale]];
	border-left:1px solid [[ColorPalette::TertiaryLight]];
	border-top:1px solid [[ColorPalette::TertiaryLight]];
	border-right:1px solid [[ColorPalette::TertiaryLight]];
}
.tabUnselected {color:[[ColorPalette::Background]]; background:[[ColorPalette::TertiaryMid]];}
.tabContents {color:[[ColorPalette::PrimaryDark]]; background:[[ColorPalette::TertiaryPale]]; border:1px solid [[ColorPalette::TertiaryLight]];}
.tabContents .button {border:0;}

#sidebar {}
#sidebarOptions input {border:1px solid [[ColorPalette::PrimaryMid]];}
#sidebarOptions .sliderPanel {background:[[ColorPalette::PrimaryPale]];}
#sidebarOptions .sliderPanel a {border:none;color:[[ColorPalette::PrimaryMid]];}
#sidebarOptions .sliderPanel a:hover {color:[[ColorPalette::Background]]; background:[[ColorPalette::PrimaryMid]];}
#sidebarOptions .sliderPanel a:active {color:[[ColorPalette::PrimaryMid]]; background:[[ColorPalette::Background]];}

.wizard {background:[[ColorPalette::PrimaryPale]]; border:1px solid [[ColorPalette::PrimaryMid]];}
.wizard h1 {color:[[ColorPalette::PrimaryDark]]; border:none;}
.wizard h2 {color:[[ColorPalette::Foreground]]; border:none;}
.wizardStep {background:[[ColorPalette::Background]]; color:[[ColorPalette::Foreground]];
	border:1px solid [[ColorPalette::PrimaryMid]];}
.wizardStep.wizardStepDone {background:[[ColorPalette::TertiaryLight]];}
.wizardFooter {background:[[ColorPalette::PrimaryPale]];}
.wizardFooter .status {background:[[ColorPalette::PrimaryDark]]; color:[[ColorPalette::Background]];}
.wizard .button {color:[[ColorPalette::Foreground]]; background:[[ColorPalette::SecondaryLight]]; border: 1px solid;
	border-color:[[ColorPalette::SecondaryPale]] [[ColorPalette::SecondaryDark]] [[ColorPalette::SecondaryDark]] [[ColorPalette::SecondaryPale]];}
.wizard .button:hover {color:[[ColorPalette::Foreground]]; background:[[ColorPalette::Background]];}
.wizard .button:active {color:[[ColorPalette::Background]]; background:[[ColorPalette::Foreground]]; border: 1px solid;
	border-color:[[ColorPalette::PrimaryDark]] [[ColorPalette::PrimaryPale]] [[ColorPalette::PrimaryPale]] [[ColorPalette::PrimaryDark]];}

.wizard .notChanged {background:transparent;}
.wizard .changedLocally {background:#80ff80;}
.wizard .changedServer {background:#8080ff;}
.wizard .changedBoth {background:#ff8080;}
.wizard .notFound {background:#ffff80;}
.wizard .putToServer {background:#ff80ff;}
.wizard .gotFromServer {background:#80ffff;}

#messageArea {border:1px solid [[ColorPalette::SecondaryMid]]; background:[[ColorPalette::SecondaryLight]]; color:[[ColorPalette::Foreground]];}
#messageArea .button {color:[[ColorPalette::PrimaryMid]]; background:[[ColorPalette::SecondaryPale]]; border:none;}

.popupTiddler {background:[[ColorPalette::TertiaryPale]]; border:2px solid [[ColorPalette::TertiaryMid]];}

.popup {background:[[ColorPalette::TertiaryPale]]; color:[[ColorPalette::TertiaryDark]]; border-left:1px solid [[ColorPalette::TertiaryMid]]; border-top:1px solid [[ColorPalette::TertiaryMid]]; border-right:2px solid [[ColorPalette::TertiaryDark]]; border-bottom:2px solid [[ColorPalette::TertiaryDark]];}
.popup hr {color:[[ColorPalette::PrimaryDark]]; background:[[ColorPalette::PrimaryDark]]; border-bottom:1px;}
.popup li.disabled {color:[[ColorPalette::TertiaryMid]];}
.popup li a, .popup li a:visited {color:[[ColorPalette::Foreground]]; border: none;}
.popup li a:hover {background:[[ColorPalette::SecondaryLight]]; color:[[ColorPalette::Foreground]]; border: none;}
.popup li a:active {background:[[ColorPalette::SecondaryPale]]; color:[[ColorPalette::Foreground]]; border: none;}
.popupHighlight {background:[[ColorPalette::Background]]; color:[[ColorPalette::Foreground]];}
.listBreak div {border-bottom:1px solid [[ColorPalette::TertiaryDark]];}

.tiddler .defaultCommand {font-weight:bold;}

.shadow .title {color:[[ColorPalette::TertiaryDark]];}

.title {color:[[ColorPalette::SecondaryDark]];}
.subtitle {color:[[ColorPalette::TertiaryDark]];}

.toolbar {color:[[ColorPalette::PrimaryMid]];}
.toolbar a {color:[[ColorPalette::TertiaryLight]];}
.selected .toolbar a {color:[[ColorPalette::TertiaryMid]];}
.selected .toolbar a:hover {color:[[ColorPalette::Foreground]];}

.tagging, .tagged {border:1px solid [[ColorPalette::TertiaryPale]]; background-color:[[ColorPalette::TertiaryPale]];}
.selected .tagging, .selected .tagged {background-color:[[ColorPalette::TertiaryLight]]; border:1px solid [[ColorPalette::TertiaryMid]];}
.tagging .listTitle, .tagged .listTitle {color:[[ColorPalette::PrimaryDark]];}
.tagging .button, .tagged .button {border:none;}

.footer {color:[[ColorPalette::TertiaryLight]];}
.selected .footer {color:[[ColorPalette::TertiaryMid]];}

.error, .errorButton {color:[[ColorPalette::Foreground]]; background:[[ColorPalette::Error]];}
.warning {color:[[ColorPalette::Foreground]]; background:[[ColorPalette::SecondaryPale]];}
.lowlight {background:[[ColorPalette::TertiaryLight]];}

.zoomer {background:none; color:[[ColorPalette::TertiaryMid]]; border:3px solid [[ColorPalette::TertiaryMid]];}

.imageLink, #displayArea .imageLink {background:transparent;}

.annotation {background:[[ColorPalette::SecondaryLight]]; color:[[ColorPalette::Foreground]]; border:2px solid [[ColorPalette::SecondaryMid]];}

.viewer .listTitle {list-style-type:none; margin-left:-2em;}
.viewer .button {border:1px solid [[ColorPalette::SecondaryMid]];}
.viewer blockquote {border-left:3px solid [[ColorPalette::TertiaryDark]];}

.viewer table, table.twtable {border:2px solid [[ColorPalette::TertiaryDark]];}
.viewer th, .viewer thead td, .twtable th, .twtable thead td {background:[[ColorPalette::SecondaryMid]]; border:1px solid [[ColorPalette::TertiaryDark]]; color:[[ColorPalette::Background]];}
.viewer td, .viewer tr, .twtable td, .twtable tr {border:1px solid [[ColorPalette::TertiaryDark]];}

.viewer pre {border:1px solid [[ColorPalette::SecondaryLight]]; background:[[ColorPalette::SecondaryPale]];}
.viewer code {color:[[ColorPalette::SecondaryDark]];}
.viewer hr {border:0; border-top:dashed 1px [[ColorPalette::TertiaryDark]]; color:[[ColorPalette::TertiaryDark]];}

.highlight, .marked {background:[[ColorPalette::SecondaryLight]];}

.editor input {border:1px solid [[ColorPalette::PrimaryMid]];}
.editor textarea {border:1px solid [[ColorPalette::PrimaryMid]]; width:100%;}
.editorFooter {color:[[ColorPalette::TertiaryMid]];}
.readOnly {background:[[ColorPalette::TertiaryPale]];}

#backstageArea {background:[[ColorPalette::Foreground]]; color:[[ColorPalette::TertiaryMid]];}
#backstageArea a {background:[[ColorPalette::Foreground]]; color:[[ColorPalette::Background]]; border:none;}
#backstageArea a:hover {background:[[ColorPalette::SecondaryLight]]; color:[[ColorPalette::Foreground]]; }
#backstageArea a.backstageSelTab {background:[[ColorPalette::Background]]; color:[[ColorPalette::Foreground]];}
#backstageButton a {background:none; color:[[ColorPalette::Background]]; border:none;}
#backstageButton a:hover {background:[[ColorPalette::Foreground]]; color:[[ColorPalette::Background]]; border:none;}
#backstagePanel {background:[[ColorPalette::Background]]; border-color: [[ColorPalette::Background]] [[ColorPalette::TertiaryDark]] [[ColorPalette::TertiaryDark]] [[ColorPalette::TertiaryDark]];}
.backstagePanelFooter .button {border:none; color:[[ColorPalette::Background]];}
.backstagePanelFooter .button:hover {color:[[ColorPalette::Foreground]];}
#backstageCloak {background:[[ColorPalette::Foreground]]; opacity:0.6; filter:alpha(opacity=60);}
/*}}}*/
/*{{{*/
* html .tiddler {height:1%;}

body {font-size:.75em; font-family:arial,helvetica; margin:0; padding:0;}

h1,h2,h3,h4,h5,h6 {font-weight:bold; text-decoration:none;}
h1,h2,h3 {padding-bottom:1px; margin-top:1.2em;margin-bottom:0.3em;}
h4,h5,h6 {margin-top:1em;}
h1 {font-size:1.35em;}
h2 {font-size:1.25em;}
h3 {font-size:1.1em;}
h4 {font-size:1em;}
h5 {font-size:.9em;}

hr {height:1px;}

a {text-decoration:none;}

dt {font-weight:bold;}

ol {list-style-type:decimal;}
ol ol {list-style-type:lower-alpha;}
ol ol ol {list-style-type:lower-roman;}
ol ol ol ol {list-style-type:decimal;}
ol ol ol ol ol {list-style-type:lower-alpha;}
ol ol ol ol ol ol {list-style-type:lower-roman;}
ol ol ol ol ol ol ol {list-style-type:decimal;}

.txtOptionInput {width:11em;}

#contentWrapper .chkOptionInput {border:0;}

.externalLink {text-decoration:underline;}

.indent {margin-left:3em;}
.outdent {margin-left:3em; text-indent:-3em;}
code.escaped {white-space:nowrap;}

.tiddlyLinkExisting {font-weight:bold;}
.tiddlyLinkNonExisting {font-style:italic;}

/* the 'a' is required for IE, otherwise it renders the whole tiddler in bold */
a.tiddlyLinkNonExisting.shadow {font-weight:bold;}

#mainMenu .tiddlyLinkExisting,
	#mainMenu .tiddlyLinkNonExisting,
	#sidebarTabs .tiddlyLinkNonExisting {font-weight:normal; font-style:normal;}
#sidebarTabs .tiddlyLinkExisting {font-weight:bold; font-style:normal;}

.header {position:relative;}
.header a:hover {background:transparent;}
.headerShadow {position:relative; padding:4.5em 0 1em 1em; left:-1px; top:-1px;}
.headerForeground {position:absolute; padding:4.5em 0 1em 1em; left:0; top:0;}

.siteTitle {font-size:3em;}
.siteSubtitle {font-size:1.2em;}

#mainMenu {position:absolute; left:0; width:10em; text-align:right; line-height:1.6em; padding:1.5em 0.5em 0.5em 0.5em; font-size:1.1em;}

#sidebar {position:absolute; right:3px; width:16em; font-size:.9em;}
#sidebarOptions {padding-top:0.3em;}
#sidebarOptions a {margin:0 0.2em; padding:0.2em 0.3em; display:block;}
#sidebarOptions input {margin:0.4em 0.5em;}
#sidebarOptions .sliderPanel {margin-left:1em; padding:0.5em; font-size:.85em;}
#sidebarOptions .sliderPanel a {font-weight:bold; display:inline; padding:0;}
#sidebarOptions .sliderPanel input {margin:0 0 0.3em 0;}
#sidebarTabs .tabContents {width:15em; overflow:hidden;}

.wizard {padding:0.1em 1em 0 2em;}
.wizard h1 {font-size:2em; font-weight:bold; background:none; padding:0; margin:0.4em 0 0.2em;}
.wizard h2 {font-size:1.2em; font-weight:bold; background:none; padding:0; margin:0.4em 0 0.2em;}
.wizardStep {padding:1em 1em 1em 1em;}
.wizard .button {margin:0.5em 0 0; font-size:1.2em;}
.wizardFooter {padding:0.8em 0.4em 0.8em 0;}
.wizardFooter .status {padding:0 0.4em; margin-left:1em;}
.wizard .button {padding:0.1em 0.2em;}

#messageArea {position:fixed; top:2em; right:0; margin:0.5em; padding:0.5em; z-index:2000; _position:absolute;}
.messageToolbar {display:block; text-align:right; padding:0.2em;}
#messageArea a {text-decoration:underline;}

.tiddlerPopupButton {padding:0.2em;}
.popupTiddler {position: absolute; z-index:300; padding:1em; margin:0;}

.popup {position:absolute; z-index:300; font-size:.9em; padding:0; list-style:none; margin:0;}
.popup .popupMessage {padding:0.4em;}
.popup hr {display:block; height:1px; width:auto; padding:0; margin:0.2em 0;}
.popup li.disabled {padding:0.4em;}
.popup li a {display:block; padding:0.4em; font-weight:normal; cursor:pointer;}
.listBreak {font-size:1px; line-height:1px;}
.listBreak div {margin:2px 0;}

.tabset {padding:1em 0 0 0.5em;}
.tab {margin:0 0 0 0.25em; padding:2px;}
.tabContents {padding:0.5em;}
.tabContents ul, .tabContents ol {margin:0; padding:0;}
.txtMainTab .tabContents li {list-style:none;}
.tabContents li.listLink { margin-left:.75em;}

#contentWrapper {display:block;}
#splashScreen {display:none;}

#displayArea {margin:1em 17em 0 14em;}

.toolbar {text-align:right; font-size:.9em;}

.tiddler {padding:1em 1em 0;}

.missing .viewer,.missing .title {font-style:italic;}

.title {font-size:1.6em; font-weight:bold;}

.missing .subtitle {display:none;}
.subtitle {font-size:1.1em;}

.tiddler .button {padding:0.2em 0.4em;}

.tagging {margin:0.5em 0.5em 0.5em 0; float:left; display:none;}
.isTag .tagging {display:block;}
.tagged {margin:0.5em; float:right;}
.tagging, .tagged {font-size:0.9em; padding:0.25em;}
.tagging ul, .tagged ul {list-style:none; margin:0.25em; padding:0;}
.tagClear {clear:both;}

.footer {font-size:.9em;}
.footer li {display:inline;}

.annotation {padding:0.5em; margin:0.5em;}

* html .viewer pre {width:99%; padding:0 0 1em 0;}
.viewer {line-height:1.4em; padding-top:0.5em;}
.viewer .button {margin:0 0.25em; padding:0 0.25em;}
.viewer blockquote {line-height:1.5em; padding-left:0.8em;margin-left:2.5em;}
.viewer ul, .viewer ol {margin-left:0.5em; padding-left:1.5em;}

.viewer table, table.twtable {border-collapse:collapse; margin:0.8em 1.0em;}
.viewer th, .viewer td, .viewer tr,.viewer caption,.twtable th, .twtable td, .twtable tr,.twtable caption {padding:3px;}
table.listView {font-size:0.85em; margin:0.8em 1.0em;}
table.listView th, table.listView td, table.listView tr {padding:0 3px 0 3px;}

.viewer pre {padding:0.5em; margin-left:0.5em; font-size:1.2em; line-height:1.4em; overflow:auto;}
.viewer code {font-size:1.2em; line-height:1.4em;}

.editor {font-size:1.1em;}
.editor input, .editor textarea {display:block; width:100%; font:inherit;}
.editorFooter {padding:0.25em 0; font-size:.9em;}
.editorFooter .button {padding-top:0; padding-bottom:0;}

.fieldsetFix {border:0; padding:0; margin:1px 0px;}

.zoomer {font-size:1.1em; position:absolute; overflow:hidden;}
.zoomer div {padding:1em;}

* html #backstage {width:99%;}
* html #backstageArea {width:99%;}
#backstageArea {display:none; position:relative; overflow: hidden; z-index:150; padding:0.3em 0.5em;}
#backstageToolbar {position:relative;}
#backstageArea a {font-weight:bold; margin-left:0.5em; padding:0.3em 0.5em;}
#backstageButton {display:none; position:absolute; z-index:175; top:0; right:0;}
#backstageButton a {padding:0.1em 0.4em; margin:0.1em;}
#backstage {position:relative; width:100%; z-index:50;}
#backstagePanel {display:none; z-index:100; position:absolute; width:90%; margin-left:3em; padding:1em;}
.backstagePanelFooter {padding-top:0.2em; float:right;}
.backstagePanelFooter a {padding:0.2em 0.4em;}
#backstageCloak {display:none; z-index:20; position:absolute; width:100%; height:100px;}

.whenBackstage {display:none;}
.backstageVisible .whenBackstage {display:block;}
/*}}}*/
/***
StyleSheet for use when a translation requires any css style changes.
This StyleSheet can be used directly by languages such as Chinese, Japanese and Korean which need larger font sizes.
***/
/*{{{*/
body {font-size:0.8em;}
#sidebarOptions {font-size:1.05em;}
#sidebarOptions a {font-style:normal;}
#sidebarOptions .sliderPanel {font-size:0.95em;}
.subtitle {font-size:0.8em;}
.viewer table.listView {font-size:0.95em;}
/*}}}*/
/*{{{*/
@media print {
#mainMenu, #sidebar, #messageArea, .toolbar, #backstageButton, #backstageArea {display: none !important;}
#displayArea {margin: 1em 1em 0em;}
noscript {display:none;} /* Fixes a feature in Firefox 1.5.0.2 where print preview displays the noscript content */
}
/*}}}*/
<!--{{{-->
<div class='toolbar' role='navigation' macro='toolbar [[ToolbarCommands::ViewToolbar]]'></div>
<div class='title' macro='view title'></div>
<div class='subtitle'><span macro='view modifier link'></span>, <span macro='view modified date'></span> (<span macro='message views.wikified.createdPrompt'></span> <span macro='view created date'></span>)</div>
<div class='tagging' macro='tagging'></div>
<div class='tagged' macro='tags'></div>
<div class='viewer' macro='view text wikified'></div>
<div class='tagClear'></div>
<!--}}}-->
[[StyleSheetTiddlySpace]]
[[StyleSheetTiddler]]
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] the ''//Test Plan//'' is a step-by-step plan to be followed during the verification or validaton of a product or process.
In mathematics, a unit vector in a normed vector space is a vector (often a spatial vector) whose length is 1 (the unit length). A unit vector is often denoted by a lowercase letter with a "hat", like this: i-hat (pronounced "i-hat").

In Euclidean space, the dot product of two unit vectors is simply the cosine of the angle between them. This follows from the formula for the dot product, since the lengths are both 1.

The normalized vector or versor $\Large \hat{u}$ of a non-zero vector u is the unit vector codirectional with u, i.e.,

$\Large \hat{u}$ = $\LARGE \frac{u}{\|u\|}$

where vector u between two pairs of vertical lines is the norm (or length) of vector u. The term normalized vector is sometimes used as a synonym for unit vector.

The elements of a basis are usually chosen to be unit vectors. Every vector in the space may be written as a linear combination of unit vectors. The most commonly encountered bases are Cartesian, polar, and spherical coordinates. Each uses different unit vectors according to the symmetry of the coordinate system. Since these systems are encountered in so many different contexts, it is not uncommon to encounter different naming conventions than those used here.
''5.6.3 Review output''

The output from the management review shall include any decisions and actions related to
a) improvements needed to maintain the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
In the [[FDA Regulations]] a ''Device Master File'' (DMF) means a compilation of records describing the design history of a finished device.


Compare [[Device Master Record]]
 Each manufacturer of any [[class III|Class III Medical Devices]] or [[class II|Class II Medical Devices]] device, and the [[class I devices|Class I Medical Devices]] listed below, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

The following class I devices are subject to design controls:
(i) Devices automated with computer software; and
(ii) The devices listed in the following chart.

|Section|Device|
|868.6810	|Catheter, Tracheobronchial Suction.|
|878.4460	|Glove, Surgeon's.|
|880.6760	|Restraint, Protective.|
|892.5650|System, Applicator, Radionuclide, Manual.|
|892.5740	|Source, Radionuclide Teletherapy.|
These regulations implement FDA's responsibilities and authority concerning the reports of corrections and removals provisions of the [[Safe Medical Devices Act]] of the 1990 (the SMDA).
The FDA requires manufacturers, importers and distributors to report any corrections or removals of a device undertaken to:
* Reduce a risk to health
* Remedy of a risk to health.
Compliance to safety is a highly important item during an [[FDA Inspection]]
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Failure Mode and Effect Analysis//'' (FMEA) is and inductive technique that assesses the frequency and consequence of individual fault modes related to a product functions and components.
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] a ''//Design Output//'' means the result of a design effort at each design phase and at the end of the total design effort. The total design outputs consist of the device, its packaging and labeling, the associated specifications and drawings, and the production and quality assurance specifications and procedures. The finished design output will be the basis for the [[Device Master Record]]
/***
|''Name:''|YourSearchPlugin|
|''Version:''|2.1.4 (2009-09-04)|
|''Source:''|http://tiddlywiki.abego-software.de/#YourSearchPlugin|
|''Author:''|UdoBorkowski (ub [at] abego-software [dot] de)|
|''Licence:''|[[BSD open source license (abego Software)|http://www.abego-software.de/legal/apl-v10.html]]|
|''Copyright:''|&copy; 2005-2009 [[abego Software|http://www.abego-software.de]]|
|''~CoreVersion:''|2.1.0|
|''Community:''|[[del.icio.us|http://del.icio.us/post?url=http://tiddlywiki.abego-software.de/index.html%23YourSearchPlugin]]|
|''Browser:''|Firefox 1.0.4+; Firefox 1.5; ~InternetExplorer 6.0|
!About YourSearch
YourSearch gives you a bunch of new features to simplify and speed up your daily searches in TiddlyWiki. It seamlessly integrates into the standard TiddlyWiki search: just start typing into the 'search' field and explore!

For more information see [[Help|YourSearch Help]].
!Compatibility
This plugin requires TiddlyWiki 2.1. 
Check the [[archive|http://tiddlywiki.abego-software.de/archive]] for ~YourSearchPlugins supporting older versions of TiddlyWiki.
!Source Code
***/
/***
This plugin's source code is compressed (and hidden). Use this [[link|http://tiddlywiki.abego-software.de/archive/YourSearchPlugin/Plugin-YourSearch-src.2.1.4.js]] to get the readable source code.
***/
///%
if(!version.extensions.YourSearchPlugin){version.extensions.YourSearchPlugin={major:2,minor:1,revision:4,source:"http://tiddlywiki.abego-software.de/#YourSearchPlugin",licence:"[[BSD open source license (abego Software)|http://www.abego-software.de/legal/apl-v10.html]]",copyright:"Copyright (c) abego Software GmbH, 2005-2009 (www.abego-software.de)"};if(!window.abego){window.abego={};}if(!Array.forEach){Array.forEach=function(_1,_2,_3){for(var i=0,_4=_1.length;i<_4;i++){_2.call(_3,_1[i],i,_1);}};Array.prototype.forEach=function(_5,_6){for(var i=0,_7=this.length;i<_7;i++){_5.call(_6,this[i],i,this);}};}abego.toInt=function(s,_8){if(!s){return _8;}var n=parseInt(s);return (n==NaN)?_8:n;};abego.createEllipsis=function(_9){var e=createTiddlyElement(_9,"span");e.innerHTML="&hellip;";};abego.shallowCopy=function(_a){if(!_a){return _a;}var _b={};for(var n in _a){_b[n]=_a[n];}return _b;};abego.copyOptions=function(_c){return !_c?{}:abego.shallowCopy(_c);};abego.countStrings=function(_d,s){if(!s){return 0;}var _e=s.length;var n=0;var _f=0;while(1){var i=_d.indexOf(s,_f);if(i<0){return n;}n++;_f=i+_e;}return n;};abego.getBracedText=function(_10,_11,_12){if(!_11){_11=0;}var re=/\{([^\}]*)\}/gm;re.lastIndex=_11;var m=re.exec(_10);if(m){var s=m[1];var _13=abego.countStrings(s,"{");if(!_13){if(_12){_12.lastIndex=re.lastIndex;}return s;}var len=_10.length;for(var i=re.lastIndex;i<len&&_13;i++){var c=_10.charAt(i);if(c=="{"){_13++;}else{if(c=="}"){_13--;}}}if(!_13){if(_12){_12.lastIndex=i-1;}return _10.substring(m.index+1,i-1);}}};abego.select=function(_14,_15,_16,_17){if(!_17){_17=[];}_14.forEach(function(t){if(_15.call(_16,t)){_17.push(t);}});return _17;};abego.consumeEvent=function(e){if(e.stopPropagation){e.stopPropagation();}if(e.preventDefault){e.preventDefault();}e.cancelBubble=true;e.returnValue=true;};abego.TiddlerFilterTerm=function(_18,_19){if(!_19){_19={};}var _1a=_18;if(!_19.textIsRegExp){_1a=_18.escapeRegExp();if(_19.fullWordMatch){_1a="\\b"+_1a+"\\b";}}var _1b=new RegExp(_1a,"m"+(_19.caseSensitive?"":"i"));this.tester=new abego.MultiFieldRegExpTester(_1b,_19.fields,_19.withExtendedFields);};abego.TiddlerFilterTerm.prototype.test=function(_1c){return this.tester.test(_1c);};abego.parseNewTiddlerCommandLine=function(s){var m=/(.*?)\.(?:\s+|$)([^#]*)(#.*)?/.exec(s);if(!m){m=/([^#]*)()(#.*)?/.exec(s);}if(m){var r;if(m[3]){var s2=m[3].replace(/#/g,"");r=s2.parseParams("tag");}else{r=[[]];}var _1d=m[2]?m[2].trim():"";r.push({name:"text",value:_1d});r[0].text=[_1d];return {title:m[1].trim(),params:r};}else{return {title:s.trim(),params:[[]]};}};abego.parseTiddlerFilterTerm=function(_1e,_1f,_20){var re=/\s*(?:(?:\{([^\}]*)\})|(?:(=)|([#%!])|(?:(\w+)\s*\:(?!\/\/))|(?:(?:("(?:(?:\\")|[^"])+")|(?:\/((?:(?:\\\/)|[^\/])+)\/)|(\w+\:\/\/[^\s]+)|([^\s\)\-\"]+)))))/mg;var _21={"!":"title","%":"text","#":"tags"};var _22={};var _23;re.lastIndex=_1f;while(1){var i=re.lastIndex;var m=re.exec(_1e);if(!m||m.index!=i){throw "Word or String literal expected";}if(m[1]){var _24={};var _25=abego.getBracedText(_1e,0,_24);if(!_25){throw "Invalid {...} syntax";}var f=Function("tiddler","return ("+_25+");");return {func:f,lastIndex:_24.lastIndex,markRE:null};}if(m[2]){_23=true;}else{if(m[3]){_22[_21[m[3]]]=1;}else{if(m[4]){_22[m[4]]=1;}else{var _26=m[6];var _27=m[5]?window.eval(m[5]):m[6]?m[6]:m[7]?m[7]:m[8];var _20=abego.copyOptions(_20);_20.fullWordMatch=_23;_20.textIsRegExp=_26;var _28=[];for(var n in _22){_28.push(n);}if(_28.length==0){_20.fields=_20.defaultFields;}else{_20.fields=_28;_20.withExtendedFields=false;}var _29=new abego.TiddlerFilterTerm(_27,_20);var _2a=_26?_27:_27.escapeRegExp();if(_2a&&_23){_2a="\\b"+_2a+"\\b";}return {func:function(_2b){return _29.test(_2b);},lastIndex:re.lastIndex,markRE:_2a?"(?:"+_2a+")":null};}}}}};abego.BoolExp=function(s,_2c,_2d){this.s=s;var _2e=_2d&&_2d.defaultOperationIs_OR;var _2f=/\s*(?:(\-|not)|(\())/gi;var _30=/\s*\)/g;var _31=/\s*(?:(and|\&\&)|(or|\|\|))/gi;var _32=/\s*[^\)\s]/g;var _33=/\s*(\-|not)?(\s*\()?/gi;var _34;var _35=function(_36){_33.lastIndex=_36;var m=_33.exec(s);var _37;var _38;if(m&&m.index==_36){_36+=m[0].length;_37=m[1];if(m[2]){var e=_34(_36);_30.lastIndex=e.lastIndex;if(!_30.exec(s)){throw "Missing ')'";}_38={func:e.func,lastIndex:_30.lastIndex,markRE:e.markRE};}}if(!_38){_38=_2c(s,_36,_2d);}if(_37){_38.func=(function(f){return function(_39){return !f(_39);};})(_38.func);_38.markRE=null;}return _38;};_34=function(_3a){var _3b=_35(_3a);while(1){var l=_3b.lastIndex;_31.lastIndex=l;var m=_31.exec(s);var _3c;var _3d;if(m&&m.index==l){_3c=!m[1];_3d=_35(_31.lastIndex);}else{try{_3d=_35(l);}catch(e){return _3b;}_3c=_2e;}_3b.func=(function(_3e,_3f,_40){return _40?function(_41){return _3e(_41)||_3f(_41);}:function(_42){return _3e(_42)&&_3f(_42);};})(_3b.func,_3d.func,_3c);_3b.lastIndex=_3d.lastIndex;if(!_3b.markRE){_3b.markRE=_3d.markRE;}else{if(_3d.markRE){_3b.markRE=_3b.markRE+"|"+_3d.markRE;}}}};var _43=_34(0);this.evalFunc=_43.func;if(_43.markRE){this.markRegExp=new RegExp(_43.markRE,_2d.caseSensitive?"mg":"img");}};abego.BoolExp.prototype.exec=function(){return this.evalFunc.apply(this,arguments);};abego.BoolExp.prototype.getMarkRegExp=function(){return this.markRegExp;};abego.BoolExp.prototype.toString=function(){return this.s;};abego.MultiFieldRegExpTester=function(re,_44,_45){this.re=re;this.fields=_44?_44:["title","text","tags"];this.withExtendedFields=_45;};abego.MultiFieldRegExpTester.prototype.test=function(_46){var re=this.re;for(var i=0;i<this.fields.length;i++){var s=store.getValue(_46,this.fields[i]);if(typeof s=="string"&&re.test(s)){return this.fields[i];}}if(this.withExtendedFields){return store.forEachField(_46,function(_47,_48,_49){return typeof _49=="string"&&re.test(_49)?_48:null;},true);}return null;};abego.TiddlerQuery=function(_4a,_4b,_4c,_4d,_4e){if(_4c){this.regExp=new RegExp(_4a,_4b?"mg":"img");this.tester=new abego.MultiFieldRegExpTester(this.regExp,_4d,_4e);}else{this.expr=new abego.BoolExp(_4a,abego.parseTiddlerFilterTerm,{defaultFields:_4d,caseSensitive:_4b,withExtendedFields:_4e});}this.getQueryText=function(){return _4a;};this.getUseRegExp=function(){return _4c;};this.getCaseSensitive=function(){return _4b;};this.getDefaultFields=function(){return _4d;};this.getWithExtendedFields=function(){return _4e;};};abego.TiddlerQuery.prototype.test=function(_4f){if(!_4f){return false;}if(this.regExp){return this.tester.test(_4f);}return this.expr.exec(_4f);};abego.TiddlerQuery.prototype.filter=function(_50){return abego.select(_50,this.test,this);};abego.TiddlerQuery.prototype.getMarkRegExp=function(){if(this.regExp){return "".search(this.regExp)>=0?null:this.regExp;}return this.expr.getMarkRegExp();};abego.TiddlerQuery.prototype.toString=function(){return (this.regExp?this.regExp:this.expr).toString();};abego.PageWiseRenderer=function(){this.firstIndexOnPage=0;};merge(abego.PageWiseRenderer.prototype,{setItems:function(_51){this.items=_51;this.setFirstIndexOnPage(0);},getMaxPagesInNavigation:function(){return 10;},getItemsCount:function(_52){return this.items?this.items.length:0;},getCurrentPageIndex:function(){return Math.floor(this.firstIndexOnPage/this.getItemsPerPage());},getLastPageIndex:function(){return Math.floor((this.getItemsCount()-1)/this.getItemsPerPage());},setFirstIndexOnPage:function(_53){this.firstIndexOnPage=Math.min(Math.max(0,_53),this.getItemsCount()-1);},getFirstIndexOnPage:function(){this.firstIndexOnPage=Math.floor(this.firstIndexOnPage/this.getItemsPerPage())*this.getItemsPerPage();return this.firstIndexOnPage;},getLastIndexOnPage:function(){return Math.min(this.getFirstIndexOnPage()+this.getItemsPerPage()-1,this.getItemsCount()-1);},onPageChanged:function(_54,_55){},renderPage:function(_56){if(_56.beginRendering){_56.beginRendering(this);}try{if(this.getItemsCount()){var _57=this.getLastIndexOnPage();var _58=-1;for(var i=this.getFirstIndexOnPage();i<=_57;i++){_58++;_56.render(this,this.items[i],i,_58);}}}finally{if(_56.endRendering){_56.endRendering(this);}}},addPageNavigation:function(_59){if(!this.getItemsCount()){return;}var _5a=this;var _5b=function(e){if(!e){var e=window.event;}abego.consumeEvent(e);var _5c=abego.toInt(this.getAttribute("page"),0);var _5d=_5a.getCurrentPageIndex();if(_5c==_5d){return;}var _5e=_5c*_5a.getItemsPerPage();_5a.setFirstIndexOnPage(_5e);_5a.onPageChanged(_5c,_5d);};var _5f;var _60=this.getCurrentPageIndex();var _61=this.getLastPageIndex();if(_60>0){_5f=createTiddlyButton(_59,"Previous","Go to previous page (Shortcut: Alt-'<')",_5b,"prev");_5f.setAttribute("page",(_60-1).toString());_5f.setAttribute("accessKey","<");}for(var i=-this.getMaxPagesInNavigation();i<this.getMaxPagesInNavigation();i++){var _62=_60+i;if(_62<0){continue;}if(_62>_61){break;}var _63=(i+_60+1).toString();var _64=_62==_60?"currentPage":"otherPage";_5f=createTiddlyButton(_59,_63,"Go to page %0".format([_63]),_5b,_64);_5f.setAttribute("page",(_62).toString());}if(_60<_61){_5f=createTiddlyButton(_59,"Next","Go to next page (Shortcut: Alt-'>')",_5b,"next");_5f.setAttribute("page",(_60+1).toString());_5f.setAttribute("accessKey",">");}}});abego.LimitedTextRenderer=function(){var _65=40;var _66=4;var _67=function(_68,_69,_6a){var n=_68.length;if(n==0){_68.push({start:_69,end:_6a});return;}var i=0;for(;i<n;i++){var _6b=_68[i];if(_6b.start<=_6a&&_69<=_6b.end){var r;var _6c=i+1;for(;_6c<n;_6c++){r=_68[_6c];if(r.start>_6a||_69>_6b.end){break;}}var _6d=_69;var _6e=_6a;for(var j=i;j<_6c;j++){r=_68[j];_6d=Math.min(_6d,r.start);_6e=Math.max(_6e,r.end);}_68.splice(i,_6c-i,{start:_6d,end:_6e});return;}if(_6b.start>_6a){break;}}_68.splice(i,0,{start:_69,end:_6a});};var _6f=function(_70){var _71=0;for(var i=0;i<_70.length;i++){var _72=_70[i];_71+=_72.end-_72.start;}return _71;};var _73=function(c){return (c>="a"&&c<="z")||(c>="A"&&c<="Z")||c=="_";};var _74=function(s,_75){if(!_73(s[_75])){return null;}for(var i=_75-1;i>=0&&_73(s[i]);i--){}var _76=i+1;var n=s.length;for(i=_75+1;i<n&&_73(s[i]);i++){}return {start:_76,end:i};};var _77=function(s,_78,_79){var _7a;if(_79){_7a=_74(s,_78);}else{if(_78<=0){return _78;}_7a=_74(s,_78-1);}if(!_7a){return _78;}if(_79){if(_7a.start>=_78-_66){return _7a.start;}if(_7a.end<=_78+_66){return _7a.end;}}else{if(_7a.end<=_78+_66){return _7a.end;}if(_7a.start>=_78-_66){return _7a.start;}}return _78;};var _7b=function(s,_7c){var _7d=[];if(_7c){var _7e=0;var n=s.length;var _7f=0;do{_7c.lastIndex=_7e;var _80=_7c.exec(s);if(_80){if(_7e<_80.index){var t=s.substring(_7e,_80.index);_7d.push({text:t});}_7d.push({text:_80[0],isMatch:true});_7e=_80.index+_80[0].length;}else{_7d.push({text:s.substr(_7e)});break;}}while(true);}else{_7d.push({text:s});}return _7d;};var _81=function(_82){var _83=0;for(var i=0;i<_82.length;i++){if(_82[i].isMatch){_83++;}}return _83;};var _84=function(s,_85,_86,_87,_88){var _89=Math.max(Math.floor(_88/(_87+1)),_65);var _8a=Math.max(_89-(_86-_85),0);var _8b=Math.min(Math.floor(_86+_8a/3),s.length);var _8c=Math.max(_8b-_89,0);_8c=_77(s,_8c,true);_8b=_77(s,_8b,false);return {start:_8c,end:_8b};};var _8d=function(_8e,s,_8f){var _90=[];var _91=_81(_8e);var pos=0;for(var i=0;i<_8e.length;i++){var t=_8e[i];var _92=t.text;if(t.isMatch){var _93=_84(s,pos,pos+_92.length,_91,_8f);_67(_90,_93.start,_93.end);}pos+=_92.length;}return _90;};var _94=function(s,_95,_96){var _97=_96-_6f(_95);while(_97>0){if(_95.length==0){_67(_95,0,_77(s,_96,false));return;}else{var _98=_95[0];var _99;var _9a;if(_98.start==0){_99=_98.end;if(_95.length>1){_9a=_95[1].start;}else{_67(_95,_99,_77(s,_99+_97,false));return;}}else{_99=0;_9a=_98.start;}var _9b=Math.min(_9a,_99+_97);_67(_95,_99,_9b);_97-=(_9b-_99);}}};var _9c=function(_9d,s,_9e,_9f,_a0){if(_9f.length==0){return;}var _a1=function(_a2,s,_a3,_a4,_a5){var t;var _a6;var pos=0;var i=0;var _a7=0;for(;i<_a3.length;i++){t=_a3[i];_a6=t.text;if(_a4<pos+_a6.length){_a7=_a4-pos;break;}pos+=_a6.length;}var _a8=_a5-_a4;for(;i<_a3.length&&_a8>0;i++){t=_a3[i];_a6=t.text.substr(_a7);_a7=0;if(_a6.length>_a8){_a6=_a6.substr(0,_a8);}if(t.isMatch){createTiddlyElement(_a2,"span",null,"marked",_a6);}else{createTiddlyText(_a2,_a6);}_a8-=_a6.length;}if(_a5<s.length){abego.createEllipsis(_a2);}};if(_9f[0].start>0){abego.createEllipsis(_9d);}var _a9=_a0;for(var i=0;i<_9f.length&&_a9>0;i++){var _aa=_9f[i];var len=Math.min(_aa.end-_aa.start,_a9);_a1(_9d,s,_9e,_aa.start,_aa.start+len);_a9-=len;}};this.render=function(_ab,s,_ac,_ad){if(s.length<_ac){_ac=s.length;}var _ae=_7b(s,_ad);var _af=_8d(_ae,s,_ac);_94(s,_af,_ac);_9c(_ab,s,_ae,_af,_ac);};};(function(){function _b0(msg){alert(msg);throw msg;};if(version.major<2||(version.major==2&&version.minor<1)){_b0("YourSearchPlugin requires TiddlyWiki 2.1 or newer.\n\nCheck the archive for YourSearch plugins\nsupporting older versions of TiddlyWiki.\n\nArchive: http://tiddlywiki.abego-software.de/archive");}abego.YourSearch={};var _b1;var _b2;var _b3=function(_b4){_b1=_b4;};var _b5=function(){return _b1?_b1:[];};var _b6=function(){return _b1?_b1.length:0;};var _b7=4;var _b8=10;var _b9=2;var _ba=function(s,re){var m=s.match(re);return m?m.length:0;};var _bb=function(_bc,_bd){var _be=_bd.getMarkRegExp();if(!_be){return 1;}var _bf=_bc.title.match(_be);var _c0=_bf?_bf.length:0;var _c1=_ba(_bc.getTags(),_be);var _c2=_bf?_bf.join("").length:0;var _c3=_bc.title.length>0?_c2/_bc.title.length:0;var _c4=_c0*_b7+_c1*_b9+_c3*_b8+1;return _c4;};var _c5=function(_c6,_c7,_c8,_c9,_ca,_cb){_b2=null;var _cc=_c6.reverseLookup("tags",_cb,false);try{var _cd=[];if(config.options.chkSearchInTitle){_cd.push("title");}if(config.options.chkSearchInText){_cd.push("text");}if(config.options.chkSearchInTags){_cd.push("tags");}_b2=new abego.TiddlerQuery(_c7,_c8,_c9,_cd,config.options.chkSearchExtendedFields);}catch(e){return [];}var _ce=_b2.filter(_cc);var _cf=abego.YourSearch.getRankFunction();for(var i=0;i<_ce.length;i++){var _d0=_ce[i];var _d1=_cf(_d0,_b2);_d0.searchRank=_d1;}if(!_ca){_ca="title";}var _d2=function(a,b){var _d3=a.searchRank-b.searchRank;if(_d3==0){if(a[_ca]==b[_ca]){return (0);}else{return (a[_ca]<b[_ca])?-1:+1;}}else{return (_d3>0)?-1:+1;}};_ce.sort(_d2);return _ce;};var _d4=80;var _d5=50;var _d6=250;var _d7=50;var _d8=25;var _d9=10;var _da="yourSearchResult";var _db="yourSearchResultItems";var _dc;var _dd;var _de;var _df;var _e0;var _e1=function(){if(version.extensions.YourSearchPlugin.styleSheetInited){return;}version.extensions.YourSearchPlugin.styleSheetInited=true;setStylesheet(store.getTiddlerText("YourSearchStyleSheet"),"yourSearch");};var _e2=function(){return _dd!=null&&_dd.parentNode==document.body;};var _e3=function(){if(_e2()){document.body.removeChild(_dd);}};var _e4=function(e){_e3();var _e5=this.getAttribute("tiddlyLink");if(_e5){var _e6=this.getAttribute("withHilite");var _e7=highlightHack;if(_e6&&_e6=="true"&&_b2){highlightHack=_b2.getMarkRegExp();}story.displayTiddler(this,_e5);highlightHack=_e7;}return (false);};var _e8=function(){if(!_de){return;}var _e9=_de;var _ea=findPosX(_e9);var _eb=findPosY(_e9);var _ec=_e9.offsetHeight;var _ed=_ea;var _ee=_eb+_ec;var _ef=findWindowWidth();if(_ef<_dd.offsetWidth){_dd.style.width=(_ef-100)+"px";_ef=findWindowWidth();}var _f0=_dd.offsetWidth;if(_ed+_f0>_ef){_ed=_ef-_f0-30;}if(_ed<0){_ed=0;}_dd.style.left=_ed+"px";_dd.style.top=_ee+"px";_dd.style.display="block";};var _f1=function(){if(_dd){window.scrollTo(0,ensureVisible(_dd));}if(_de){window.scrollTo(0,ensureVisible(_de));}};var _f2=function(){_e8();_f1();};var _f3;var _f4;var _f5=new abego.PageWiseRenderer();var _f6=function(_f7){this.itemHtml=store.getTiddlerText("YourSearchItemTemplate");if(!this.itemHtml){_b0("YourSearchItemTemplate not found");}this.place=document.getElementById(_db);if(!this.place){this.place=createTiddlyElement(_f7,"div",_db);}};merge(_f6.prototype,{render:function(_f8,_f9,_fa,_fb){_f3=_fb;_f4=_f9;var _fc=createTiddlyElement(this.place,"div",null,"yourSearchItem");_fc.innerHTML=this.itemHtml;applyHtmlMacros(_fc,null);refreshElements(_fc,null);},endRendering:function(_fd){_f4=null;}});var _fe=function(){if(!_dd||!_de){return;}var _ff=store.getTiddlerText("YourSearchResultTemplate");if(!_ff){_ff="<b>Tiddler YourSearchResultTemplate not found</b>";}_dd.innerHTML=_ff;applyHtmlMacros(_dd,null);refreshElements(_dd,null);var _100=new _f6(_dd);_f5.renderPage(_100);_f2();};_f5.getItemsPerPage=function(){var n=(config.options.chkPreviewText)?abego.toInt(config.options.txtItemsPerPageWithPreview,_d9):abego.toInt(config.options.txtItemsPerPage,_d8);return (n>0)?n:1;};_f5.onPageChanged=function(){_fe();};var _101=function(){if(_de==null||!config.options.chkUseYourSearch){return;}if((_de.value==_dc)&&_dc&&!_e2()){if(_dd&&(_dd.parentNode!=document.body)){document.body.appendChild(_dd);_f2();}else{abego.YourSearch.onShowResult(true);}}};var _102=function(){_e3();_dd=null;_dc=null;};var _103=function(self,e){while(e!=null){if(self==e){return true;}e=e.parentNode;}return false;};var _104=function(e){if(e.target==_de){return;}if(e.target==_df){return;}if(_dd&&_103(_dd,e.target)){return;}_e3();};var _105=function(e){if(e.keyCode==27){_e3();}};addEvent(document,"click",_104);addEvent(document,"keyup",_105);var _106=function(text,_107,_108){_dc=text;_b3(_c5(store,text,_107,_108,"title","excludeSearch"));abego.YourSearch.onShowResult();};var _109=function(_10a,_10b,_10c,_10d,_10e,_10f){_e1();_dc="";var _110=null;var _111=function(txt){if(config.options.chkUseYourSearch){_106(txt.value,config.options.chkCaseSensitiveSearch,config.options.chkRegExpSearch);}else{story.search(txt.value,config.options.chkCaseSensitiveSearch,config.options.chkRegExpSearch);}_dc=txt.value;};var _112=function(e){_111(_de);return false;};var _113=function(e){if(!e){var e=window.event;}_de=this;switch(e.keyCode){case 13:if(e.ctrlKey&&_e0&&_e2()){_e0.onclick.apply(_e0,[e]);}else{_111(this);}break;case 27:if(_e2()){_e3();}else{this.value="";clearMessage();}break;}if(String.fromCharCode(e.keyCode)==this.accessKey||e.altKey){_101();}if(this.value.length<3&&_110){clearTimeout(_110);}if(this.value.length>2){if(this.value!=_dc){if(!config.options.chkUseYourSearch||config.options.chkSearchAsYouType){if(_110){clearTimeout(_110);}var txt=this;_110=setTimeout(function(){_111(txt);},500);}}else{if(_110){clearTimeout(_110);}}}if(this.value.length==0){_e3();}};var _114=function(e){this.select();clearMessage();_101();};var args=_10e.parseParams("list",null,true);var _115=getFlag(args,"buttonAtRight");var _116=getParam(args,"sizeTextbox",this.sizeTextbox);var btn;if(!_115){btn=createTiddlyButton(_10a,this.label,this.prompt,_112);}var txt=createTiddlyElement(null,"input",null,null,null);if(_10c[0]){txt.value=_10c[0];}txt.onkeyup=_113;txt.onfocus=_114;txt.setAttribute("size",_116);txt.setAttribute("accessKey",this.accessKey);txt.setAttribute("autocomplete","off");if(config.browser.isSafari){txt.setAttribute("type","search");txt.setAttribute("results","5");}else{txt.setAttribute("type","text");}if(_10a){_10a.appendChild(txt);}if(_115){btn=createTiddlyButton(_10a,this.label,this.prompt,_112);}_de=txt;_df=btn;};var _117=function(){_e3();var _118=_b5();var n=_118.length;if(n){var _119=[];for(var i=0;i<n;i++){_119.push(_118[i].title);}story.displayTiddlers(null,_119);}};var _11a=function(_11b,_11c,_11d,_11e){invokeMacro(_11b,"option",_11c,_11d,_11e);var elem=_11b.lastChild;var _11f=elem.onclick;elem.onclick=function(e){var _120=_11f.apply(this,arguments);_fe();return _120;};return elem;};var _121=function(s){var _122=["''","{{{","}}}","//","<<<","/***","***/"];var _123="";for(var i=0;i<_122.length;i++){if(i!=0){_123+="|";}_123+="("+_122[i].escapeRegExp()+")";}return s.replace(new RegExp(_123,"mg"),"").trim();};var _124=function(){var i=_f3;return (i>=0&&i<=9)?(i<9?(i+1):0):-1;};var _125=new abego.LimitedTextRenderer();var _126=function(_127,s,_128){_125.render(_127,s,_128,_b2.getMarkRegExp());};var _129=TiddlyWiki.prototype.saveTiddler;TiddlyWiki.prototype.saveTiddler=function(_12a,_12b,_12c,_12d,_12e,tags,_12f){_129.apply(this,arguments);_102();};var _130=TiddlyWiki.prototype.removeTiddler;TiddlyWiki.prototype.removeTiddler=function(_131){_130.apply(this,arguments);_102();};config.macros.yourSearch={label:"yourSearch",prompt:"Gives access to the current/last YourSearch result",handler:function(_132,_133,_134,_135,_136,_137){if(_134.length==0){return;}var name=_134[0];var func=config.macros.yourSearch.funcs[name];if(func){func(_132,_133,_134,_135,_136,_137);}},tests:{"true":function(){return true;},"false":function(){return false;},"found":function(){return _b6()>0;},"previewText":function(){return config.options.chkPreviewText;}},funcs:{itemRange:function(_138){if(_b6()){var _139=_f5.getLastIndexOnPage();var s="%0 - %1".format([_f5.getFirstIndexOnPage()+1,_139+1]);createTiddlyText(_138,s);}},count:function(_13a){createTiddlyText(_13a,_b6().toString());},query:function(_13b){if(_b2){createTiddlyText(_13b,_b2.toString());}},version:function(_13c){var t="YourSearch %0.%1.%2".format([version.extensions.YourSearchPlugin.major,version.extensions.YourSearchPlugin.minor,version.extensions.YourSearchPlugin.revision]);var e=createTiddlyElement(_13c,"a");e.setAttribute("href","http://tiddlywiki.abego-software.de/#YourSearchPlugin");e.innerHTML="<font color=\"black\" face=\"Arial, Helvetica, sans-serif\">"+t+"<font>";},copyright:function(_13d){var e=createTiddlyElement(_13d,"a");e.setAttribute("href","http://www.abego-software.de");e.innerHTML="<font color=\"black\" face=\"Arial, Helvetica, sans-serif\">&copy; 2005-2008 <b><font color=\"red\">abego</font></b> Software<font>";},newTiddlerButton:function(_13e){if(_b2){var r=abego.parseNewTiddlerCommandLine(_b2.getQueryText());var btn=config.macros.newTiddler.createNewTiddlerButton(_13e,r.title,r.params,"new tiddler","Create a new tiddler based on search text. (Shortcut: Ctrl-Enter; Separators: '.', '#')",null,"text");var _13f=btn.onclick;btn.onclick=function(){_e3();_13f.apply(this,arguments);};_e0=btn;}},linkButton:function(_140,_141,_142,_143,_144,_145){if(_142<2){return;}var _146=_142[1];var text=_142<3?_146:_142[2];var _147=_142<4?text:_142[3];var _148=_142<5?null:_142[4];var btn=createTiddlyButton(_140,text,_147,_e4,null,null,_148);btn.setAttribute("tiddlyLink",_146);},closeButton:function(_149,_14a,_14b,_14c,_14d,_14e){var _14f=createTiddlyButton(_149,"close","Close the Search Results (Shortcut: ESC)",_e3);},openAllButton:function(_150,_151,_152,_153,_154,_155){var n=_b6();if(n==0){return;}var _156=n==1?"open tiddler":"open all %0 tiddlers".format([n]);var _157=createTiddlyButton(_150,_156,"Open all found tiddlers (Shortcut: Alt-O)",_117);_157.setAttribute("accessKey","O");},naviBar:function(_158,_159,_15a,_15b,_15c,_15d){_f5.addPageNavigation(_158);},"if":function(_15e,_15f,_160,_161,_162,_163){if(_160.length<2){return;}var _164=_160[1];var _165=(_164=="not");if(_165){if(_160.length<3){return;}_164=_160[2];}var test=config.macros.yourSearch.tests[_164];var _166=false;try{if(test){_166=test(_15e,_15f,_160,_161,_162,_163)!=_165;}else{_166=(!eval(_164))==_165;}}catch(ex){}if(!_166){_15e.style.display="none";}},chkPreviewText:function(_167,_168,_169,_16a,_16b,_16c){var _16d=_169.slice(1).join(" ");var elem=_11a(_167,"chkPreviewText",_16a,_16c);elem.setAttribute("accessKey","P");elem.title="Show text preview of found tiddlers (Shortcut: Alt-P)";return elem;}}};config.macros.foundTiddler={label:"foundTiddler",prompt:"Provides information on the tiddler currently processed on the YourSearch result page",handler:function(_16e,_16f,_170,_171,_172,_173){var name=_170[0];var func=config.macros.foundTiddler.funcs[name];if(func){func(_16e,_16f,_170,_171,_172,_173);}},funcs:{title:function(_174,_175,_176,_177,_178,_179){if(!_f4){return;}var _17a=_124();var _17b=_17a>=0?"Open tiddler (Shortcut: Alt-%0)".format([_17a.toString()]):"Open tiddler";var btn=createTiddlyButton(_174,null,_17b,_e4,null);btn.setAttribute("tiddlyLink",_f4.title);btn.setAttribute("withHilite","true");_126(btn,_f4.title,_d4);if(_17a>=0){btn.setAttribute("accessKey",_17a.toString());}},tags:function(_17c,_17d,_17e,_17f,_180,_181){if(!_f4){return;}_126(_17c,_f4.getTags(),_d5);},text:function(_182,_183,_184,_185,_186,_187){if(!_f4){return;}_126(_182,_121(_f4.text),_d6);},field:function(_188,_189,_18a,_18b,_18c,_18d){if(!_f4){return;}var name=_18a[1];var len=_18a.length>2?abego.toInt(_18a[2],_d7):_d7;var v=store.getValue(_f4,name);if(v){_126(_188,_121(v),len);}},number:function(_18e,_18f,_190,_191,_192,_193){var _194=_124();if(_194>=0){var text="%0)".format([_194.toString()]);createTiddlyElement(_18e,"span",null,"shortcutNumber",text);}}}};var opts={chkUseYourSearch:true,chkPreviewText:true,chkSearchAsYouType:true,chkSearchInTitle:true,chkSearchInText:true,chkSearchInTags:true,chkSearchExtendedFields:true,txtItemsPerPage:_d8,txtItemsPerPageWithPreview:_d9};for(var n in opts){if(config.options[n]==undefined){config.options[n]=opts[n];}}config.shadowTiddlers.AdvancedOptions+="\n<<option chkUseYourSearch>> Use 'Your Search' //([[more options|YourSearch Options]]) ([[help|YourSearch Help]])// ";config.shadowTiddlers["YourSearch Help"]="!Field Search\nWith the Field Search you can restrict your search to certain fields of a tiddler, e.g"+" only search the tags or only the titles. The general form is //fieldname//'':''//textToSearch// (e."+"g. {{{title:intro}}}). In addition one-character shortcuts are also supported for the standard field"+"s {{{title}}}, {{{text}}} and {{{tags}}}:\n|!What you want|!What you type|!Example|\n|Search ''titles "+"only''|start word with ''!''|{{{!jonny}}} (shortcut for {{{title:jonny}}})|\n|Search ''contents/text "+"only''|start word with ''%''|{{{%football}}} (shortcut for {{{text:football}}})|\n|Search ''tags only"+"''|start word with ''#''|{{{#Plugin}}} (shortcut for {{{tags:Plugin}}})|\n\nUsing this feature you may"+" also search the extended fields (\"Metadata\") introduced with TiddlyWiki 2.1, e.g. use {{{priority:1"+"}}} to find all tiddlers with the priority field set to \"1\".\n\nYou may search a word in more than one"+" field. E.g. {{{!#Plugin}}} (or {{{title:tags:Plugin}}} in the \"long form\") finds tiddlers containin"+"g \"Plugin\" either in the title or in the tags (but does not look for \"Plugin\" in the text). \n\n!Boole"+"an Search\nThe Boolean Search is useful when searching for multiple words.\n|!What you want|!What you "+"type|!Example|\n|''All words'' must exist|List of words|{{{jonny jeremy}}} (or {{{jonny and jeremy}}}"+")|\n|''At least one word'' must exist|Separate words by ''or''|{{{jonny or jeremy}}}|\n|A word ''must "+"not exist''|Start word with ''-''|{{{-jonny}}} (or {{{not jonny}}})|\n\n''Note:'' When you specify two"+" words, separated with a space, YourSearch finds all tiddlers that contain both words, but not neces"+"sarily next to each other. If you want to find a sequence of word, e.g. '{{{John Brown}}}', you need"+" to put the words into quotes. I.e. you type: {{{\"john brown\"}}}.\n\nUsing parenthesis you may change "+"the default \"left to right\" evaluation of the boolean search. E.g. {{{not (jonny or jeremy)}}} finds"+" all tiddlers that contain neither \"jonny\" nor \"jeremy. In contrast to this {{{not jonny or jeremy}}"+"} (i.e. without parenthesis) finds all tiddlers that either don't contain \"jonny\" or that contain \"j"+"eremy\".\n\n!'Exact Word' Search\nBy default a search result all matches that 'contain' the searched tex"+"t. E.g. if you search for {{{Task}}} you will get all tiddlers containing 'Task', but also '~Complet"+"edTask', '~TaskForce' etc.\n\nIf you only want to get the tiddlers that contain 'exactly the word' you"+" need to prefix it with a '='. E.g. typing '=Task' will find the tiddlers that contain the word 'Tas"+"k', ignoring words that just contain 'Task' as a substring.\n\n!~CaseSensitiveSearch and ~RegExpSearch"+"\nThe standard search options ~CaseSensitiveSearch and ~RegExpSearch are fully supported by YourSearc"+"h. However when ''~RegExpSearch'' is on Filtered and Boolean Search are disabled.\n\nIn addition you m"+"ay do a \"regular expression\" search even with the ''~RegExpSearch'' set to false by directly enterin"+"g the regular expression into the search field, framed with {{{/.../}}}. \n\nExample: {{{/m[ae][iy]er/"+"}}} will find all tiddlers that contain either \"maier\", \"mayer\", \"meier\" or \"meyer\".\n\n!~JavaScript E"+"xpression Filtering\nIf you are familiar with JavaScript programming and know some TiddlyWiki interna"+"ls you may also use JavaScript expression for the search. Just enter a JavaScript boolean expression"+" into the search field, framed with {{{ { ... } }}}. In the code refer to the variable tiddler and e"+"valuate to {{{true}}} when the given tiddler should be included in the result. \n\nExample: {{{ { tidd"+"ler.modified > new Date(\"Jul 4, 2005\")} }}} returns all tiddler modified after July 4th, 2005.\n\n!Com"+"bined Search\nYou are free to combine the various search options. \n\n''Examples''\n|!What you type|!Res"+"ult|\n|{{{!jonny !jeremy -%football}}}|all tiddlers with both {{{jonny}}} and {{{jeremy}}} in its tit"+"les, but no {{{football}}} in content.|\n|{{{#=Task}}}|All tiddlers tagged with 'Task' (the exact wor"+"d). Tags named '~CompletedTask', '~TaskForce' etc. are not considered.|\n\n!Access Keys\nYou are encour"+"aged to use the access keys (also called \"shortcut\" keys) for the most frequently used operations. F"+"or quick reference these shortcuts are also mentioned in the tooltip for the various buttons etc.\n\n|"+"!Key|!Operation|\n|{{{Alt-F}}}|''The most important keystroke'': It moves the cursor to the search in"+"put field so you can directly start typing your query. Pressing {{{Alt-F}}} will also display the pr"+"evious search result. This way you can quickly display multiple tiddlers using \"Press {{{Alt-F}}}. S"+"elect tiddler.\" sequences.|\n|{{{ESC}}}|Closes the [[YourSearch Result]]. When the [[YourSearch Resul"+"t]] is already closed and the cursor is in the search input field the field's content is cleared so "+"you start a new query.|\n|{{{Alt-1}}}, {{{Alt-2}}},... |Pressing these keys opens the first, second e"+"tc. tiddler from the result list.|\n|{{{Alt-O}}}|Opens all found tiddlers.|\n|{{{Alt-P}}}|Toggles the "+"'Preview Text' mode.|\n|{{{Alt-'<'}}}, {{{Alt-'>'}}}|Displays the previous or next page in the [[Your"+"Search Result]].|\n|{{{Return}}}|When you have turned off the 'as you type' search mode pressing the "+"{{{Return}}} key actually starts the search (as does pressing the 'search' button).|\n\n//If some of t"+"hese shortcuts don't work for you check your browser if you have other extensions installed that alr"+"eady \"use\" these shortcuts.//";config.shadowTiddlers["YourSearch Options"]="|>|!YourSearch Options|\n|>|<<option chkUseYourSearch>> Use 'Your Search'|\n|!|<<option chkPreviewText"+">> Show Text Preview|\n|!|<<option chkSearchAsYouType>> 'Search As You Type' Mode (No RETURN required"+" to start search)|\n|!|Default Search Filter:<<option chkSearchInTitle>>Title ('!')     <<option chk"+"SearchInText>>Text ('%')     <<option chkSearchInTags>>Tags ('#')    <<option chkSearchExtendedFiel"+"ds>>Extended Fields<html><br><font size=\"-2\">The fields of a tiddlers that are searched when you don"+"'t explicitly specify a filter in the search text <br>(Explictly specify fields using one or more '!"+"', '%', '#' or 'fieldname:' prefix before the word/text to find).</font></html>|\n|!|Number of items "+"on search result page: <<option txtItemsPerPage>>|\n|!|Number of items on search result page with pre"+"view text: <<option txtItemsPerPageWithPreview>>|\n";config.shadowTiddlers["YourSearchStyleSheet"]="/***\n!~YourSearchResult Stylesheet\n***/\n/*{{{*/\n.yourSearchResult {\n\tposition: absolute;\n\twidth: 800"+"px;\n\n\tpadding: 0.2em;\n\tlist-style: none;\n\tmargin: 0;\n\n\tbackground: #ffd;\n\tborder: 1px solid DarkGra"+"y;\n}\n\n/*}}}*/\n/***\n!!Summary Section\n***/\n/*{{{*/\n.yourSearchResult .summary {\n\tborder-bottom-width:"+" thin;\n\tborder-bottom-style: solid;\n\tborder-bottom-color: #999999;\n\tpadding-bottom: 4px;\n}\n\n.yourSea"+"rchRange, .yourSearchCount, .yourSearchQuery   {\n\tfont-weight: bold;\n}\n\n.yourSearchResult .summary ."+"button {\n\tfont-size: 10px;\n\n\tpadding-left: 0.3em;\n\tpadding-right: 0.3em;\n}\n\n.yourSearchResult .summa"+"ry .chkBoxLabel {\n\tfont-size: 10px;\n\n\tpadding-right: 0.3em;\n}\n\n/*}}}*/\n/***\n!!Items Area\n***/\n/*{{{*"+"/\n.yourSearchResult .marked {\n\tbackground: none;\n\tfont-weight: bold;\n}\n\n.yourSearchItem {\n\tmargin-to"+"p: 2px;\n}\n\n.yourSearchNumber {\n\tcolor: #808080;\n}\n\n\n.yourSearchTags {\n\tcolor: #008000;\n}\n\n.yourSearc"+"hText {\n\tcolor: #808080;\n\tmargin-bottom: 6px;\n}\n\n/*}}}*/\n/***\n!!Footer\n***/\n/*{{{*/\n.yourSearchFoote"+"r {\n\tmargin-top: 8px;\n\tborder-top-width: thin;\n\tborder-top-style: solid;\n\tborder-top-color: #999999;"+"\n}\n\n.yourSearchFooter a:hover{\n\tbackground: none;\n\tcolor: none;\n}\n/*}}}*/\n/***\n!!Navigation Bar\n***/"+"\n/*{{{*/\n.yourSearchNaviBar a {\n\tfont-size: 16px;\n\tmargin-left: 4px;\n\tmargin-right: 4px;\n\tcolor: bla"+"ck;\n\ttext-decoration: underline;\n}\n\n.yourSearchNaviBar a:hover {\n\tbackground-color: none;\n}\n\n.yourSe"+"archNaviBar .prev {\n\tfont-weight: bold;\n\tcolor: blue;\n}\n\n.yourSearchNaviBar .currentPage {\n\tcolor: #"+"FF0000;\n\tfont-weight: bold;\n\ttext-decoration: none;\n}\n\n.yourSearchNaviBar .next {\n\tfont-weight: bold"+";\n\tcolor: blue;\n}\n/*}}}*/\n";config.shadowTiddlers["YourSearchResultTemplate"]="<!--\n{{{\n-->\n<span macro=\"yourSearch if found\">\n<!-- The Summary Header ============================"+"================ -->\n<table class=\"summary\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\">"+"<tbody>\n  <tr>\n\t<td align=\"left\">\n\t\tYourSearch Result <span class=\"yourSearchRange\" macro=\"yourSearc"+"h itemRange\"></span>\n\t\t&nbsp;of&nbsp;<span class=\"yourSearchCount\" macro=\"yourSearch count\"></span>\n"+"\t\tfor&nbsp;<span class=\"yourSearchQuery\" macro=\"yourSearch query\"></span>\n\t</td>\n\t<td class=\"yourSea"+"rchButtons\" align=\"right\">\n\t\t<span macro=\"yourSearch chkPreviewText\"></span><span class=\"chkBoxLabel"+"\">preview text</span>\n\t\t<span macro=\"yourSearch newTiddlerButton\"></span>\n\t\t<span macro=\"yourSearch openAllButton\"></span>\n\t\t<span macro=\"yourSearch lin"+"kButton 'YourSearch Options' options 'Configure YourSearch'\"></span>\n\t\t<span macro=\"yourSearch linkB"+"utton 'YourSearch Help' help 'Get help how to use YourSearch'\"></span>\n\t\t<span macro=\"yourSearch clo"+"seButton\"></span>\n\t</td>\n  </tr>\n</tbody></table>\n\n<!-- The List of Found Tiddlers ================="+"=========================== -->\n<div id=\"yourSearchResultItems\" itemsPerPage=\"25\" itemsPerPageWithPr"+"eview=\"10\"></div>\n\n<!-- The Footer (with the Navigation) ==========================================="+"= -->\n<table class=\"yourSearchFooter\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\"><tbody"+">\n  <tr>\n\t<td align=\"left\">\n\t\tResult page: <span class=\"yourSearchNaviBar\" macro=\"yourSearch naviBar"+"\"></span>\n\t</td>\n\t<td align=\"right\"><span macro=\"yourSearch version\"></span>, <span macro=\"yourSearc"+"h copyright\"></span>\n\t</td>\n  </tr>\n</tbody></table>\n<!-- end of the 'tiddlers found' case ========="+"================================== -->\n</span>\n\n\n<!-- The \"No tiddlers found\" case ================="+"========================== -->\n<span macro=\"yourSearch if not found\">\n<table class=\"summary\" border="+"\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"0\"><tbody>\n  <tr>\n\t<td align=\"left\">\n\t\tYourSearch Resu"+"lt: No tiddlers found for <span class=\"yourSearchQuery\" macro=\"yourSearch query\"></span>.\n\t</td>\n\t<t"+"d class=\"yourSearchButtons\" align=\"right\">\n\t\t<span macro=\"yourSearch newTiddlerButton\"></span>\n\t\t<span macro=\"yourSearch linkButton 'YourSearch Options'"+" options 'Configure YourSearch'\"></span>\n\t\t<span macro=\"yourSearch linkButton 'YourSearch Help' help"+" 'Get help how to use YourSearch'\"></span>\n\t\t<span macro=\"yourSearch closeButton\"></span>\n\t</td>\n  <"+"/tr>\n</tbody></table>\n</span>\n\n\n<!--\n}}}\n-->\n";config.shadowTiddlers["YourSearchItemTemplate"]="<!--\n{{{\n-->\n<span class='yourSearchNumber' macro='foundTiddler number'></span>\n<span class='yourSea"+"rchTitle' macro='foundTiddler title'/></span>&nbsp;-&nbsp;\n<span class='yourSearchTags' macro='found"+"Tiddler field tags 50'/></span>\n<span macro=\"yourSearch if previewText\"><div class='yourSearchText' macro='fo"+"undTiddler field text 250'/></div></span>\n<!--\n}}}\n-->";config.shadowTiddlers["YourSearch"]="<<tiddler [[YourSearch Help]]>>";config.shadowTiddlers["YourSearch Result"]="The popup-like window displaying the result of a YourSearch query.";config.macros.search.handler=_109;var _195=function(){if(config.macros.search.handler!=_109){alert("Message from YourSearchPlugin:\n\n\nAnother plugin has disabled the 'Your Search' features.\n\n\nYou may "+"disable the other plugin or change the load order of \nthe plugins (by changing the names of the tidd"+"lers)\nto enable the 'Your Search' features.");}};setTimeout(_195,5000);abego.YourSearch.getStandardRankFunction=function(){return _bb;};abego.YourSearch.getRankFunction=function(){return abego.YourSearch.getStandardRankFunction();};abego.YourSearch.getCurrentTiddler=function(){return _f4;};abego.YourSearch.closeResult=function(){_e3();};abego.YourSearch.getFoundTiddlers=function(){return _b1;};abego.YourSearch.getQuery=function(){return _b2;};abego.YourSearch.onShowResult=function(_196){highlightHack=_b2?_b2.getMarkRegExp():null;if(!_196){_f5.setItems(_b5());}if(!_dd){_dd=createTiddlyElement(document.body,"div",_da,"yourSearchResult");}else{if(_dd.parentNode!=document.body){document.body.appendChild(_dd);}}_fe();highlightHack=null;};})();}
//%/
Class II Medical Devices are more complicated and present greater risk than Class I devices. Class II devices are subject to FDA's [[General Controls]]. Furthermore, because those controls do not provide reasonable assurance of the device safety and effectiveness, these devices are subject to any specific performance standards, postmarket surveillance, patient registry, guidelines, and premarket notification requirements promulgated by the FDA.

Class II Medical Devices have the potential to pose a mild risk to a patient if used incorrectly. General controls alone are not adequate to assure the safety and effectiveness of the device.  Due to these risks, special controls must be implemented in addition to general controls. Class II devices typically require pre-market notification by submission and FDA review of a 510(k) clearance to market submission. Special Controls applicable to Class II Devices are as follows.
# [[Special labeling requirements]],
# [[Mandatory performance standards]], both International and United States
# [[Postmarket surveillance]]
# [[FDA medical device specific guidance]]
!Examples
Examples of Class II devices include physiologic monitors, x-ray systems, gas analyzers, pumps, and surgical drapes:
<<image /static/files/FDA/Example%20Class%20II.jpg width:600>>

See also: [[Premarket notification]]
''Clause 0: Introduction''

* Can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development,and provision of related services.
* Question: does your organisation has related services?
* It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements
* Based on a process approach to quality management. Any activity that receives inputs and converts them to outputs can be considered as a proces

Clause 0: ISO13485 difference with ISO9001:2008
ISO13485 focus on
# Meeting customer requirements
# Maintenance of continuing (continuous) effectiveness of the Q system
# Regulatory, safety & effectiveness
ISO9001 focus on
# Customer satisfaction
# Continual improvement
## Format chapters ISO13485 follow ISO9001:2008
## Effectiveness is focus, not efficient!
## Differences with respect to ISO9001 in blue italic
Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
!Attention points
* Design inputs are often referred to as [[Requirements]]
* Among the activities that need to be documented are:
** Intended use
** User needs
** Patient needs
** A mechanism for addressing incomplete, ambigious or conflicting requirements
** Design and development interfaces
* A good mechanism to control design input documentation is a [[Design Input Document Control Matrix]]
!Attention points
Possible mechanisms to control input requirements include the following:
* A detailed [[Design Input Requirements Control Matrix]]
* Detailed input documents
|Symbol|Command|h
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|$\large \check{x}$|\\check{x}|
|$\large \dot{x}$|\\dot{x}|
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|$\large \acute{x}$|\\acute{x}|
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|$\large \grave{x}$|\\grave{x}|
|$\large \tilde{x}$|\\tilde{x}|
|$\large \bar{x}$|\\bar{x}|
|$\large \vec{x}$|\\vec{x}|
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Design Validation//'' means establishing objective evidence that device specifications conform with the user need(s) and intented use.

See also [[Software Validation]] which is part of design validation.
Premarket approval ([[PMA]]) is a process by which [[Class II Medical Devices]] are approved to enter into interstate commerce. Typically, a PMA requires detailed labelling identifying the intended use of the device, clinical and nonclincial studies documenting safety and effectiveness, and a detailed summary of the medical device's design, development, verification, validation, manufacturing and distribution.
/***
|''Name:''|FieldsEditorPlugin|
|''Description:''|//create//, //edit//, //view// and //delete// commands in toolbar <<toolbar fields>>.|
|''Version:''|1.0.2|
|''Date:''|Dec 21,2007|
|''Source:''|http://visualtw.ouvaton.org/VisualTW.html|
|''Author:''|Pascal Collin|
|''License:''|[[BSD open source license|License]]|
|''~CoreVersion:''|2.2.0|
|''Browser:''|Firefox 2.0; InternetExplorer 6.0, others|
!Demo:
On [[homepage|http://visualtw.ouvaton.org/VisualTW.html]], see [[FieldEditor example]]
!Installation:
*import this tiddler from [[homepage|http://visualtw.ouvaton.org/VisualTW.html]] (tagged as systemConfig)
*save and reload
*optionnaly : add the following css text in your StyleSheet : {{{#popup tr.fieldTableRow td {padding:1px 3px 1px 3px;}}}}
!Code
***/

//{{{

config.commands.fields.handlePopup = function(popup,title) {
	var tiddler = store.fetchTiddler(title);
	if(!tiddler)
		return;
	var fields = {};
	store.forEachField(tiddler,function(tiddler,fieldName,value) {fields[fieldName] = value;},true);
	var items = [];
	for(var t in fields) {
		var editCommand = "<<untiddledCall editFieldDialog "+escape(title)+" "+escape(t)+">>";
		var deleteCommand = "<<untiddledCall deleteField "+escape(title)+" "+escape(t)+">>";
		var renameCommand = "<<untiddledCall renameField "+escape(title)+" "+escape(t)+">>";
		items.push({field: t,value: fields[t], actions: editCommand+renameCommand+deleteCommand});
	}
	items.sort(function(a,b) {return a.field < b.field ? -1 : (a.field == b.field ? 0 : +1);});
	var createNewCommand = "<<untiddledCall createField "+escape(title)+">>";
	items.push({field : "", value : "", actions:createNewCommand });
	if(items.length > 0)
		ListView.create(popup,items,this.listViewTemplate);
	else
		createTiddlyElement(popup,"div",null,null,this.emptyText);
}

config.commands.fields.listViewTemplate = {
	columns: [
		{name: 'Field', field: 'field', title: "Field", type: 'String'},
		{name: 'Actions', field: 'actions', title: "Actions", type: 'WikiText'},
		{name: 'Value', field: 'value', title: "Value", type: 'WikiText'}
	],
	rowClasses: [
			{className: 'fieldTableRow', field: 'actions'}
	],
	buttons: [	//can't use button for selected then delete, because click on checkbox will hide the popup
	]
}

config.macros.untiddledCall = {  // when called from listview, tiddler is unset, so we need to pass tiddler as parameter
	handler : function(place,macroName,params,wikifier,paramString) {
		var macroName = params.shift();
		if (macroName) var macro = config.macros[macroName];
		var title = params.shift();
		if (title) var tiddler = store.getTiddler(unescape(title));
		if (macro) macro.handler(place,macroName,params,wikifier,paramString,tiddler);		
	}
}

config.macros.deleteField = {
	handler : function(place,macroName,params,wikifier,paramString,tiddler) {
		if(!readOnly && params[0]) {
			fieldName = unescape(params[0]);
			var btn = createTiddlyButton(place,"delete", "delete "+fieldName,this.onClickDeleteField);
			btn.setAttribute("title",tiddler.title);
			btn.setAttribute("fieldName", fieldName);
		}
	},
	onClickDeleteField : function() {
		var title=this.getAttribute("title");
		var fieldName=this.getAttribute("fieldName");
		var tiddler = store.getTiddler(title);
		if (tiddler && fieldName && confirm("delete field " + fieldName+" from " + title +" tiddler ?")) {
			delete tiddler.fields[fieldName];
			store.saveTiddler(tiddler.title,tiddler.title,tiddler.text,tiddler.modifier,tiddler.modified,tiddler.tags,tiddler.fields);
			story.refreshTiddler(title,"ViewTemplate",true);
		}
		return false;
	}
}

config.macros.createField = {
	handler : function(place,macroName,params,wikifier,paramString,tiddler) {
		if(!readOnly) {
			var btn = createTiddlyButton(place,"create new", "create a new field",this.onClickCreateField);
			btn.setAttribute("title",tiddler.title);
		}
	},
	onClickCreateField : function() {
		var title=this.getAttribute("title");
		var tiddler = store.getTiddler(title);
		if (tiddler) {
			var fieldName = prompt("Field name","");
			if (store.getValue(tiddler,fieldName)) {
				window.alert("This field already exists.");
			}
			else if (fieldName) {
				var v = prompt("Field value","");
				tiddler.fields[fieldName]=v;
				store.saveTiddler(tiddler.title,tiddler.title,tiddler.text,tiddler.modifier,tiddler.modified,tiddler.tags,tiddler.fields);
				story.refreshTiddler(title,"ViewTemplate",true);
			}
		}
		return false;
	}
}

config.macros.editFieldDialog = {
	handler : function(place,macroName,params,wikifier,paramString,tiddler) {
		if(!readOnly && params[0]) {
			fieldName = unescape(params[0]);
			var btn = createTiddlyButton(place,"edit", "edit this field",this.onClickEditFieldDialog);
			btn.setAttribute("title",tiddler.title);
			btn.setAttribute("fieldName", fieldName);
		}
	},
	onClickEditFieldDialog : function() {
		var title=this.getAttribute("title");
		var tiddler = store.getTiddler(title);
		var fieldName=this.getAttribute("fieldName");
		if (tiddler && fieldName) {
			var value = tiddler.fields[fieldName];
			value = value ? value : "";
			var lines = value.match(/\n/mg);
			lines = lines ? true : false;
			if (!lines || confirm("This field contains more than one line. Only the first line will be kept if you edit it here. Proceed ?")) {
				var v = prompt("Field value",value);
				tiddler.fields[fieldName]=v;
				store.saveTiddler(tiddler.title,tiddler.title,tiddler.text,tiddler.modifier,tiddler.modified,tiddler.tags,tiddler.fields);
				story.refreshTiddler(title,"ViewTemplate",true);
			}
		}
		return false;
	}
}

config.macros.renameField = {
	handler : function(place,macroName,params,wikifier,paramString,tiddler) {
		if(!readOnly && params[0]) {
			fieldName = unescape(params[0]);
			var btn = createTiddlyButton(place,"rename", "rename "+fieldName,this.onClickRenameField);
			btn.setAttribute("title",tiddler.title);
			btn.setAttribute("fieldName", fieldName);
		}
	},
	onClickRenameField : function() {
		var title=this.getAttribute("title");
		var fieldName=this.getAttribute("fieldName");
		var tiddler = store.getTiddler(title);
		if (tiddler && fieldName) {
			var newName = prompt("Rename " + fieldName + " as ?", fieldName);
			if (newName) {
				tiddler.fields[newName]=tiddler.fields[fieldName];
				delete tiddler.fields[fieldName];
				store.saveTiddler(tiddler.title,tiddler.title,tiddler.text,tiddler.modifier,tiddler.modified,tiddler.tags,tiddler.fields);
				story.refreshTiddler(title,"ViewTemplate",true);
			}
		}
		return false;
	}
}

config.shadowTiddlers.StyleSheetFieldsEditor = "/*{{{*/\n";
config.shadowTiddlers.StyleSheetFieldsEditor += ".fieldTableRow td {padding : 1px 3px}\n";
config.shadowTiddlers.StyleSheetFieldsEditor += ".fieldTableRow .button {border:0; padding : 0 0.2em}\n";
config.shadowTiddlers.StyleSheetFieldsEditor +="/*}}}*/";
store.addNotification("StyleSheetFieldsEditor", refreshStyles);

//}}}
Manufacturing change control is usually implemented using a set of standardized procedures similar to the following:
* A change request identifies a design problem which the requester believes should be corrected
** It might be originated by a developer, manager, reviewer, marketing representative, user, customer, quality assurance representative, or production personnel
** Change requests are typically reviewed following the manufacturer’s prescribed review process, and the request might be rejected, deferred, or accepted.
* If a change request is accepted and corrective action is straightforward, a [[Change Order]] might be issued on the spot to implement the change.
* It may not be practical to immediately revise documents affected by a change order.  Instead, the common practice is to distribute and attach a copy of the change order to each controlled copy of the original document.
* Change control procedures should incorporate review and assessment of the impact of the design change on the design input requirements and intended uses. • A mechanism should be established to track all change requests and change orders to ensure proper disposition. 
* Change control procedures are usually administered by the document control staff
!Project size
* For a ''Small development project''
** an adequate process for managing change involves little more than documenting the design change, performing appropriate verification and validation, and keeping records of reviews. 
** The main objectives are ensuring that:
*** corrective actions are tracked to completion;
***  changes are implemented in such a manner that the original problem is resolved and no new problems are created; or if new problems are created, they are also tracked to resolution; and
***  design documentation is updated to accurately reflect the revised design.
* For projects involving ''more than two persons''
** Coordination and communication of design changes become vitally important.
** Manufacturers should take steps to avoid the common situation where, for example, Jon and Marie agree to a make a change but neglect to inform Pat of their decision.
** Medical device manufacturers are usually quite comfortable with the processes of document control and change control with respect to managing manufacturing documents.
These regulations implement the FDA's responsibilities and authority to require the recall of failed, defected, adulterated, or misbranded medical devices.

Based on FDA assessment, this regulation empowers the agency with significant powers to remove, through a variety of recall actions, devices the agency feels require removal from the marketplace.
<!--{{{-->
<div class='toolbar' macro='toolbar [[ToolbarCommands::ViewToolbar]] icons:yes more:popup'></div>
<div class='heading'>
	<div class='spaceSiteIcon' macro='tiddlerOrigin label:yes height:48 width:48'></div>
	<div class='modifierIcon'
		macro='view modifier SiteIcon label:yes height:48 width:48 labelPrefix:"modified by "'>
	</div>
	<div class='title' macro='view title'></div>
	<div class='tagClear'></div>
</div>
<div class='tagClear'></div>
<div class='concertina' ></div>
<div class='content'>
	<div class='info'>
		<div class='calendar' macro='viewRevisions page:5'>
			<div class='month' macro='view modified date mmm'></div>
			<div class='date' macro='view modified date 0DD'></div>
			<div class='time' macro='view modified date 0hh:0mm'></div>
		</div>
		<div class='tagClear'></div>
		<div class='tagged' macro='tags'></div>
	</div>
	<div class='viewer' macro='view text wikified'></div>
</div>
<div class='tagClear'></div>
<div class='tagging' macro='tagging'></div>
<div class='counted' macro='BBClonePlugin'></div>
<div class='tagClear'></div>
<!--}}}-->
/***
|''Name''|RevisionsCommandPlugin|
|''Description''|provides access to tiddler revisions|
|''Author''|FND|
|''Contributors''|Martin Budden|
|''Version''|0.3.2|
|''Status''|@@beta@@|
|''Source''|http://svn.tiddlywiki.org/Trunk/association/plugins/RevisionsCommandPlugin.js|
|''CodeRepository''|http://svn.tiddlywiki.org/Trunk/association/plugins/|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''CoreVersion''|2.6.0|
|''Keywords''|serverSide|
!Usage
Extend [[ToolbarCommands]] with {{{revisions}}}.
!Revision History
!!v0.1 (2009-07-23)
* initial release (renamed from experimental ServerCommandsPlugin)
!!v0.2 (2010-03-04)
* suppressed wikification in diff view
!!v0.3 (2010-04-07)
* restored wikification in diff view
* added link to side-by-side diff view
!To Do
* strip server.* fields from revision tiddlers
* resolve naming conflicts
* i18n, l10n
* code sanitizing
* documentation
!Code
***/
//{{{
(function($) {

jQuery.twStylesheet(".diff { white-space: pre, font-family: monospace }",
	{ id: "diff" });

var cmd = config.commands.revisions = {
	type: "popup",
	hideShadow: true,
	text: "revisions",
	tooltip: "display tiddler revisions",
	revTooltip: "", // TODO: populate dynamically?
	loadLabel: "loading...",
	loadTooltip: "loading revision list",
	selectLabel: "select",
	selectTooltip: "select revision for comparison",
	selectedLabel: "selected",
	compareLabel: "compare",
	linkLabel: "side-by-side view",
	revSuffix: " [rev. #%0]",
	diffSuffix: " [diff: #%0 #%1]",
	dateFormat: "YYYY-0MM-0DD 0hh:0mm",
	listError: "revisions could not be retrieved",

	handlePopup: function(popup, title) {
		stripSuffix = function(type, title) {
			var str = cmd[type + "Suffix"];
			var i = str.indexOf("%0");
			i = title.indexOf(str.substr(0, i));
			if(i != -1) {
				title = title.substr(0, i);
			}
			return title;
		};
		title = stripSuffix("rev", title);
		title = stripSuffix("diff", title);
		var tiddler = store.getTiddler(title);
		var type = this._getField("server.type", tiddler);
		var adaptor = new config.adaptors[type]();
		var limit = null; // TODO: customizable
		var context = {
			host: this._getField("server.host", tiddler),
			workspace: this._getField("server.workspace", tiddler)
		};
		var loading = createTiddlyButton(popup, cmd.loadLabel, cmd.loadTooltip);
		var params = { popup: popup, loading: loading, origin: title };
		adaptor.getTiddlerRevisionList(title, limit, context, params, this.displayRevisions);
	},

	displayRevisions: function(context, userParams) {
		removeNode(userParams.loading);
		if(context.status) {
			var callback = function(ev) {
				var e = ev || window.event;
				var revision = resolveTarget(e).getAttribute("revision");
				context.adaptor.getTiddlerRevision(tiddler.title, revision, context,
					userParams, cmd.displayTiddlerRevision);
			};
			var table = createTiddlyElement(userParams.popup, "table");
			for(var i = 0; i < context.revisions.length; i++) {
				var tiddler = context.revisions[i];
				var row = createTiddlyElement(table, "tr");
				var timestamp = tiddler.modified.formatString(cmd.dateFormat);
				var revision = tiddler.fields["server.page.revision"];
				var cell = createTiddlyElement(row, "td");
				createTiddlyButton(cell, timestamp, cmd.revTooltip, callback, null,
					null, null, { revision: revision });
				cell = createTiddlyElement(row, "td", null, null, tiddler.modifier);
				cell = createTiddlyElement(row, "td");
				createTiddlyButton(cell, cmd.selectLabel, cmd.selectTooltip,
					cmd.revisionSelected, null, null, null,
					{ index:i, revision: revision, col: 2 });
				cmd.context = context; // XXX: unsafe (singleton)!?
			}
		} else {
			$("<li />").text(cmd.listError).appendTo(userParams.popup);
		}
	},

	revisionSelected: function(ev) {
		var e = ev || window.event;
		e.cancelBubble = true;
		if(e.stopPropagation) {
			e.stopPropagation();
		}
		var n = resolveTarget(e);
		var index = n.getAttribute("index");
		var col = n.getAttribute("col");
		while(!index || !col) {
			n = n.parentNode;
			index = n.getAttribute("index");
			col = n.getAttribute("col");
		}
		cmd.revision = n.getAttribute("revision");
		var table = n.parentNode.parentNode.parentNode;
		var rows = table.childNodes;
		for(var i = 0; i < rows.length; i++) {
			var c = rows[i].childNodes[col].firstChild;
			if(i == index) {
				if(c.textContent) {
					c.textContent = cmd.selectedLabel;
				} else {
					c.text = cmd.selectedLabel;
				}
			} else {
				if(c.textContent) {
					c.textContent = cmd.compareLabel;
				} else {
					c.text = cmd.compareLabel;
				}
				c.onclick = cmd.compareSelected;
			}
		}
	},

	compareSelected: function(ev) {
		var e = ev || window.event;
		var n = resolveTarget(e);
		var context = cmd.context;
		context.rev1 = n.getAttribute("revision");
		context.rev2 = cmd.revision;
		context.tiddler = context.revisions[n.getAttribute("index")];
		context.format = "unified";
		context.adaptor.getTiddlerDiff(context.tiddler.title, context,
			context.userParams, cmd.displayTiddlerDiffs);
	},

	displayTiddlerDiffs: function(context, userParams) {
		var tiddler = context.tiddler;
		tiddler.title += cmd.diffSuffix.format([context.rev1, context.rev2]);
		tiddler.text = "{{diff{\n" + context.diff + "\n}}}";
		tiddler.tags = ["diff"];
		tiddler.fields.doNotSave = "true"; // XXX: correct?
		if(!store.getTiddler(tiddler.title)) {
			store.addTiddler(tiddler);
		}
		var src = story.getTiddler(userParams.origin);
		var tiddlerEl = story.displayTiddler(src, tiddler);
		var uri = context.uri.replace("format=unified", "format=horizontal");
		var link = $('<a target="_blank" />').attr("href", uri).text(cmd.linkLabel);
		$(".viewer", tiddlerEl).prepend(link);
	},

	displayTiddlerRevision: function(context, userParams) {
		var tiddler = context.tiddler;
		tiddler.title += cmd.revSuffix.format([tiddler.fields["server.page.revision"]]);
		tiddler.fields.doNotSave = "true"; // XXX: correct?
		if(!store.getTiddler(tiddler.title)) {
			store.addTiddler(tiddler);
		}
		var src = story.getTiddler(userParams.origin);
		story.displayTiddler(src, tiddler);
	},

	_getField: function(name, tiddler) {
		return tiddler.fields[name] || config.defaultCustomFields[name];
	}
};

})(jQuery);
//}}}
''5.6.1 General''

Top management shall review the organization’s quality management system, at ''planned intervals'', to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews shall be maintained (see [[4.2.4 Control of records|ISO13485 - 4.2.4 Control of records]]).
//(f) Indication of potential and current//
During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).

NOTE Customer property can include intellectual property or confidential health information.
/***
|''Name''|BinaryTiddlersPlugin|
|''Description''|renders base64-encoded binary tiddlers as images or links|
|''Author''|FND|
|''Version''|0.3.0|
|''Status''|@@beta@@|
|''Source''|http://svn.tiddlywiki.org/Trunk/association/plugins/BinaryTiddlersPlugin.js|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''CoreVersion''|2.5|
!Code
***/
//{{{
(function($) {

var ctfield = "server.content-type";

var plugin = config.extensions.BinaryTiddlersPlugin = {
	isWikiText: function(tiddler) {
		var ctype = tiddler.fields[ctfield];
		if(ctype) {
			return !this.isBinary(tiddler) && !this.isTextual(ctype);
		} else {
			return true;
		}
	},
	// NB: pseudo-binaries are considered non-binary here
	isBinary: function(tiddler) {
		var ctype = tiddler.fields[ctfield];
		return ctype ? !this.isTextual(ctype) : false;
	},
	isTextual: function(ctype) {
		return ctype.indexOf("text/") == 0 || this.endsWith(ctype, "+xml");
	},
	endsWith: function(str, suffix) {
		return str.length >= suffix.length &&
			str.substr(str.length - suffix.length) == suffix;
	}
};

// hijack text viewer to add special handling for binary tiddlers
var _view = config.macros.view.views.wikified;
config.macros.view.views.wikified = function(value, place, params, wikifier,
		paramString, tiddler) {
	var ctype = tiddler.fields["server.content-type"];
	if(params[0] == "text" && ctype && !tiddler.tags.contains("systemConfig")) {
		var el;
		if(plugin.isBinary(tiddler)) {
			var uri = "data:%0;base64,%1".format([ctype, tiddler.text]); // TODO: fallback for legacy browsers
			if(ctype.indexOf("image/") == 0) {
				el = $("<img />").attr("alt", tiddler.title).attr("src", uri);
			} else {
				el = $("<a />").attr("href", uri).text(tiddler.title);
			}
		} else {
			el = $("<pre />").text(tiddler.text);
		}
		el.appendTo(place);
	} else {
		_view.apply(this, arguments);
	}
};

// hijack edit macro to disable editing of binary tiddlers' body
var _editHandler = config.macros.edit.handler;
config.macros.edit.handler = function(place, macroName, params, wikifier,
		paramString, tiddler) {
	if(params[0] == "text" && plugin.isBinary(tiddler)) {
		return false;
	} else {
		_editHandler.apply(this, arguments);
	}
};

// hijack autoLinkWikiWords to ignore binary tiddlers
var _autoLink = Tiddler.prototype.autoLinkWikiWords;
Tiddler.prototype.autoLinkWikiWords = function() {
	return plugin.isWikiText(this) ? _autoLink.apply(this, arguments) : false;
};

})(jQuery);
//}}}
/***
|''Name''|GraphPlugin|
|''Description''|Display dot graphs|
|''Version''|0.12.1|
|''Status''|beta|
|''License''|[[BSD open source license]] from [[IDEIA|http://www.ideia.fr]]|
|''~CoreVersion''|2.4.0|
|''Keywords''|visualization, graph, diagram, forcedirected, animated|
!Usage
Draw a graph
{{{
<<graph dimX dimY nolinks backlinks strict tags:tags anim:timing filter:tags start:tiddlers plot:tiddler>>
}}}
Options
* ''nolinks''  : do not follow forward links and tags
* ''nogroups'' : do not treat "tag" links as group links
* ''backlinks'' : follow reverse links
* ''strict'' : exclude all node not tagged with "tags" (otherwise direct links are included)
* ''notags'' : ignore tag links
* ''fields'' : read from fields instead of slices
* ''anim'':animate graph for some time
* ''tags'' : choose tiddlers with specified tags
* ''filter'' : exclude those tiddler with specified tags
* ''start'' : check also from these tiddler (+ thier direct links)
* ''plot'' : use the text of this tiddler to draw a graph from the text and not the tiddlers node, annot, link, type in an array. '->' for direct link, '<-' for backlinks and ':>' or ':<' for tag/group link.
Change node properties with slices
* ''color'' : graph.fillStyle, graph.strokeStyle, 
* ''position'' : graph.X, graph.Y, graph.repulse
* ''display'': graph.title, graph.subTitle, graph.ignore
* ''life'' : graph.endLife, graph.startLife
In GraphConfig, you can configure style for links by combining
* ''link type'': direct, titled, bracket, back, tag
* ''display'' : fillStyle, strokeStyle, lineWidth, margin, rounded
!!History
|15.01.09| 0.1.0|Initial release, draw graph with anotated nodes from tiddler|
|16.01.09| 0.2.0|Add animation (the 3 parameter is the number of steps calculated)|
|19.01.09| 0.3.0|Added ability to move nodes, graph dynamically updated|
|22.01.09| 0.4.0|Support of multiple tags and filter also|
|22.01.09| 0.5.0|Can set color for node and links, depending of it's type|
|23.01.09| 0.6.0|Annotated links can be overiden by a tiddler|
|23.01.09| 0.6.1|Fix a bug : now start can have multiple tiddlers|
|23.01.09| 0.7.0|Now a new slice graph.subtitle|
|28.01.09| 0.8.0|Add preliminary time support in graph : graph.endLife|
|02.02.09| 0.8.1|Add "strict" filter for some graph displaying unwanted nodes|
|03.02.09| 0.8.2|Add graph.ignore to filter some individual links in graph|
|04.02.09| 0.8.3|Initial position of node is not 0 any more, so that no more random graphs|
|04.02.09| 0.9.0|Option to read from slices or from fields|
|05.02.09| 0.9.1|Add : graph.startLife|
|05.02.09| 0.9.2|Add : graph.repulse : so that nodes can be more isolated (useful for anotated links|
|13.02.09| 0.9.3|Links can be individually colored in their tiddler if it exist, rather than in GraphConfig|
|20.02.09| 0.10.0|Add : rounded rectangle + collapsible text for links|
|13.04.09| 0.11.0|Add direct graph plotting from table syntax|
|13.04.09| 0.12.0|Add group node support (eq tag link = group link)|
|13.04.09| 0.12.0|Add 'dot' syntax to direct graph (it means that it can read plain text to draw graphs|
!Known BUGS
* In some cases when every node in the graph have exactly the same tags, it can create a NaN anomaly. To bypass it, just change some tags.
* the new functionnalité collapsible links is not yet compatible with "full links" ... full links are links described in a tiddler
!Code
***/
//{{{
if(!version.extensions.GraphPlugin) {
version.extensions.GraphPlugin = {installed:true};

config.macros.graph = {};

config.macros.graph.handler = function(place,macroName,params,wikifier,paramString,tiddler)
{
	var box = createTiddlyElement(place,"div",null,"graphBox",'');
	box.title = "Graph";
	box.id = "graphBox";
	box.style.position = "relative";
	var canvas = document.createElement("canvas");
	canvas.width = params[0];
	canvas.height = params[1];
	box.appendChild(canvas);
	var ctx = canvas.getContext("2d");
	var timer = document.createElement("div");
	box.appendChild(timer);

	var parameters = paramString.parseParams("noname",null,true);
	var includeTags = parameters[0]["tags"]?parameters[0]["tags"][0].split(","):[];
	var startTiddlers = parameters[0]["start"]?parameters[0]["start"][0].split(","):[];
	var plotTiddlers = parameters[0]["plot"]?parameters[0]["plot"][0].split(","):[];
	var excludeTags = parameters[0]["filter"]?parameters[0]["filter"][0].split(","):[];
	var anim = parameters[0]["anim"]?parseInt(parameters[0]["anim"][0]):0;
	var results = [];
	if (parameters[0]["start"]) {
		for (var k=0; k<startTiddlers.length; k++)
			results.push( store.getTiddler(startTiddlers[k]) );
	} else store.forEachTiddler(function(title,tiddler) {
		if (tiddler.tags.containsAny(includeTags) 
		 && !tiddler.tags.containsAny(excludeTags))
			results.push(tiddler);
		});

var g = new Graph(box);
g.useSlice = parameters[0]["noname"].indexOf("fields") == -1;
g.useGroup = parameters[0]["noname"].indexOf("nogroups") == -1;
var strict = parameters[0]["noname"].indexOf("strict") != -1;
var waitingList = [];
var time=0;

	if (parameters[0]["plot"]) {
		for (var k=0; k<plotTiddlers.length; k++)
			plotTiddler( store.getTiddler(plotTiddlers[k]) );
	}

for (var i=0; i<results.length; i++)
{
	if (!g.getValue(results[i].title, "graph.startLife"))
		g.addNode(results[i].title); 
	else
		waitingList.push(results[i]);
}
relink();

function plotGetTableLine(line) {
     params = line.split('|');
     node = params[1];
     if (!node) return;
     annot = params[2];
     link = params[3];
     linktype = params[4]?params[4]:"plot";
     if (link)
       g.addEdge(node, link,{type:linktype, text:annot?annot:""})
     else
       g.addNode(node, annot); 
}

function plotGetWikiLinks(node, line, mode) {
        // mode = 0 : direct link, mode = 1 : backlink, mode = 2, group link
	node = node.replace(/ /g,'').replace(/^\*/g, '').replace(/\'/g, '').replace(/\[/g,'').replace(/\]/g,'');
	var tiddlerLinkRegExp = config.textPrimitives.tiddlerForcedLinkRegExp;
        t=1;
function addInternalLink(link, annot) {
               switch (mode) {
                       case '->' : g.addEdge(node, link,{type:"plot", text:annot}); break;
                       case '<-' : g.addEdge(link, node,{type:"plot", text:annot}); break;
                       case ':>' : g.addEdge(node, link,{type:"tag", text:annot}); break;
                       case ':<' : g.addEdge(link, node,{type:"tag", text:annot}); break;
              }
}

	//tiddlerLinkRegExp.lastIndex = 0;
	var formatMatch = tiddlerLinkRegExp.exec(line);
	while(formatMatch) {
		//var lastIndex = tiddlerLinkRegExp.lastIndex;
		if(formatMatch[2-t] && !config.formatterHelpers.isExternalLink(formatMatch[3-t])) // titledBrackettedLink
                        addInternalLink(formatMatch[3-t], formatMatch[2-t], node, mode)
		else if(formatMatch[4-t] && formatMatch[4-t] != this.title) // brackettedLink
			addInternalLink(formatMatch[4-t], "", node, mode);
		//tiddlerLinkRegExp.lastIndex = lastIndex;
		formatMatch = tiddlerLinkRegExp.exec(line);
	}

}

function plotTiddler(tiddler) {
  var lines = new Array();   
  lines = tiddler.text.split("\n");
  for (var i=0; i < lines.length; i++) {
    var line = lines[i]; 
    if (line == "") continue;
    if (line[0] == "|") plotGetTableLine(line);
    var n = line.indexOf("->");
    if (n != -1) plotGetWikiLinks(line.slice(0, n), line.slice(n+2), '->');
    n = line.indexOf("<-");
    if (n != -1) plotGetWikiLinks(line.slice(0, n), line.slice(n+2), '<-');
    n = line.indexOf(":>");
    if (n != -1) plotGetWikiLinks(line.slice(0, n), line.slice(n+2), ':>');
    n = line.indexOf(":<");
    if (n != -1) plotGetWikiLinks(line.slice(0, n), line.slice(n+2), ':<');
  }
}

function relink() {
	for (var i=0; i<results.length; i++)
	{
		if (!g.getValue(results[i].title, "graph.startLife"))
			addLinks(results[i]); 
	}
}

function tiddlerIndexOf(a, t) {
	for (var i=0; i<a.length; i++)
		if (a[i].title == t) return i;
	return -1;
}

function addLivingEdge(ta, tb, info) {
	if (!g.getValue(tb, "graph.startLife") )
		g.addEdge(ta, tb, info);
	else if (time >= g.getValue(tb, "graph.startLife" ))
		g.addEdge(ta, tb, info);
}

function addLinks(ta) {
	var ignoreList = g.getValue(ta.title, "graph.ignore");
	ignoreList = ignoreList ? ignoreList.readBracketedList():[];

	if (parameters[0]["noname"].indexOf("notags") == -1) {
		for (var j=0; j<results.length; j++)  {
			var tb = results[j];
			if (ignoreList.contains(tb.title)) continue;
			if ( ta.tags.contains(tb.title) ) 
			addLivingEdge(ta.title, tb.title, {type:"tag", text:""});
		}
	}
	if (parameters[0]["noname"].indexOf("backlinks") != -1) {
		var references = store.getReferringTiddlers(ta.title);
		for(var r=0; r<references.length; r++) {
			if(references[r].title != ta.title
			 && !references[r].tags.contains("excludeLists")
			 && (tiddlerIndexOf(results, references[r].title) != -1 || !strict) 
			 && (!ignoreList.contains(references[r].title)) )
				addLivingEdge(ta.title, references[r].title, {type:"back", text:""});
		}
	}
	if (parameters[0]["noname"].indexOf("nolinks") == -1) {
		var links = ta.annotatedLinks();
		for (var r=0; r<links.length; r++) {
			if ( (tiddlerIndexOf(results, links[r].link) != -1 || !strict)
			 && !ignoreList.contains(links[r].link))
				addLivingEdge(ta.title, links[r].link, links[r].info);
		}
	}

}

var layouter = new Graph.Layout.Spring(g);
layouter.prepare();
var renderer = new Graph.Renderer.Basic(canvas, g);
var interval = 0; 
if (anim != 0)
	interval = setInterval(animate, 250);
else
{
	layouter.layout();
	renderer.draw();
}

function animate()
{
	timer.innerHTML = "time :"+time;
	if (isdrag) {
		elementToMove.style.left = newElementX + 'px';
		elementToMove.style.top  = newElementY + 'px';
		layouter.reverse(renderer.factorX, renderer.factorY);
	}
	for (var i=waitingList.length-1; i>=0; i--) {
		var current = waitingList[i];
		if (time >= g.getValue(current.title, "graph.startLife")) {
			g.addNode(current.title);
			relink();
			layouter.layoutPrepareLastNode();
			waitingList.splice(i,1);
		}
	}
	g.animate(time);
	layouter.step();
	renderer.draw();
	time++;
	if (time==anim || time > 500) clearInterval(interval);
}


var ie=document.all;
var nn6=document.getElementById&&!document.all;
var isdrag=false;					// this flag indicates that the mouse movement is actually a drag.
var mouseStartX, mouseStartY;		// mouse position when drag starts
var elementStartX, elementStartY;	// element position when drag starts
var newElementX, newElementY;
var elementToMove;
var bounds = new Array(4);

function movemouse(e)
{
	if (isdrag)
	{
		var currentMouseX = nn6 ? e.clientX : event.clientX;
		var currentMouseY = nn6 ? e.clientY : event.clientY;
		newElementX = elementStartX + currentMouseX - mouseStartX;
		newElementY = elementStartY + currentMouseY - mouseStartY;

		/*/ check bounds
		// note: the "-1" and "+1" is to avoid borders overlap
		if(newElementX < bounds[0])
			newElementX = bounds[0] + 1;
		if(newElementX + elementToMove.offsetWidth > bounds[2])
			newElementX = bounds[2] - elementToMove.offsetWidth - 1;
		if(newElementY < bounds[1])
			newElementY = bounds[1] + 1;
		if(newElementY + elementToMove.offsetHeight > bounds[3])
			newElementY = bounds[3] - elementToMove.offsetHeight - 1;*/
		
		// move element
		elementToMove.style.left = newElementX + 'px';
		elementToMove.style.top  = newElementY + 'px';
	
		elementToMove.style.right = null;
		elementToMove.style.bottom = null;

		layouter.reverse(renderer.factorX, renderer.factorY);
		
		return false;
	}
}

function startDrag(e) 
{	
	var eventSource = nn6 ? e.target : event.srcElement;
	if(eventSource.tagName == 'HTML')
		return;

	while (eventSource != document.body && !hasClass(eventSource, "draggable"))
	{  	
		eventSource = nn6 ? eventSource.parentNode : eventSource.parentElement;
	}

	// if a draggable element was found, calculate its actual position
	if (hasClass(eventSource, "draggable"))
	{
                time = 0;
		isdrag = true;
		elementToMove = eventSource;

		// set absolute positioning on the element		
		//elementToMove.style.position = "absolute";
				
		// calculate start point
		elementStartX = elementToMove.offsetLeft;
		elementStartY = elementToMove.offsetTop;
		
		// calculate mouse start point
		mouseStartX = nn6 ? e.clientX : event.clientX;
		mouseStartY = nn6 ? e.clientY : event.clientY;
		
		/*/ calculate bounds as left, top, width, height of the parent element
		if(getStyle(elementToMove.parentNode, "position") == 'absolute')
		{
			bounds[0] = 0;
			bounds[1] = 0;
		}
		else
		{
			bounds[0] = calculateOffsetLeft(elementToMove.parentNode);
			bounds[1] = calculateOffsetTop(elementToMove.parentNode);
		}
		bounds[2] = bounds[0] + elementToMove.parentNode.offsetWidth;
		bounds[3] = bounds[1] + elementToMove.parentNode.offsetHeight;*/
		
		document.onmousemove = movemouse;
		interval = setInterval(animate, 50);
				
		return false;
	}
}

function stopDrag(e)
{
	isdrag=false; 
	elementToMove = null;
	document.onmousemove = null;
	clearInterval(interval);
	animate(); // one last time to refresh correctly last mouse pos
}

document.onmousedown = startDrag;
document.onmouseup = stopDrag;


function hasClass(element, className)
{
	if(!element || !element.className)
		return false;
		
	var classes = element.className.split(' ');
	var i;
	for(i = 0; i < classes.length; i++)
		if(classes[i] == className)
			return true;
	return false;
}

function getStyle(node, styleProp)
{
	// if not an element
	if( node.nodeType != 1)
		return;
		
	var value;
	if (node.currentStyle)
	{
		// ie case
		styleProp = replaceDashWithCamelNotation(styleProp);
		value = node.currentStyle[styleProp];
	}
	else if (window.getComputedStyle)
	{
		// mozilla case
		value = document.defaultView.getComputedStyle(node, null).getPropertyValue(styleProp);
	}
	
	return value;
}

function replaceDashWithCamelNotation(value)
{
	var pos = value.indexOf('-');
	while(pos > 0 && value.length > pos + 1)
	{
		value = value.substring(0, pos) + value.substring(pos + 1, pos + 2).toUpperCase() + value.substring(pos + 2);
		pos = value.indexOf('-');
	}
	return value;
}

/*
 * This function calculates the absolute 'top' value for a html node
 */
function calculateOffsetTop(obj)
{
	var curtop = 0;
	if (obj.offsetParent)
	{
		curtop = obj.offsetTop
		while (obj = obj.offsetParent) 
			curtop += obj.offsetTop
	}
	else if (obj.y)
		curtop += obj.y;
	return curtop;
}

/*
 * This function calculates the absolute 'left' value for a html node
 */
function calculateOffsetLeft(obj)
{
	var curleft = 0;
	if (obj.offsetParent)
	{
		curleft = obj.offsetLeft
		while (obj = obj.offsetParent) 
		{
			curleft += obj.offsetLeft;
		}
	}
	else if (obj.x)
		curleft += obj.x;
	return curleft;
}



}
}


//}}}
Unless you're delighted with the default theme you can make some quick changes by generating a new random color palette, hit this button to cycle through some alternatives.

<<RandomColorPaletteButton saturation_pale:0.67 saturation_light:0.53
saturation_mid:0.43 saturation_dark:0.06 pale:0.99 light:0.85 mid:0.5 dark:0.31>>

You can also change the look and feel completely by installing a new theme. To do this, find one you like in the @themes space, note down the name, and include it in this space by going to the space menu. You can reach the space menu by clicking on the blue and pink circle at the top-right of the page and chooshing "THIS SPACE". Here are a few to check out:
* @pip
* @caspian-ii
* @basalt
* @simplicity
* @cheesecake
* @jelly-doughnut

(//Note that if you are using a custom TiddlySpace install, these themes may not be present.//)
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EN is a European Standard published by European Commision for Standardization
''Clause 1 Scope''

1.1 General
* Demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory
requirements applicable to medical devices and related services.
1.2 Application
* Possible exclusion of clause 7.3 (design & development)
* Possible non applicable of parts of clause 7
* Both must be justified in quality manual
* Examples: 7.5.1.2.1 (cleanliness), 7.5.1.3 & 7.5.2.2 (sterile); 7.5.3.2.2 (implant)
* Question: what about section 8.2.4.2 (implant)?

“Appropriate” Term
There are a lot of interesting people using ~TiddlySpace that you might like to keep track of and interact with. There are a number of ways of doing this.

If you see a number in the speech bubble in one of your tiddlers, it means that someone is writing about the same thing as you. You can find out what they're saying by clicking on it. Likewise, if you see something interesting in someone else's space, you can respond to it and write up your own thoughts on the subject by clicking "Reply to this tiddler".

Additionally, if you find anyone interesting, or you find an interesting looking space and you'd like to know when it's changed, you can "follow" that space. To do this, simply create a tiddler with the title: {{{@space-name}}} and tag it {{{follow}}}. If you want, you can store some notes about that space in the body of the tiddler.

If you then want to know what happening, simply [[include|How do I include/exclude spaces?]]@docs the @tivity space and then visit your activity stream at [[/activity|/activity]], or just visit the @tapas space directly.

!Not sure who to follow?
Here's a few suggestions:
* @fnd
* @cdent
* @pmario
* @bengillies
* @dickon
In the FDA [[Design Controls]] ''//Document Control//'' is the enumeration of design documents, and tracking their status and revision history.  Throughout this section, the term “document” is used in an inclusive sense to mean all design documents, drawings, and other items of design input or output which characterize the design or some aspect of it.

The features of a manufacturing document control system typically include the following:
* Documents should be identified (i.e., named and numbered) in accordance with some logical scheme which links the documents to the product or component they describe or depict and illuminates the drawing hierarchy. 
* A master list or index of documents should be maintained which presents a comprehensive overview of the documentation which collectively defines the product and/or process.
* Approval procedures should be prescribed which govern entry of documents into the document control system.
* A history of document revisions should be maintained.
* Procedures for distributing copies of controlled documents and tracking their location should be prescribed.
* Files of controlled documents should be periodically inventoried to ensure that the contents are up to date.
* A person or persons should be assigned specific responsibility to oversee and carry out these procedures.
** It is desirable that the document control system be administered by a person who is not directly involved with developing or using the documents.
** For a small manufacturer, document control might be a part-time job for a technician or clerical staff person.  More typically, one or more librarians or full-time clerical or paraprofessional employees are required to administer the system.
* There should be a procedure for removal and deletion of obsolete documents
/*{{{*/
body {
	font-size: 1em;
	font-family: helvetica, arial, sans-serif;
	background-color: #fff;
	color: [[ColorPalette::Foreground]];
}

body ul { margin: 0; }

#popup {
	background-color: [[ColorPalette::TertiaryPale]];
}

#popup.confirmationPopup, .followList {
	font-size: 0.8em;
	padding: 1em;
	border: solid 1px [[ColorPalette::SecondaryMid]];
	background-color: [[ColorPalette::SecondaryPale]];
}

.followList .listTitle {
	text-decoration: underline;
}

#popup .followTiddlersList a {
	display: inline;
	padding: 0;
}

.viewer td { vertical-align: top; }

.borderless table,
.borderless th,
.borderless tr,
.borderless td
   { border:0 }

#popup li a {
	color: #fff;
	font-weight: bold;
}

#popup li a:hover {
	color: #fff;
	background: [[ColorPalette::PrimaryMid]];
}

#popup li.listTitle {
	border-bottom: 1px solid #000;
	font-weight: bold;
	margin-bottom: 10px;
}

#displayArea {
	margin: 0;
	top: 0px;
	left: 0px;
	width: 100%;
	position: relative;
}

.public {
	border-color: #C7EAFF;
}

.private {
	border-color: #FFCAE9;
}

/* *** Header *** */

.headerFix{
	background: [[ColorPalette::PrimaryMid]];
	_width: 100%; /* for ie 6 */
}
.header{
	color: #fff;
	background: [[ColorPalette::PrimaryMid]];
	overflow: hidden;
	_width: 100%; /* for ie 6 */
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.clearFloat {
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#jsMath_Warning {display: none}

#contentWrapper {
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	padding-top: 1px;
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#tiddlerDisplay {
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#sidebarSearch {
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	right: 80px;
	top: 8px;
	width: 176px;
}

#sidebarSearch .txtOptionInput {
	width: 100%;
	margin-top: 5px;
	_color: #bbb; /* ie6 danger */
}

#sidebarSearch .txtOptionInput:focus {
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#sidebarSearch .searchButton {
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}

/* *** Menu Bar *** */

#mainMenu {
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	text-align: left;
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	min-height: 1em;
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#sidebarOptions a {
	margin-right: 8px;
}

#mainMenu a:hover {
	background-color: [[ColorPalette::PrimaryMid]];
	color: [[ColorPalette::Background]]
}

.confirmationPopup .button,
#sidebarOptions .button {
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	line-height: 1.4em;
	text-align: center;
	margin-right: 8px;
	margin-left:-2px;
}

.confirmationPopup .button {
	font-size: 0.9em;
	padding: 2px;
}

#sidebarOptions .button {
	font-size: 0.7em;
	float: left;
	width: 80px;
	padding: 0px;
}

.confirmationPopup a.button,
#sidebarOptions a {
	border: none;
	margin: 0 0.2em;
	padding: 0.6em 0.25em;
	display: inline;
	color: #666;
}

.confirmationPopup a.button:hover,
#sidebarOptions a:hover {
	color: #000;
}

.confirmationPopup a.button:active,
#sidebarOptions a:active {
	border: solid 1px [[ColorPalette::PrimaryMid]];
	background-color: #fff;
	background: -webkit-gradient( linear, left bottom, left top, color-stop(0.1,rgb(200,200,200)), color-stop(1, rgb(100,100,100)));
	background: -moz-linear-gradient(center bottom , rgb(200,200,200) 10%,rgb(100,100,100) 100%) repeat scroll 0 0 transparent;
}
/* *** Sidebar *** */

#sidebar .wizard table {
	margin: 0px;
}

.tabContents .listTitle:first-child {
	margin-top: 0px;
}

/*******************/
/* --- New CSS --- */
/*******************/

#menuBar {
	background: [[ColorPalette::PrimaryLight]];
	left: 0;
	right: 0;
	position: relative;
	margin: 0;
	padding: 0.5em 0 0.5em 0;
	min-height: 1em;
	overflow: hidden;
	_width: 100%; /* for ie 6 */
}


#menuBarOptions {
	background: [[ColorPalette::PrimaryPale]];
	left: 0;
	right: 0;
	position: relative;
	margin: 0;
	overflow: hidden;
	_width: 100%; /* for ie 6 */
}


#mainMenu a {
	color: #fff;
	padding: 8px;T
	font-size: 0.9em;
	margin-right: 16px;
}

#sidebarOptions a.button {
	color: #fff;
}

#sidebarOptions a.button:hover {
	color: [[ColorPalette::PrimaryPale]];
    background: [[ColorPalette::PrimaryMid]];
}

#tiddlerDisplay, #searchResults {
	margin: 16px 260px 0 40px;
}

#sidebarTabs {
	font-size: 0.7em;
	position: absolute;
	right: 22px;
	width: 208px;
	top: 0;
	font-size: 0.7em;
}

#sidebarTabs .tabsetWrapper .tabset {
	font-size: 0.7em;
	border-top: 1px solid [[ColorPalette::PrimaryPale]];
	border-left: 1px solid [[ColorPalette::PrimaryPale]];
	border-bottom: 1px solid [[ColorPalette::PrimaryPale]];
	height: auto;
	float: left;
	word-wrap: break-word;
	top: 0;
	padding: 0;
}

#sidebarTabs .tabsetWrapper .tabContents {
	font-size: 0.7em;
	background-color: [[ColorPalette::PrimaryPale]];
	border: 3px solid [[ColorPalette::PrimaryMid]];
	width: 160px;
	_width: 156px;
	left: -3px;
	_left: -5px;
	position: relative;
	min-height: 34em;
	padding: 8px;
}

/* ---- Side style --- */

#sidebarTabs .tabsetWrapper .tabset .tab {
	font-size: 0.7em;
	padding: 0.7em 8px 0.5em;
	color: #fff;
	background: [[ColorPalette::PrimaryLight]];
	border: none;
	line-height: 16px;
	position: relative;
	display: block;
	margin: 0;
}

#sidebarTabs .tabsetWrapper .tabset .tabSelected {
	font-size: 0.7em;
	color: [[ColorPalette::PrimaryMid]];
	background: [[ColorPalette::PrimaryPale]];
	border-top: 3px solid [[ColorPalette::PrimaryMid]];
	border-bottom: 3px solid [[ColorPalette::PrimaryMid]];
	border-left: 3px solid [[ColorPalette::PrimaryMid]];
	z-index: 10;
	margin-top: -1px;
	font-weight: bold;
	font-size: 0.4em;
}

#sidebarTabs .tabContents li {
	font-size: 1 em;
	border: none;
	margin-left: 0;
	word-wrap: break-word;
}

.tabContents .timeline {
	font-size: 1em;
	background: [[ColorPalette::PrimaryPale]];
	margin-bottom: 8px;
}

#sidebarTabs .timeline li.listTitle {
	font-size: 1em;
	color: #132E43;
	margin-left: 8px 0;
	padding: 0.3em 0.11em;
	border-bottom: none;
}

#sidebarTabs .tabContents li a {
	font-size: 0.7em;
	display: block;
	text-align: left;
	margin: 0 0 1px 0;
	padding: 0.3em 1em;
	background: [[ColorPalette::PrimaryPale]];
}

#sidebarTabs .tabsetWrapper .tabset a:hover,
#sidebarTabs .tabContents li a:hover {
	color: [[ColorPalette::PrimaryPale]];
	background: [[ColorPalette::PrimaryMid]];
}

/* Activity Stream */
#sidebarTabs .tabContents .activityStream .feedItem a {
	display: inline-block;
	padding: 0;
	background: none;
}

/* ---- Tagging box --- */
.tagInfo {
	border: 1px solid #cccccc;
	padding: 10px 15px;
	-moz-box-shadow: 0 2px 2px rgba(0, 0, 0, 0.2);
	box-shadow: 0 2px 2px rgba(0,0,0,0.2);
	color: [[ColorPalette::TertiaryMid]];
	background: -moz-linear-gradient(100% 100% 90deg, #f4f4f4, #e5e5e5);
	background: -webkit-gradient(linear, left top, right top, from(#e5e5e5), to(#f4f4f4));
	margin-top: 1em;
	font-size: 13px;
	margin: 0 0 0 56px;
}

.tagInfo ul {
	list-style: none;
	padding-left: 2.2em;
}

.tagInfo ul li {
	display: inline;
}

.tagInfo ul li.listTitle,
.tagInfo .tagging ul li.listTitle {
	color: [[ColorPalette::PrimaryMid]];
	font-size: 13px;
}

.tagInfo ul li a {
	border: none;
}

.tagInfo .tagging ul li {
	float: none;
	display: inline-block;
}

.tagInfo .tagging {
	padding: 0;
}

.viewRevision .toolbar {
	right: 48px;
	top: 8px;
}

.viewRevision .modifierIcon img,
.viewRevision .modifierIcon svg {
	margin-right: 8px;
}

.viewRevision .toolbar svg {
	width: 32px;
	height: 32px;
}

/* --- IE hacks from lattice --- */

/* ie hacks */
* html #menuBar {
	margin-bottom: 8px;
}
.toolbar .svgIconText {
	*display: inline;
}

div.tiddler .toolbar a {
	float: left\9;
	display: inline\9;
}

* html .toolbar {
	right: 8px;
}
* html .followButton a {
	margin-top: 0px;
	margin-right: 8px;
}
* html #tiddlerDisplay {
	margin-top: 0px;
}
/* for printing purposes */
@media print {
	#mainMenu,
	#sidebar,
	#messageArea,
	.toolbar,
	.followPlaceHolder,
	#backstageButton,
	#backstageArea,
	#sidebarTabs,
	#sidebarSearch .txtOptionInput,
	#sidebarOptions {
		display: none !important;
	}
	#displayArea {
		margin: 1em 1em 0em;
	}
	noscript {
		display:none; /* Fixes a feature in Firefox 1.5.0.2 where print preview displays the noscript content */
	}
	#tiddlerDisplay {
		margin: 16px 16px;
	}
}

@media all and (max-width: 960px){
	#tiddlerDisplay,
	#searchResults {
		margin: 16px 300px 0 16px;
	}

	#mainMenu {
		margin-left: 16px;
	}

	.headerForeground {
		margin-left: 16px;
	}

	#sidebarSearch {
		right: 16px;
	}

	#sidebarOptions {
		margin-right: 16px;
	}

	#sidebarTabs .tabsetWrapper .tabset {
		font-size: 0.5em;
		width: 57px;
	}

	#sidebarTabs .tabsetWrapper .tabContents {
		width: 160px;
		_width: 156px;
		font-size: 0.5em;
	}

	#sidebarTabs .tabContents li a {
		font-size: 0.5em;
	}
}

/*}}}*/
[[StyleSheetTiddler]]
7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the design and
development stage(s) being reviewed, as well as other specialist personnel (see 5.5.1 and 6.2.1).
Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).
//(c) Activation of tube//
X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure.

When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.
{{{
config.macros.QuickTimeFragment = {
  handler: function (place, macroName, params, wikifier, paramString, tiddler)
  {
     var movie;

     if (params[0] != null)
     {
           movie = params[0];
     }

     resultString = '<html>';
     resultString += '<table border="0" cellpadding="0" align="left">';
     resultString += '<tr><td>';

     resultString += '<object classid="clsid:02BF25D5-8C17-4B23-BC80-D3488ABDDC6B" width="425" height="344" codebase="http://www.apple.com/qtactivex/qtplugin.cab">';
     resultString += '<param name="src" value="';
     resultString += movie;
     resultString += '">';

     resultString += '</param><param name="autoplay" value="false">';
     resultString += '</param><param name="controller" value="true">';
     resultString += '</param><param name="loop" value="false">';

     resultString += '</param><embed src="';
     resultString += movie;
     resultString += '"allowfullscreen="true" autoplay="false" width="425" height="344">';
     resultString += ' </embed></object> ';
     resultString += '</tr></td>';
     resultString += '</table>';
     resultString += '</html>';

     wikify(resultString,place);
   }
 }
}}}
''5.3 Quality policy''

Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability.
''5.6.2 Review input''

The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system,
g) recommendations for improvement, and
h) new or revised regulatory requirements.
7.4.1 Purchasing process

The organization shall establish documented procedures to ensure that purchased product conforms to
specified purchase requirements.

The type and extent of control applied to the supplier and the purchased product shall be dependent upon the
effect of the purchased product on subsequent product realization or the final product.

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established.

Records of the results of evaluations and any necessary actions arising from the evaluation shall be
maintained (see 4.2.4).
''7.4.2 Purchasing information''

Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication
to the supplier.

To the extent required for traceability given in 7.5.3.2, the organization shall maintain relevant purchasing
information, i.e. documents (see 4.2.3) and records (see 4.2.4).

''Complaint handling and vigilance''
* Assistance with Post Market Surveillance activities
* Identification / traceability of products to end users
* Storage conditions at the warehouse and during transport (if applicable)
* Handling conditions
* Packaging and/or labelling activities (if applicable)
* Training of the employee(s) of the distributor(s) on relevant issues of procedures and documentation on above topics
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part.

The followog terms and concepts are relevant to 21-840 - Document Controls
<<forEachTiddler
    where
        'tiddler.tags.contains("CFR 21-820.40")'
    sortBy 
         'tiddler.title.toUpperCase()'
   write
         '"* [["+tiddler.title+"]]" + "\n"'

>>
ISO 13485 is derived from [[ISO 9001]]


<<tiddler [[ISO13485 - Clause 0: Introduction]]>>

<<tiddler [[ISO13485 - Clause 1 Scope]]>>

<<tiddler [[ISO13485 - Clause 2 Normative references]]>>

<<tiddler [[ISO13485 - Clause 3 Terms & definitions]]>>

<<tiddler [[ISO13485 - 4.1 General Requirements]]>>

<<tiddler [[ISO13485 - 4.2.1 General]]>>

<<tiddler [[ISO13485 - 4.2.2 Quality manual]]>>

<<tiddler [[ISO13485 - 4.2.3 Control of documents]]>>

<<tiddler [[ISO13485 - 4.2.4 Control of records Tiddler]]>>

<<tiddler [[ISO13485 - 5.1 Management commitment]]>>

<<tiddler [[ISO13485 - 5.2 Customer focus>>

<<tiddler [[ISO13485 - 5.3 Quality policy>>

<<tiddler [[ISO13485 - 5.4.1 Quality objectives>>

<<tiddler [[ISO13485 - 5.4.2 Quality management system planning>>

<<tiddler [[ISO13485 - Responsibility and authority>>

<<tiddler [[ISO13485 - 5.5.3 Internal communication>>

<<tiddler [[ISO13485 - 5.6.1 General>>

<<tiddler [[ISO13485 - 5.6.2 Review input>>

<<tiddler [[ISO13485 - 6.1 Provision of resources>>

<<tiddler [[ISO13485 - 6.2.2 Competence, awareness and training>>

<<tiddler [[ISO13485 - 6.4 Work environment>>

<<tiddler [[ISO13485 - 7.1 Planning of product realization>>

<<tiddler [[ISO13485 - 7.2.1 Determination of requirements related to the product>>

<<tiddler [[ISO13485 - 7.2.3 Customer communication>>

<<tiddler [[ISO13485 - 7.3.1 Design and development planning>>

<<tiddler [[ISO13485 - 7.3.2 Design and development input>>

<<tiddler [[ISO13485 - 7.3.3 Design and development outputs>>

<<tiddler [[ISO13485 - 7.3.4 Design and development review>>

<<tiddler [[ISO13485 - 7.3.6 Design and development validation>>

<<tiddler [[ISO13485 - 7.4.1 Purchasing process>>

<<tiddler [[ISO13485 - 7.4.2 Purchasing information>>

<<tiddler [[ISO13485 - 7.4.3 Verification of purchased product>>

<<tiddler [[ISO13485 - Control of production and service provision - 7.5.1.1 General requirements>>
[[About]] [[Books]] [[Terms]] [[Audio]] [[Video]] [[Bookmarks]]
''7.3.3 Design and development outputs''

The outputs of design and development shall be provided in a form that enables verification against the
design and development input and shall be approved prior to release.

Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.
Records of the design and development outputs shall be maintained (see 4.2.4).
NOTE Records of design and development outputs can include specifications, manufacturing procedures, engineering drawings, and engineering or research logbooks.
Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase.

Software verification looks for
* [[Consistency]]
* [[Completeness]] and
* [[Correctness]]
of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated. [[Software Testing]] is one of many verification activities intended to confirm that software development output meets its input requirements. Other verification activities include: various
* [[Static analysis]]
* [[Dynamic analysis]]
* Code and document inspections
* Code walkthroughs
and other techniques
Each manufacturer shall establish and maintain procedures for verifying the device design. Design [[verification|Verification]] shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the [[Design History File]] (DHF).
!Attention points
Design verification and validation are two different activities:
* Design verifications intent is to ensure that the [[Design Outputs|CFR 21-820.30d - Design Output]] meet the [[Design Inputs|CFR 21-820.30c - Design Input]]. Design verification can be described as the activities with determining if the device was made 'right'.
* Design validation refers to activities that determine whether the device was made correctly and whether the device meets its intended uses.

See also the picture below to see the difference:
<<image /static/files/FDA/82030a.jpg width:400>>

!Design verification and validation activities
<<tiddler [[Design verification and validation activities]]>>

[[Software Verification]] is a special topic in the context of design verification.
/***
|Name|Plugin: jsMath|
|Created by|BobMcElrath|
|Email|my first name at my last name dot org|
|Location|http://bob.mcelrath.org/tiddlyjsmath.html|
|Version|1.5.1|
|Requires|[[TiddlyWiki|http://www.tiddlywiki.com]] &ge; 2.0.3, [[jsMath|http://www.math.union.edu/~dpvc/jsMath/]] &ge; 3.0|
!Description
LaTeX is the world standard for specifying, typesetting, and communicating mathematics among scientists, engineers, and mathematicians.  For more information about LaTeX itself, visit the [[LaTeX Project|http://www.latex-project.org/]].  This plugin typesets math using [[jsMath|http://www.math.union.edu/~dpvc/jsMath/]], which is an implementation of the TeX math rules and typesetting in javascript, for your browser.  Notice the small button in the lower right corner which opens its control panel.
!Installation
In addition to this plugin, you must also [[install jsMath|http://www.math.union.edu/~dpvc/jsMath/download/jsMath.html]] on the same server as your TiddlyWiki html file.  If you're using TiddlyWiki without a web server, then the jsMath directory must be placed in the same location as the TiddlyWiki html file.

I also recommend modifying your StyleSheet use serif fonts that are slightly larger than normal, so that the math matches surrounding text, and \\small fonts are not unreadable (as in exponents and subscripts).a
{{{
.viewer {
  line-height: 125%;
  font-family: serif;
  font-size: 12pt;
}
}}}

If you had used a previous version of [[Plugin: jsMath]], it is no longer necessary to edit the main tiddlywiki.html file to add the jsMath <script> tag.  [[Plugin: jsMath]] now uses ajax to load jsMath.
!History
* 11-Nov-05, version 1.0, Initial release
* 22-Jan-06, version 1.1, updated for ~TW2.0, tested with jsMath 3.1, editing tiddlywiki.html by hand is no longer necessary.
* 24-Jan-06, version 1.2, fixes for Safari, Konqueror
* 27-Jan-06, version 1.3, improved error handling, detect if ajax was already defined (used by ZiddlyWiki)
* 12-Jul-06, version 1.4, fixed problem with not finding image fonts
* 26-Feb-07, version 1.5, fixed problem with Mozilla "unterminated character class".
* 27-Feb-07, version 1.5.1, Runs compatibly with TW 2.1.0+, by Bram Chen
!Examples
|!Source|!Output|h
|{{{The variable $x$ is real.}}}|The variable $x$ is real.|
|{{{The variable \(y\) is complex.}}}|The variable \(y\) is complex.|
|{{{This \[\int_a^b x = \frac{1}{2}(b^2-a^2)\] is an easy integral.}}}|This \[\int_a^b x = \frac{1}{2}(b^2-a^2)\] is an easy integral.|
|{{{This $$\int_a^b \sin x = -(\cos b - \cos a)$$ is another easy integral.}}}|This $$\int_a^b \sin x = -(\cos b - \cos a)$$ is another easy integral.|
|{{{Block formatted equations may also use the 'equation' environment \begin{equation}  \int \tan x = -\ln \cos x \end{equation} }}}|Block formatted equations may also use the 'equation' environment \begin{equation}  \int \tan x = -\ln \cos x \end{equation}|
|{{{Equation arrays are also supported \begin{eqnarray} a &=& b \\ c &=& d \end{eqnarray} }}}|Equation arrays are also supported \begin{eqnarray} a &=& b \\ c &=& d \end{eqnarray} |
|{{{I spent \$7.38 on lunch.}}}|I spent \$7.38 on lunch.|
|{{{I had to insert a backslash (\\) into my document}}}|I had to insert a backslash (\\) into my document|
!Code
***/
//{{{

// AJAX code adapted from http://timmorgan.org/mini
// This is already loaded by ziddlywiki...
if(typeof(window["ajax"]) == "undefined") {
  ajax = {
      x: function(){try{return new ActiveXObject('Msxml2.XMLHTTP')}catch(e){try{return new ActiveXObject('Microsoft.XMLHTTP')}catch(e){return new XMLHttpRequest()}}},
      gets: function(url){var x=ajax.x();x.open('GET',url,false);x.send(null);return x.responseText}
  }
}

// Load jsMath
jsMath = {
  Setup: {inited: 1},          // don't run jsMath.Setup.Body() yet
  Autoload: {root: '/static/jsMath/', showFontWarnings: 0}  // URL to jsMath directory, change if necessary
};
var jsMathstr;
try {
  jsMathstr = ajax.gets("/static/jsMath/jsMath.js");
} catch(e) {
  alert("jsMath was not found: you must place the 'jsMath' directory in the same place as this file.  "
       +"The error was:\n"+e.name+": "+e.message);
  throw(e);  // abort eval
}
try {
  window.eval(jsMathstr);
} catch(e) {
  alert("jsMath failed to load.  The error was:\n"+e.name + ": " + e.message + " on line " + e.lineNumber);
}
jsMath.Setup.inited=0;  //  allow jsMath.Setup.Body() to run again

// Define wikifers for latex
config.formatterHelpers.mathFormatHelper = function(w) {
    var e = document.createElement(this.element);
    e.className = this.className;
    var endRegExp = new RegExp(this.terminator, "mg");
    endRegExp.lastIndex = w.matchStart+w.matchLength;
    var matched = endRegExp.exec(w.source);
    if(matched) {
        var txt = w.source.substr(w.matchStart+w.matchLength, 
            matched.index-w.matchStart-w.matchLength);
        if(this.keepdelim) {
          txt = w.source.substr(w.matchStart, matched.index+matched[0].length-w.matchStart);
        }
        e.appendChild(document.createTextNode(txt));
        w.output.appendChild(e);
        w.nextMatch = endRegExp.lastIndex;
    }
}

config.formatters.push({
  name: "displayMath1",
  match: "\\\$\\\$",
  terminator: "\\\$\\\$\\n?", // 2.0 compatability
  termRegExp: "\\\$\\\$\\n?",
  element: "div",
  className: "math",
  handler: config.formatterHelpers.mathFormatHelper
});

config.formatters.push({
  name: "inlineMath1",
  match: "\\\$", 
  terminator: "\\\$", // 2.0 compatability
  termRegExp: "\\\$",
  element: "span",
  className: "math",
  handler: config.formatterHelpers.mathFormatHelper
});

var backslashformatters = new Array(0);

backslashformatters.push({
  name: "inlineMath2",
  match: "\\\\\\\(",
  terminator: "\\\\\\\)", // 2.0 compatability
  termRegExp: "\\\\\\\)",
  element: "span",
  className: "math",
  handler: config.formatterHelpers.mathFormatHelper
});

backslashformatters.push({
  name: "displayMath2",
  match: "\\\\\\\[",
  terminator: "\\\\\\\]\\n?", // 2.0 compatability
  termRegExp: "\\\\\\\]\\n?",
  element: "div",
  className: "math",
  handler: config.formatterHelpers.mathFormatHelper
});

backslashformatters.push({
  name: "displayMath3",
  match: "\\\\begin\\{equation\\}",
  terminator: "\\\\end\\{equation\\}\\n?", // 2.0 compatability
  termRegExp: "\\\\end\\{equation\\}\\n?",
  element: "div",
  className: "math",
  handler: config.formatterHelpers.mathFormatHelper
});

// These can be nested.  e.g. \begin{equation} \begin{array}{ccc} \begin{array}{ccc} ...
backslashformatters.push({
  name: "displayMath4",
  match: "\\\\begin\\{eqnarray\\}",
  terminator: "\\\\end\\{eqnarray\\}\\n?", // 2.0 compatability
  termRegExp: "\\\\end\\{eqnarray\\}\\n?",
  element: "div",
  className: "math",
  keepdelim: true,
  handler: config.formatterHelpers.mathFormatHelper
});

// The escape must come between backslash formatters and regular ones.
// So any latex-like \commands must be added to the beginning of
// backslashformatters here.
backslashformatters.push({
    name: "escape",
    match: "\\\\.",
    handler: function(w) {
        w.output.appendChild(document.createTextNode(w.source.substr(w.matchStart+1,1)));
        w.nextMatch = w.matchStart+2;
    }
});

config.formatters=backslashformatters.concat(config.formatters);

window.wikify = function(source,output,highlightRegExp,tiddler)
{
    if(source && source != "") {
        if(version.major == 2 && version.minor > 0) {
            var wikifier = new Wikifier(source,getParser(tiddler),highlightRegExp,tiddler);
            wikifier.subWikifyUnterm(output);
        } else {
            var wikifier = new Wikifier(source,formatter,highlightRegExp,tiddler);
            wikifier.subWikify(output,null);
        }
        jsMath.Synchronize("jsMath.Font.HideMessage()") 
        jsMath.ProcessBeforeShowing();
    }
}
//}}}
Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
!Attention points
There are two principal administrative elements involved in controlling design changes:
* [[Document Control]]—enumeration of design documents, and tracking their status and revision history.  Throughout this section, the term “document” is used in an inclusive sense to mean all design documents, drawings, and other items of design input or output which characterize the design or some aspect of it.
* [[Change Control]] —enumeration of deficiencies and corrective actions arising from verification and review of the design, and tracking their resolution prior to design transfer.
* The design control system has to be concerned with the creation and revision of documents, as well as the management of finished documents.
* It is important that the design change procedures always include re-verifying and revalidating the design.
** Fortunately, most design changes occur early in the design process, prior to extensive design validation.
*** Thus, for most design changes, a simple inspection is all that is required.
** The later in the development cycle that the change occurs, the more important the validation review becomes.
Medical Device Directive

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 [1] concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards'[2] have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.


http://en.wikipedia.org/wiki/Medical_Devices_Directive
{{{
//{{{
config.macros.PlotFunction = {
  handler: function (place, macroName, params, wikifier, paramString, tiddler)
  {
     var resultString;
     var wolframAlphaQuery;

     var xml;
     var width = '500';
     var height = '270';

     if (params[1] != null)
     {
           width = params[1];
     }

     if (params[2] != null)
     {
           height = params[2];
     }

     wolframAlphaQuery = '/query_wolfram/v1/query?input=';
     wolframAlphaQuery += params[0];
     wolframAlphaQuery += '&format=image&appid=beta824g5';
     var xmlDoc=document.implementation.createDocument("","",null);

     resultString = "<html>";
     resultString += '<iframe ';
     resultString += 'src="';
     resultString += QueryWolframAlpha(wolframAlphaQuery);
     resultString += '"';
     resultString += ' width=' + width;
     resultString += ' height=' + height;
     resultString +='">';
     resultString += '</iframe>';
     resultString += '</html>';

     wikify(resultString,place);
   }
 }

function QueryWolframAlpha(s)
{
     var xmlhttp=false;
     var resultString = "";
     var partialResultString  = "";
     var xmlDoc;

     try {
          xmlhttp = new XMLHttpRequest();
     } catch (e) {
          xmlhttp=false;
     }

     xmlhttp.open("GET",s,false);
     xmlhttp.send(null);
     if (xmlhttp.readyState==4) {
          xmlDoc = xmlhttp.responseXML;
          var xPathRes;
              xPathRes= xmlDoc.evaluate('/queryresult[@success="true"]/pod[@title="Plots"]/subpod[@title=""]/img/@src', xmlDoc, null, XPathResult.ANY_TYPE,null);
               if (xPathRes.resultType == 4)
               {
                    xPathRes = xPathRes.iterateNext();
                    partialResultString = xPathRes.value;
               }
     }
     return (partialResultString);
}

//}}}
}}}
Medical Device Regulations - [[MDD]] for Canada.
@@Please do not modify this tiddler; it was created automatically upon space creation.@@
Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

!Attention points
* Each document should have an owner for approval
* Document should be available to stakeholders. Distribution of documents should be controlled.
* Obsolete documents should be removed to prvenet unintended use!
@@Please do not modify this tiddler; it was created automatically upon space creation.@@
''7.3.2 Design and development inputs''

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
a) functional, performance and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management (see 7.1).
These inputs shall be reviewed for adequacy and approved.

Requirements shall be complete, unambiguous and not in conflict with each other.
/***
|''Name:''|ForEachTiddlerPlugin|
|''Version:''|1.0.8 (2007-04-12)|
|''Source:''|http://tiddlywiki.abego-software.de/#ForEachTiddlerPlugin|
|''Author:''|UdoBorkowski (ub [at] abego-software [dot] de)|
|''Licence:''|[[BSD open source license (abego Software)|http://www.abego-software.de/legal/apl-v10.html]]|
|''Copyright:''|&copy; 2005-2007 [[abego Software|http://www.abego-software.de]]|
|''TiddlyWiki:''|1.2.38+, 2.0|
|''Browser:''|Firefox 1.0.4+; Firefox 1.5; InternetExplorer 6.0|
!Description

Create customizable lists, tables etc. for your selections of tiddlers. Specify the tiddlers to include and their order through a powerful language.

''Syntax:'' 
|>|{{{<<}}}''forEachTiddler'' [''in'' //tiddlyWikiPath//] [''where'' //whereCondition//] [''sortBy'' //sortExpression// [''ascending'' //or// ''descending'']] [''script'' //scriptText//] [//action// [//actionParameters//]]{{{>>}}}|
|//tiddlyWikiPath//|The filepath to the TiddlyWiki the macro should work on. When missing the current TiddlyWiki is used.|
|//whereCondition//|(quoted) JavaScript boolean expression. May refer to the build-in variables {{{tiddler}}} and  {{{context}}}.|
|//sortExpression//|(quoted) JavaScript expression returning "comparable" objects (using '{{{<}}}','{{{>}}}','{{{==}}}'. May refer to the build-in variables {{{tiddler}}} and  {{{context}}}.|
|//scriptText//|(quoted) JavaScript text. Typically defines JavaScript functions that are called by the various JavaScript expressions (whereClause, sortClause, action arguments,...)|
|//action//|The action that should be performed on every selected tiddler, in the given order. By default the actions [[addToList|AddToListAction]] and [[write|WriteAction]] are supported. When no action is specified [[addToList|AddToListAction]]  is used.|
|//actionParameters//|(action specific) parameters the action may refer while processing the tiddlers (see action descriptions for details). <<tiddler [[JavaScript in actionParameters]]>>|
|>|~~Syntax formatting: Keywords in ''bold'', optional parts in [...]. 'or' means that exactly one of the two alternatives must exist.~~|

See details see [[ForEachTiddlerMacro]] and [[ForEachTiddlerExamples]].

!Revision history
* v1.0.8 (2007-04-12)
** Adapted to latest TiddlyWiki 2.2 Beta importTiddlyWiki API (introduced with changeset 2004). TiddlyWiki 2.2 Beta builds prior to changeset 2004 are no longer supported (but TiddlyWiki 2.1 and earlier, of cause)
* v1.0.7 (2007-03-28)
** Also support "pre" formatted TiddlyWikis (introduced with TW 2.2) (when using "in" clause to work on external tiddlers)
* v1.0.6 (2006-09-16)
** Context provides "viewerTiddler", i.e. the tiddler used to view the macro. Most times this is equal to the "inTiddler", but when using the "tiddler" macro both may be different.
** Support "begin", "end" and "none" expressions in "write" action
* v1.0.5 (2006-02-05)
** Pass tiddler containing the macro with wikify, context object also holds reference to tiddler containing the macro ("inTiddler"). Thanks to SimonBaird.
** Support Firefox 1.5.0.1
** Internal
*** Make "JSLint" conform
*** "Only install once"
* v1.0.4 (2006-01-06)
** Support TiddlyWiki 2.0
* v1.0.3 (2005-12-22)
** Features: 
*** Write output to a file supports multi-byte environments (Thanks to Bram Chen) 
*** Provide API to access the forEachTiddler functionality directly through JavaScript (see getTiddlers and performMacro)
** Enhancements:
*** Improved error messages on InternetExplorer.
* v1.0.2 (2005-12-10)
** Features: 
*** context object also holds reference to store (TiddlyWiki)
** Fixed Bugs: 
*** ForEachTiddler 1.0.1 has broken support on win32 Opera 8.51 (Thanks to BrunoSabin for reporting)
* v1.0.1 (2005-12-08)
** Features: 
*** Access tiddlers stored in separated TiddlyWikis through the "in" option. I.e. you are no longer limited to only work on the "current TiddlyWiki".
*** Write output to an external file using the "toFile" option of the "write" action. With this option you may write your customized tiddler exports.
*** Use the "script" section to define "helper" JavaScript functions etc. to be used in the various JavaScript expressions (whereClause, sortClause, action arguments,...).
*** Access and store context information for the current forEachTiddler invocation (through the build-in "context" object) .
*** Improved script evaluation (for where/sort clause and write scripts).
* v1.0.0 (2005-11-20)
** initial version

!Code
***/
//{{{

	
//============================================================================
//============================================================================
//		   ForEachTiddlerPlugin
//============================================================================
//============================================================================

// Only install once
if (!version.extensions.ForEachTiddlerPlugin) {

if (!window.abego) window.abego = {};

version.extensions.ForEachTiddlerPlugin = {
	major: 1, minor: 0, revision: 8, 
	date: new Date(2007,3,12), 
	source: "http://tiddlywiki.abego-software.de/#ForEachTiddlerPlugin",
	licence: "[[BSD open source license (abego Software)|http://www.abego-software.de/legal/apl-v10.html]]",
	copyright: "Copyright (c) abego Software GmbH, 2005-2007 (www.abego-software.de)"
};

// For backward compatibility with TW 1.2.x
//
if (!TiddlyWiki.prototype.forEachTiddler) {
	TiddlyWiki.prototype.forEachTiddler = function(callback) {
		for(var t in this.tiddlers) {
			callback.call(this,t,this.tiddlers[t]);
		}
	};
}

//============================================================================
// forEachTiddler Macro
//============================================================================

version.extensions.forEachTiddler = {
	major: 1, minor: 0, revision: 8, date: new Date(2007,3,12), provider: "http://tiddlywiki.abego-software.de"};

// ---------------------------------------------------------------------------
// Configurations and constants 
// ---------------------------------------------------------------------------

config.macros.forEachTiddler = {
	 // Standard Properties
	 label: "forEachTiddler",
	 prompt: "Perform actions on a (sorted) selection of tiddlers",

	 // actions
	 actions: {
		 addToList: {},
		 write: {}
	 }
};

// ---------------------------------------------------------------------------
//  The forEachTiddler Macro Handler 
// ---------------------------------------------------------------------------

config.macros.forEachTiddler.getContainingTiddler = function(e) {
	while(e && !hasClass(e,"tiddler"))
		e = e.parentNode;
	var title = e ? e.getAttribute("tiddler") : null; 
	return title ? store.getTiddler(title) : null;
};

config.macros.forEachTiddler.handler = function(place,macroName,params,wikifier,paramString,tiddler) {
	// config.macros.forEachTiddler.traceMacroCall(place,macroName,params,wikifier,paramString,tiddler);

	if (!tiddler) tiddler = config.macros.forEachTiddler.getContainingTiddler(place);
	// --- Parsing ------------------------------------------

	var i = 0; // index running over the params
	// Parse the "in" clause
	var tiddlyWikiPath = undefined;
	if ((i < params.length) && params[i] == "in") {
		i++;
		if (i >= params.length) {
			this.handleError(place, "TiddlyWiki path expected behind 'in'.");
			return;
		}
		tiddlyWikiPath = this.paramEncode((i < params.length) ? params[i] : "");
		i++;
	}

	// Parse the where clause
	var whereClause ="true";
	if ((i < params.length) && params[i] == "where") {
		i++;
		whereClause = this.paramEncode((i < params.length) ? params[i] : "");
		i++;
	}

	// Parse the sort stuff
	var sortClause = null;
	var sortAscending = true; 
	if ((i < params.length) && params[i] == "sortBy") {
		i++;
		if (i >= params.length) {
			this.handleError(place, "sortClause missing behind 'sortBy'.");
			return;
		}
		sortClause = this.paramEncode(params[i]);
		i++;

		if ((i < params.length) && (params[i] == "ascending" || params[i] == "descending")) {
			 sortAscending = params[i] == "ascending";
			 i++;
		}
	}

	// Parse the script
	var scriptText = null;
	if ((i < params.length) && params[i] == "script") {
		i++;
		scriptText = this.paramEncode((i < params.length) ? params[i] : "");
		i++;
	}

	// Parse the action. 
	// When we are already at the end use the default action
	var actionName = "addToList";
	if (i < params.length) {
	   if (!config.macros.forEachTiddler.actions[params[i]]) {
			this.handleError(place, "Unknown action '"+params[i]+"'.");
			return;
		} else {
			actionName = params[i]; 
			i++;
		}
	} 
	
	// Get the action parameter
	// (the parsing is done inside the individual action implementation.)
	var actionParameter = params.slice(i);


	// --- Processing ------------------------------------------
	try {
		this.performMacro({
				place: place, 
				inTiddler: tiddler,
				whereClause: whereClause, 
				sortClause: sortClause, 
				sortAscending: sortAscending, 
				actionName: actionName, 
				actionParameter: actionParameter, 
				scriptText: scriptText, 
				tiddlyWikiPath: tiddlyWikiPath});

	} catch (e) {
		this.handleError(place, e);
	}
};

// Returns an object with properties "tiddlers" and "context".
// tiddlers holds the (sorted) tiddlers selected by the parameter,
// context the context of the execution of the macro.
//
// The action is not yet performed.
//
// @parameter see performMacro
//
config.macros.forEachTiddler.getTiddlersAndContext = function(parameter) {

	var context = config.macros.forEachTiddler.createContext(parameter.place, parameter.whereClause, parameter.sortClause, parameter.sortAscending, parameter.actionName, parameter.actionParameter, parameter.scriptText, parameter.tiddlyWikiPath, parameter.inTiddler);

	var tiddlyWiki = parameter.tiddlyWikiPath ? this.loadTiddlyWiki(parameter.tiddlyWikiPath) : store;
	context["tiddlyWiki"] = tiddlyWiki;
	
	// Get the tiddlers, as defined by the whereClause
	var tiddlers = this.findTiddlers(parameter.whereClause, context, tiddlyWiki);
	context["tiddlers"] = tiddlers;

	// Sort the tiddlers, when sorting is required.
	if (parameter.sortClause) {
		this.sortTiddlers(tiddlers, parameter.sortClause, parameter.sortAscending, context);
	}

	return {tiddlers: tiddlers, context: context};
};

// Returns the (sorted) tiddlers selected by the parameter.
//
// The action is not yet performed.
//
// @parameter see performMacro
//
config.macros.forEachTiddler.getTiddlers = function(parameter) {
	return this.getTiddlersAndContext(parameter).tiddlers;
};

// Performs the macros with the given parameter.
//
// @param parameter holds the parameter of the macro as separate properties.
//				  The following properties are supported:
//
//						place
//						whereClause
//						sortClause
//						sortAscending
//						actionName
//						actionParameter
//						scriptText
//						tiddlyWikiPath
//
//					All properties are optional. 
//					For most actions the place property must be defined.
//
config.macros.forEachTiddler.performMacro = function(parameter) {
	var tiddlersAndContext = this.getTiddlersAndContext(parameter);

	// Perform the action
	var actionName = parameter.actionName ? parameter.actionName : "addToList";
	var action = config.macros.forEachTiddler.actions[actionName];
	if (!action) {
		this.handleError(parameter.place, "Unknown action '"+actionName+"'.");
		return;
	}

	var actionHandler = action.handler;
	actionHandler(parameter.place, tiddlersAndContext.tiddlers, parameter.actionParameter, tiddlersAndContext.context);
};

// ---------------------------------------------------------------------------
//  The actions 
// ---------------------------------------------------------------------------

// Internal.
//
// --- The addToList Action -----------------------------------------------
//
config.macros.forEachTiddler.actions.addToList.handler = function(place, tiddlers, parameter, context) {
	// Parse the parameter
	var p = 0;

	// Check for extra parameters
	if (parameter.length > p) {
		config.macros.forEachTiddler.createExtraParameterErrorElement(place, "addToList", parameter, p);
		return;
	}

	// Perform the action.
	var list = document.createElement("ul");
	place.appendChild(list);
	for (var i = 0; i < tiddlers.length; i++) {
		var tiddler = tiddlers[i];
		var listItem = document.createElement("li");
		list.appendChild(listItem);
		createTiddlyLink(listItem, tiddler.title, true);
	}
};

abego.parseNamedParameter = function(name, parameter, i) {
	var beginExpression = null;
	if ((i < parameter.length) && parameter[i] == name) {
		i++;
		if (i >= parameter.length) {
			throw "Missing text behind '%0'".format([name]);
		}
		
		return config.macros.forEachTiddler.paramEncode(parameter[i]);
	}
	return null;
}

// Internal.
//
// --- The write Action ---------------------------------------------------
//
config.macros.forEachTiddler.actions.write.handler = function(place, tiddlers, parameter, context) {
	// Parse the parameter
	var p = 0;
	if (p >= parameter.length) {
		this.handleError(place, "Missing expression behind 'write'.");
		return;
	}

	var textExpression = config.macros.forEachTiddler.paramEncode(parameter[p]);
	p++;

	// Parse the "begin" option
	var beginExpression = abego.parseNamedParameter("begin", parameter, p);
	if (beginExpression !== null) 
		p += 2;
	var endExpression = abego.parseNamedParameter("end", parameter, p);
	if (endExpression !== null) 
		p += 2;
	var noneExpression = abego.parseNamedParameter("none", parameter, p);
	if (noneExpression !== null) 
		p += 2;

	// Parse the "toFile" option
	var filename = null;
	var lineSeparator = undefined;
	if ((p < parameter.length) && parameter[p] == "toFile") {
		p++;
		if (p >= parameter.length) {
			this.handleError(place, "Filename expected behind 'toFile' of 'write' action.");
			return;
		}
		
		filename = config.macros.forEachTiddler.getLocalPath(config.macros.forEachTiddler.paramEncode(parameter[p]));
		p++;
		if ((p < parameter.length) && parameter[p] == "withLineSeparator") {
			p++;
			if (p >= parameter.length) {
				this.handleError(place, "Line separator text expected behind 'withLineSeparator' of 'write' action.");
				return;
			}
			lineSeparator = config.macros.forEachTiddler.paramEncode(parameter[p]);
			p++;
		}
	}
	
	// Check for extra parameters
	if (parameter.length > p) {
		config.macros.forEachTiddler.createExtraParameterErrorElement(place, "write", parameter, p);
		return;
	}

	// Perform the action.
	var func = config.macros.forEachTiddler.getEvalTiddlerFunction(textExpression, context);
	var count = tiddlers.length;
	var text = "";
	if (count > 0 && beginExpression)
		text += config.macros.forEachTiddler.getEvalTiddlerFunction(beginExpression, context)(undefined, context, count, undefined);
	
	for (var i = 0; i < count; i++) {
		var tiddler = tiddlers[i];
		text += func(tiddler, context, count, i);
	}
	
	if (count > 0 && endExpression)
		text += config.macros.forEachTiddler.getEvalTiddlerFunction(endExpression, context)(undefined, context, count, undefined);

	if (count == 0 && noneExpression) 
		text += config.macros.forEachTiddler.getEvalTiddlerFunction(noneExpression, context)(undefined, context, count, undefined);
		

	if (filename) {
		if (lineSeparator !== undefined) {
			lineSeparator = lineSeparator.replace(/\\n/mg, "\n").replace(/\\r/mg, "\r");
			text = text.replace(/\n/mg,lineSeparator);
		}
		saveFile(filename, convertUnicodeToUTF8(text));
	} else {
		var wrapper = createTiddlyElement(place, "span");
		wikify(text, wrapper, null/* highlightRegExp */, context.inTiddler);
	}
};


// ---------------------------------------------------------------------------
//  Helpers
// ---------------------------------------------------------------------------

// Internal.
//
config.macros.forEachTiddler.createContext = function(placeParam, whereClauseParam, sortClauseParam, sortAscendingParam, actionNameParam, actionParameterParam, scriptText, tiddlyWikiPathParam, inTiddlerParam) {
	return {
		place : placeParam, 
		whereClause : whereClauseParam, 
		sortClause : sortClauseParam, 
		sortAscending : sortAscendingParam, 
		script : scriptText,
		actionName : actionNameParam, 
		actionParameter : actionParameterParam,
		tiddlyWikiPath : tiddlyWikiPathParam,
		inTiddler : inTiddlerParam, // the tiddler containing the <<forEachTiddler ...>> macro call.
		viewerTiddler : config.macros.forEachTiddler.getContainingTiddler(placeParam) // the tiddler showing the forEachTiddler result
	};
};

// Internal.
//
// Returns a TiddlyWiki with the tiddlers loaded from the TiddlyWiki of 
// the given path.
//
config.macros.forEachTiddler.loadTiddlyWiki = function(path, idPrefix) {
	if (!idPrefix) {
		idPrefix = "store";
	}
	var lenPrefix = idPrefix.length;
	
	// Read the content of the given file
	var content = loadFile(this.getLocalPath(path));
	if(content === null) {
		throw "TiddlyWiki '"+path+"' not found.";
	}
	
	var tiddlyWiki = new TiddlyWiki();

	// Starting with TW 2.2 there is a helper function to import the tiddlers
	if (tiddlyWiki.importTiddlyWiki) {
		if (!tiddlyWiki.importTiddlyWiki(content))
			throw "File '"+path+"' is not a TiddlyWiki.";
		tiddlyWiki.dirty = false;
		return tiddlyWiki;
	}
	
	// The legacy code, for TW < 2.2
	
	// Locate the storeArea div's
	var posOpeningDiv = content.indexOf(startSaveArea);
	var posClosingDiv = content.lastIndexOf(endSaveArea);
	if((posOpeningDiv == -1) || (posClosingDiv == -1)) {
		throw "File '"+path+"' is not a TiddlyWiki.";
	}
	var storageText = content.substr(posOpeningDiv + startSaveArea.length, posClosingDiv);
	
	// Create a "div" element that contains the storage text
	var myStorageDiv = document.createElement("div");
	myStorageDiv.innerHTML = storageText;
	myStorageDiv.normalize();
	
	// Create all tiddlers in a new TiddlyWiki
	// (following code is modified copy of TiddlyWiki.prototype.loadFromDiv)
	var store = myStorageDiv.childNodes;
	for(var t = 0; t < store.length; t++) {
		var e = store[t];
		var title = null;
		if(e.getAttribute)
			title = e.getAttribute("tiddler");
		if(!title && e.id && e.id.substr(0,lenPrefix) == idPrefix)
			title = e.id.substr(lenPrefix);
		if(title && title !== "") {
			var tiddler = tiddlyWiki.createTiddler(title);
			tiddler.loadFromDiv(e,title);
		}
	}
	tiddlyWiki.dirty = false;

	return tiddlyWiki;
};


	
// Internal.
//
// Returns a function that has a function body returning the given javaScriptExpression.
// The function has the parameters:
// 
//	 (tiddler, context, count, index)
//
config.macros.forEachTiddler.getEvalTiddlerFunction = function (javaScriptExpression, context) {
	var script = context["script"];
	var functionText = "var theFunction = function(tiddler, context, count, index) { return "+javaScriptExpression+"}";
	var fullText = (script ? script+";" : "")+functionText+";theFunction;";
	return eval(fullText);
};

// Internal.
//
config.macros.forEachTiddler.findTiddlers = function(whereClause, context, tiddlyWiki) {
	var result = [];
	var func = config.macros.forEachTiddler.getEvalTiddlerFunction(whereClause, context);
	tiddlyWiki.forEachTiddler(function(title,tiddler) {
		if (func(tiddler, context, undefined, undefined)) {
			result.push(tiddler);
		}
	});
	return result;
};

// Internal.
//
config.macros.forEachTiddler.createExtraParameterErrorElement = function(place, actionName, parameter, firstUnusedIndex) {
	var message = "Extra parameter behind '"+actionName+"':";
	for (var i = firstUnusedIndex; i < parameter.length; i++) {
		message += " "+parameter[i];
	}
	this.handleError(place, message);
};

// Internal.
//
config.macros.forEachTiddler.sortAscending = function(tiddlerA, tiddlerB) {
	var result = 
		(tiddlerA.forEachTiddlerSortValue == tiddlerB.forEachTiddlerSortValue) 
			? 0
			: (tiddlerA.forEachTiddlerSortValue < tiddlerB.forEachTiddlerSortValue)
			   ? -1 
			   : +1; 
	return result;
};

// Internal.
//
config.macros.forEachTiddler.sortDescending = function(tiddlerA, tiddlerB) {
	var result = 
		(tiddlerA.forEachTiddlerSortValue == tiddlerB.forEachTiddlerSortValue) 
			? 0
			: (tiddlerA.forEachTiddlerSortValue < tiddlerB.forEachTiddlerSortValue)
			   ? +1 
			   : -1; 
	return result;
};

// Internal.
//
config.macros.forEachTiddler.sortTiddlers = function(tiddlers, sortClause, ascending, context) {
	// To avoid evaluating the sortClause whenever two items are compared 
	// we pre-calculate the sortValue for every item in the array and store it in a 
	// temporary property ("forEachTiddlerSortValue") of the tiddlers.
	var func = config.macros.forEachTiddler.getEvalTiddlerFunction(sortClause, context);
	var count = tiddlers.length;
	var i;
	for (i = 0; i < count; i++) {
		var tiddler = tiddlers[i];
		tiddler.forEachTiddlerSortValue = func(tiddler,context, undefined, undefined);
	}

	// Do the sorting
	tiddlers.sort(ascending ? this.sortAscending : this.sortDescending);

	// Delete the temporary property that holds the sortValue.	
	for (i = 0; i < tiddlers.length; i++) {
		delete tiddlers[i].forEachTiddlerSortValue;
	}
};


// Internal.
//
config.macros.forEachTiddler.trace = function(message) {
	displayMessage(message);
};

// Internal.
//
config.macros.forEachTiddler.traceMacroCall = function(place,macroName,params) {
	var message ="<<"+macroName;
	for (var i = 0; i < params.length; i++) {
		message += " "+params[i];
	}
	message += ">>";
	displayMessage(message);
};


// Internal.
//
// Creates an element that holds an error message
// 
config.macros.forEachTiddler.createErrorElement = function(place, exception) {
	var message = (exception.description) ? exception.description : exception.toString();
	return createTiddlyElement(place,"span",null,"forEachTiddlerError","<<forEachTiddler ...>>: "+message);
};

// Internal.
//
// @param place [may be null]
//
config.macros.forEachTiddler.handleError = function(place, exception) {
	if (place) {
		this.createErrorElement(place, exception);
	} else {
		throw exception;
	}
};

// Internal.
//
// Encodes the given string.
//
// Replaces 
//	 "$))" to ">>"
//	 "$)" to ">"
//
config.macros.forEachTiddler.paramEncode = function(s) {
	var reGTGT = new RegExp("\\$\\)\\)","mg");
	var reGT = new RegExp("\\$\\)","mg");
	return s.replace(reGTGT, ">>").replace(reGT, ">");
};

// Internal.
//
// Returns the given original path (that is a file path, starting with "file:")
// as a path to a local file, in the systems native file format.
//
// Location information in the originalPath (i.e. the "#" and stuff following)
// is stripped.
// 
config.macros.forEachTiddler.getLocalPath = function(originalPath) {
	// Remove any location part of the URL
	var hashPos = originalPath.indexOf("#");
	if(hashPos != -1)
		originalPath = originalPath.substr(0,hashPos);
	// Convert to a native file format assuming
	// "file:///x:/path/path/path..." - pc local file --> "x:\path\path\path..."
	// "file://///server/share/path/path/path..." - FireFox pc network file --> "\\server\share\path\path\path..."
	// "file:///path/path/path..." - mac/unix local file --> "/path/path/path..."
	// "file://server/share/path/path/path..." - pc network file --> "\\server\share\path\path\path..."
	var localPath;
	if(originalPath.charAt(9) == ":") // pc local file
		localPath = unescape(originalPath.substr(8)).replace(new RegExp("/","g"),"\\");
	else if(originalPath.indexOf("file://///") === 0) // FireFox pc network file
		localPath = "\\\\" + unescape(originalPath.substr(10)).replace(new RegExp("/","g"),"\\");
	else if(originalPath.indexOf("file:///") === 0) // mac/unix local file
		localPath = unescape(originalPath.substr(7));
	else if(originalPath.indexOf("file:/") === 0) // mac/unix local file
		localPath = unescape(originalPath.substr(5));
	else // pc network file
		localPath = "\\\\" + unescape(originalPath.substr(7)).replace(new RegExp("/","g"),"\\");	
	return localPath;
};

// ---------------------------------------------------------------------------
// Stylesheet Extensions (may be overridden by local StyleSheet)
// ---------------------------------------------------------------------------
//
setStylesheet(
	".forEachTiddlerError{color: #ffffff;background-color: #880000;}",
	"forEachTiddler");

//============================================================================
// End of forEachTiddler Macro
//============================================================================


//============================================================================
// String.startsWith Function
//============================================================================
//
// Returns true if the string starts with the given prefix, false otherwise.
//
version.extensions["String.startsWith"] = {major: 1, minor: 0, revision: 0, date: new Date(2005,11,20), provider: "http://tiddlywiki.abego-software.de"};
//
String.prototype.startsWith = function(prefix) {
	var n =  prefix.length;
	return (this.length >= n) && (this.slice(0, n) == prefix);
};



//============================================================================
// String.endsWith Function
//============================================================================
//
// Returns true if the string ends with the given suffix, false otherwise.
//
version.extensions["String.endsWith"] = {major: 1, minor: 0, revision: 0, date: new Date(2005,11,20), provider: "http://tiddlywiki.abego-software.de"};
//
String.prototype.endsWith = function(suffix) {
	var n = suffix.length;
	return (this.length >= n) && (this.right(n) == suffix);
};


//============================================================================
// String.contains Function
//============================================================================
//
// Returns true when the string contains the given substring, false otherwise.
//
version.extensions["String.contains"] = {major: 1, minor: 0, revision: 0, date: new Date(2005,11,20), provider: "http://tiddlywiki.abego-software.de"};
//
String.prototype.contains = function(substring) {
	return this.indexOf(substring) >= 0;
};

//============================================================================
// Array.indexOf Function
//============================================================================
//
// Returns the index of the first occurance of the given item in the array or 
// -1 when no such item exists.
//
// @param item [may be null]
//
version.extensions["Array.indexOf"] = {major: 1, minor: 0, revision: 0, date: new Date(2005,11,20), provider: "http://tiddlywiki.abego-software.de"};
//
Array.prototype.indexOf = function(item) {
	for (var i = 0; i < this.length; i++) {
		if (this[i] == item) {
			return i;
		}
	}
	return -1;
};

//============================================================================
// Array.contains Function
//============================================================================
//
// Returns true when the array contains the given item, otherwise false. 
//
// @param item [may be null]
//
version.extensions["Array.contains"] = {major: 1, minor: 0, revision: 0, date: new Date(2005,11,20), provider: "http://tiddlywiki.abego-software.de"};
//
Array.prototype.contains = function(item) {
	return (this.indexOf(item) >= 0);
};

//============================================================================
// Array.containsAny Function
//============================================================================
//
// Returns true when the array contains at least one of the elements 
// of the item. Otherwise (or when items contains no elements) false is returned.
//
version.extensions["Array.containsAny"] = {major: 1, minor: 0, revision: 0, date: new Date(2005,11,20), provider: "http://tiddlywiki.abego-software.de"};
//
Array.prototype.containsAny = function(items) {
	for(var i = 0; i < items.length; i++) {
		if (this.contains(items[i])) {
			return true;
		}
	}
	return false;
};


//============================================================================
// Array.containsAll Function
//============================================================================
//
// Returns true when the array contains all the items, otherwise false.
// 
// When items is null false is returned (even if the array contains a null).
//
// @param items [may be null] 
//
version.extensions["Array.containsAll"] = {major: 1, minor: 0, revision: 0, date: new Date(2005,11,20), provider: "http://tiddlywiki.abego-software.de"};
//
Array.prototype.containsAll = function(items) {
	for(var i = 0; i < items.length; i++) {
		if (!this.contains(items[i])) {
			return false;
		}
	}
	return true;
};


} // of "install only once"

// Used Globals (for JSLint) ==============
// ... DOM
/*global 	document */
// ... TiddlyWiki Core
/*global 	convertUnicodeToUTF8, createTiddlyElement, createTiddlyLink, 
			displayMessage, endSaveArea, hasClass, loadFile, saveFile, 
			startSaveArea, store, wikify */
//}}}


/***
!Licence and Copyright
Copyright (c) abego Software ~GmbH, 2005 ([[www.abego-software.de|http://www.abego-software.de]])

Redistribution and use in source and binary forms, with or without modification,
are permitted provided that the following conditions are met:

Redistributions of source code must retain the above copyright notice, this
list of conditions and the following disclaimer.

Redistributions in binary form must reproduce the above copyright notice, this
list of conditions and the following disclaimer in the documentation and/or other
materials provided with the distribution.

Neither the name of abego Software nor the names of its contributors may be
used to endorse or promote products derived from this software without specific
prior written permission.

THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND ANY
EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT
SHALL THE COPYRIGHT OWNER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT,
INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED
TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR
BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN
CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN
ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH
DAMAGE.
***/
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

In FDA regulations this refered to as 'The Act'

See: http://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act
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
|Symbol|Command|h
|$\large \displaystyle X \cdot Y$|X \\cdot Y|
|$\large \displaystyle \frac{d}{dx}\left(x^2\right) = 2x$|\\frac{d}{dx}\left(x^2\\right) = 2x|
|$\large \displaystyle \int 2x\,dx = x^2+C$|\\int 2x\,dx = x^2+C|
|$\large \displaystyle \int^5_1 2x\,dx = 24$|\\int^5_1 2x\,dx = 24|
|$\large \displaystyle \int^5_1 2x\,dx = 24$|\\displaystyle\int^5_1 2x\,dx = 24|
|$\large \displaystyle \frac{\partial^2U}{\partial x^2} + \frac{\partial^2U}{\partial y^2}$|\\frac{\\partial^2U}{\\partial x^2} + \\frac{\\partial^2U}{\\partial y^2}|
|$\large \displaystyle \frac{1}{4\pi}\oint_\Sigma\frac{1}{r}\frac{\partial U}{\partial n} ds$|\\displaystyle \\frac{1}{4\pi} \\oint_\\Sigma\\frac{1}{r}\frac{\partial U}{\partial n} ds|
/***
|''Name''|TiddlySpaceRevisionView|
|''Description''|Show tiddler revisions in a stack of cards view|
|''Author''|BenGillies|
|''Version''|0.2.0|
|''Status''|beta|
|''Source''|http://github.com/TiddlySpace/tiddlyspace|
|''CodeRepository''|http://github.com/TiddlySpace/tiddlyspace|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''CoreVersion''|2.6.0|
|''Requires''|TiddlyWebAdaptor|
!Usage
The viewRevisions macro can be attached to any element, which should be passed
in as a parameter.

For example:

&lt;&lt;viewRevisions page:10 link:"<<view modified date>>"&gt;&gt;

would show the revisions "stack of cards" view, 10 at a time, when the modified
date is clicked.
!Code
***/
//{{{
(function($) {

var me = config.macros.viewRevisions = {
	revisionTemplate: "RevisionTemplate",
	revSuffix: " [rev. #%0]", // text to append to each tiddler title
	defaultPageSize: 5, // default number of revisions to show
	defaultLinkText: "View Revisions", // when there's nothing else to use
	offsetTop: 30, // in px
	offsetLeft: 10, // in px
	shiftDownDelay: 50, // in ms
	visibleSlideAmount: 20, // amount of revisions to show on left hand edge after sliding
	zIndex: 100, // default z-index
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		params = paramString.parseParams(null, null, true)[0];
		var tiddlerElem = story.findContainingTiddler(place);

		var revButton;
		var pageSize = parseInt(params.page[0], 10) || me.defaultPageSize;
		var linkObj = params.link ? params.link[0] || me.defaultLinkText : false;
		if(linkObj) {
			revButton = $('<span class="button openRevisions" />')
				.appendTo(place);
			wikify(linkObj, revButton[0], null, tiddler);
		} else {
			revButton = place;
		}

		$(revButton).click(function() {
			if (!$(tiddlerElem).hasClass("revisions")) {
				me.showRevisions(tiddlerElem, tiddler, pageSize);
			} else {
				me.closeRevisions(tiddlerElem);
			}
		});
	},

	// initialisation for revision view
	showRevisions: function(tiddlerElem, tiddler, pageSize) {
		var context = {
			host: tiddler.fields["server.host"],
			workspace: tiddler.fields["server.workspace"]
		};
		$(tiddlerElem).addClass("revisions").attr("revName", tiddler.title);
		// ensure toolbar commands deactivate RevisionsView
		$("a", ".toolbar", tiddlerElem).each(function(index, btn) {
			var _onclick = btn.onclick;
			btn.onclick = function(e) {
				me.closeRevisions(tiddlerElem);
				_onclick.apply(this, arguments);
			};
		});
		// ensure default action deactivates RevisionsView
		var _ondblclick = tiddlerElem.ondblclick;
		tiddlerElem.ondblclick = function(e) {
			me.closeRevisions(tiddlerElem);
			_ondblclick.apply(this, arguments);
		};
		var type = tiddler.fields["server.type"];
		var adaptor = new config.adaptors[type]();
		var userParams = {
			tiddlerElem: tiddlerElem,
			pageSize: pageSize,
			title: tiddler.title
		};
		me.createCloak(tiddlerElem);
		adaptor.getTiddlerRevisionList(tiddler.title, null, context, userParams,
				function(context, userParams) {
					// strip the current revision
					context.revisions.shift();
					me.expandStack(context, userParams);
				});
	},

	// fetch the actual revision and put it in the tiddler div
	showRevision: function(place, revision, callback) {
		var context = {
			host: revision.fields["server.host"],
			workspace: revision.fields["server.workspace"]
		};
		var userParams = {
			revElem: place
		};
		var type = revision.fields["server.type"];
		var adaptor = new config.adaptors[type]();
		var revNo = revision.fields["server.page.revision"];
		adaptor.getTiddlerRevision(revision.title, revNo, context, userParams,
			function(context, userParams) {
				var tiddler = context.tiddler;
				tiddler.title += me.revSuffix
					.format([$(place).attr("revision")]);
				tiddler.fields.doNotSave = true;
				if (store.getTiddler(tiddler.title)) {
					store.deleteTiddler(tiddler.title);
				}
				store.addTiddler(tiddler);

				//now, populate the existing div
				var revElem = userParams.revElem;
				$(revElem).attr("id", story.tiddlerId(tiddler.title));
				$(revElem).attr("refresh", "tiddler");
				var getTemplate = function() {
					var themeName = config.options.txtTheme;
					if (themeName) {
						return store.getTiddlerSlice(themeName,
							me.revisionTemplate) || me.revisionTemplate ||
							"ViewTemplate";
					} else {
						return (store.getTiddler(me.revisionTemplate)) ?
							me.revisionTemplate : "ViewTemplate";
					}
				};
				var template = getTemplate();
				story.refreshTiddler(tiddler.title, template, true);
				callback(tiddler);
			});
	},

	createCloak: function(promoteElem) {
		var el = $(promoteElem);
		// cache styles for resetting later
		el.data({
			top: el.css("top"),
			left: el.css("left"),
			zIndex: el.css("z-index")
		});

		$('<div class="revisionCloak" />').css("z-index", me.zIndex)
			.click(function() {
				me.closeRevisions(promoteElem);
			})
			.appendTo(document.body);

		el.css("z-index", me.zIndex + 1);
	},

	// clean up, removing all evidence of revision view
	closeRevisions: function(promoteElem) {
		var el = $(promoteElem);
		// revert the original tiddler back to its previous state
		el.removeAttr("revName").removeClass("revisions").css({
			top: el.data("top"),
			left: el.data("left"),
			zIndex: el.data("zIndex")
		});

		// remove any revisions still in the store
		var revisions = $(".revisions");
		revisions.each(function(index, revision) {
			var revAttributes = revision.attributes;
			if ((revAttributes.revname) &&
					(revAttributes.revision)) {
				var revName = revAttributes.revname.value;
				var revNo = revAttributes.revision.value;
				var title = revName + me.revSuffix.format([revNo]);

				if (store.getTiddler(title)) {
					store.deleteTiddler(title);
				}
			}
		});

		// delete the previous revisions
		revisions.remove();

		// remove the cloak
		$(".revisionCloak").remove();
	},

	// calback from getting list of revisions
	expandStack: function(context, userParams) {
		var pageSize = userParams.pageSize;

		var from = userParams.from || 0;
		var tiddlerElem = userParams.tiddlerElem;

		userParams.defaultHeight = $(tiddlerElem).height();
		userParams.defaultWidth = $(tiddlerElem).width();
		if (from < context.revisions.length) {
			me.displayNextRevision(tiddlerElem, userParams, context, from,
				from + pageSize - 1);
		}
	},

	// place the next div above and behind the previous one
	displayNextRevision: function(tiddlerElem, userParams, context, from, to) {
		var revision = context.revisions[from];
		var callback = function() {
			var revText = revBtn.getRevisionText(tiddlerElem, revision);
			tiddlerElem = me.createRevisionObject(tiddlerElem, context,
				userParams, revText);
			$(tiddlerElem)
				.attr("revision", (context.revisions.length - from));
			if ((from < to) && ((from + 1) < context.revisions.length)){
				me.displayNextRevision(tiddlerElem, userParams, context,
					from + 1, to);
			} else if ((context.revisions.length - 1) > to) {
				me.showMoreButton(tiddlerElem, context, userParams, to + 1);
			}
		};
		me.shiftVisibleDown(userParams.title, callback);
	},

	createRevisionObject: function(tiddlerElem, context, userParams, text) {
		var newPosition = me.calculatePosition(tiddlerElem, context);
		return $('<div class="revisions tiddler" />')
			.css({
				position: "absolute",
				top: newPosition.top,
				left: newPosition.left,
				"z-index": me.zIndex + 1,
				height: userParams.defaultHeight,
				width: userParams.defaultWidth
			})
			.attr("revName", userParams.title)
			.append(text)
			.insertBefore(tiddlerElem);
	},

	// move the already present revisions down by 1 to fit the next one in
	shiftVisibleDown: function(title, callback) {
		var revisions = $("[revName='%0'].revisions".format([title]));
		var revisionCount = revisions.length;

		$(revisions).animate({top: "+=" + me.offsetTop},
				me.shiftDownDelay, function() {
					revisionCount -= 1;
					if ((callback) && (!revisionCount)) {
						callback();
					}
				});
	},

	// where we put the new revision
	calculatePosition: function(elem, context) {
		var offset = $(elem).offset();
		var currentPosition = $(elem).position();
		var newPosition = {
			top: currentPosition.top - me.offsetTop
		};
		if ((context.restrictLeft) ||
				((offset.left - me.offsetLeft) <
				$("#contentWrapper").offset().left)) {
			newPosition.left = $(elem).position().left;
			context.restrictLeft = true;
		} else {
			newPosition.left = currentPosition.left - me.offsetLeft;
		}
		return newPosition;
	},

	// equivalent of displayNextRevision, but for the more button
	showMoreButton: function(tiddlerElem, context, userParams, moreIndex) {
		userParams.from = moreIndex + 1;
		me.shiftVisibleDown(userParams.title, function() {
			var btn = me.createRevisionObject(tiddlerElem, context, userParams,
				"");

			var more = createTiddlyButton(btn[0], "more...", "show more revisions",
				function() {
					if ($(".viewRevision").length) {
						return;
					}
					userParams.tiddlerElem = btn[0];
					$(btn).text("")
						.append(revBtn
							.getRevisionText(btn[0], context.revisions[moreIndex]))
						.attr("revision", context.revisions.length - moreIndex);
					me.expandStack(context, userParams);
				});
			$(more).css("float", "right");
		});
	},

	stripRevFromTitle: function(revisionTitle) {
		return revisionTitle.split(/ ?\[rev\. #[0-9]+\]$/)[0];
	},

	onClickRevision: function(revElem, revision, callback) {
		// don't do anything if we are still loading
		if ($(".revisions").hasClass("loading")) {
			return null;
		}

		var origTitle = me.stripRevFromTitle(revision.title);
		if ($(revElem).hasClass("viewRevision")) {
			$(".revisions").addClass("loading");
			me.slideIn(revElem, revision, origTitle, function() {
				store.deleteTiddler(revision.title);
				revision.title = origTitle;
				$(revElem).text("").append(revBtn.getRevisionText(revElem,
						revision))
					.removeAttr("tags").removeAttr("tiddler")
					.removeAttr("refresh").removeAttr("template")
					.removeAttr("id");
				$(".revisions").removeClass("loading");
				if (callback) {
					callback();
				}
			});
			$(revElem).removeAttr("prevPos").removeClass("viewRevision");
		} else {
			var viewRevision = function() {
				var prevPos = $(revElem).position().left;
				$(revElem).addClass("viewRevision").attr("prevPos", prevPos);
				$(".revisions").addClass("loading");
				me.showRevision(revElem, revision, function(rev) {
					me.slideOut(revElem, rev, origTitle, function() {
						$(".revisions").removeClass("loading");
					});
				});
			};
			// make sure another revision isn't already out
			if ($(".viewRevision").length) {
				var newRevElem = $(".viewRevision")[0];
				var newRevision = store.getTiddler($(newRevElem)
					.attr("tiddler"));
				me.onClickRevision(newRevElem, newRevision, viewRevision);
			} else {
				viewRevision();
			}
		}
	},

	slideOut: function(revElem, revision, title, callback) {
		var leftMostPos = $("[revName='%0'].revisions".format([title]))
			.offset().left;
		var width = $(revElem).width();
		var originalLeftPos = $(story.getTiddler(title))
			.position().left;

		var slideAmount = leftMostPos + width - me.visibleSlideAmount;
		$("[revName='%0'].revisions:not(.viewRevision)".format([title]))
			.animate({left: "-=" + slideAmount}, 1000);
		$(revElem)
			.attr("baseHeight", $(revElem).css("height"))
			.css("height", "auto")
			.animate({left: originalLeftPos}, 1000, callback);
	},

	slideIn: function(revElem, revision, title, callback) {
		var slideAmount = $(revElem).offset().left -
			$(story.getTiddler(title)).offset().left;
		var origRevPos = $(revElem).attr("prevPos");

		$("[revName='%0'].revisions:not(.viewRevision)".format([title]))
			.animate({left: "+=" + slideAmount}, 1000);
		$(revElem).animate({left: origRevPos}, 1000, function() {
			$(revElem)
				.css("height", $(revElem).attr("baseHeight"))
				.removeAttr("baseHeight");
			callback();
		});
	}
};

var revBtn;
config.macros.slideRevision = revBtn = {
	btnText: "created by %0 at %1 on %2",
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		var btn = revBtn.getRevisionText(place, tiddler);
		$(place).append(btn);
	},

	getRevisionText: function(place, revision) {
		var text = revBtn.btnText.format([revision.modifier,
			revision.modified.formatString("0hh:0mm"),
			revision.modified.formatString("0DD MMM YYYY")]);
		var btn = $('<a href="javascript:;" class="button revButton" />')
			.text(text)
			.click(function() {
				var revElem = story.findContainingTiddler(this);
				me.onClickRevision(revElem, revision);
			});
		return btn;
	}
};

})(jQuery);
//}}}
Advanced product quality planning (or APQP) is a framework of procedures and techniques used to develop products in industry, particularly the automotive industry. It is quite similar to the concept of Design for Six Sigma ([[DFSS]]).
Intended use is the objective intent of the manufacturer or person(s) legally responsible for the labelling of devices and includes labeling claims, advertising amtter, and oral or written statements by such firms or their represenatives
[[StyleSheetTiddlySpace]]
List of tiddlers containing video fragments:

<<forEachTiddler
 where
 'tiddler.tags.contains("Video")'
 sortBy 
        'tiddler.title.toUpperCase()'
 script
 '
 function getFirstLine(s) {
 var m = s.match(/\s*(.*)/);
 return m != null && m.length >= 1 ? m[1] : "";
 }
 '
 write
 '"[["+tiddler.title+"]]\n"' 

>>
''4.1 General requirements''
The organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard.

The organization shall
a) identify the processes needed for the quality management system and their application throughout theorganization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) monitor, measure and analyse these processes, and
f) implement actions necessary to achieve planned results and maintain the effectiveness of these processes. These processes shall be managed by the organization in accordance with the requirements of this

International Standard.
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system (see 8.5.1).

NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
''7.2.2 Review of requirements related to the product''

The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that:
a) product requirements are defined and documented,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be
confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are
amended and that relevant personnel are made aware of the changed requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review
can cover relevant product information such as catalogues or advertising material.
@@Please do not modify this tiddler; it was created automatically upon space creation.@@
When a mode of operation has an optional high-level control and the control is activated, the equipement:
* shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure rate) at the measurement point specified in [[1020.32(d)(3)|CFR 1020.32 Fluoroscopic equipment (d)(3) Measuring compliance]].
* Special means of activation of high-level controls shall be required:
** The high-level control shall be operable only when continuous manual activation is provided by the operator.
** A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed
<html>
<img src="/static/files/Work/Dirk-Jan/dsn.jpg" width="150" style="float:left;margin:5px 20px 5px 0" />
Dirk-Jan Swagerman is a result driven innovation and development director and coach. Capable of getting things done. Enjoying people, technology and multi site multi disciplinary innovation and development. Fulfilled software architecture, functional  management and project leading roles. Practical hands on manager with process affinity. Conceptual and creative thinker. Demonstrated ability to build strong cross site and cross functional relationships. Strong experience with Czech and United States work cultures. My goal is learn and expand my in company entrepreneurial business skills. This was the reason to start with Master of Business Innovation program at Tias Nimbas in March 2010. I completed this program in June 2012. In the context of the study i started to host my own tiddlyspace for notekeeping and bookmarking on different subjects.
<br>
<br>
After the MBI study I started to coach startups using my <a href="http://mbi.dirkjanswagerman.nl">Master of Business Innovation</a> website as a resource for learning and reference. If you are interest in a free first coaching session please contact me at <a href="mailto:djswagerman@chello.nl">Dirk-Jan Swagerman</a> or through my linkedin account below. You can read about the coaching approach <a href="http://blog.dirkjanswagerman.nl/innovation-coaching-for-startups/">here.</a> 
<br>
<br>
<br>
<br>
<iframe allowtransparency="true" frameborder="0" scrolling="no"
  src="//platform.twitter.com/widgets/follow_button.html?screen_name=djswagerman"
  style="width:300px; height:20px;"></iframe>
<br>
<a href="http://nl.linkedin.com/in/djswagerman">
      
          <img src="http://www.linkedin.com/img/webpromo/btn_viewmy_160x33.png" width="160" height="33" border="0" alt="View Dirk Jan Swagerman's profile on LinkedIn">
        
    </a>
</html>
<<forEachTiddler
 where
 'tiddler.tags.contains("Term")'
 sortBy 
        'tiddler.title.toUpperCase()'
 script
 '
 function getFirstLine(s) {
 var m = s.match(/\s*(.*)/);
 return m != null && m.length >= 1 ? m[1] : "";
 }
 '
 write
 '"|[["+tiddler.title+"]]"+"|"+ getFirstLine(tiddler.text)+"|\n"' 

>>
A ''Top-Down Inspection'' is the FDA's latest inspection strategy in which inspectors are taught to evaluate the quality system and sampling quality system records.

The "top-down" approach begins each subsystem review with an evaluation of whether the firm has addressed the basic requirements in that subsystem by defining and documenting appropriate procedures. This is followed by an analysis of whether the firm has implemented the requirements of that subsystem.
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width="30" height="30">
	<g stroke="none" stroke-opacity="1" stroke-dasharray="none" fill="none" fill-opacity="1">
		<g>
			<path d="M 452.1094 421.2422 L 450 421.2422 L 450 423 L 487.9688 423 L 487.9688 421.2422 L 485.8595 421.2422 
			L 485.8595 377.29688 L 487.9688 377.29688 L 487.9688 375.53906 L 485.8595 375.53906 
			C 485.8595 375.53906 481.12463 371.59341 473.02023 370.52802 C 472.6824 368.9689 471.72098 366.75 468.9844 366.75 
			C 466.24783 366.75 465.28638 368.9689 464.94864 370.52802 
			C 456.84418 371.59341 452.1094 375.53906 452.1094 375.53906 L 450 375.53906 L 450 377.29688 L 452.1094 377.29688 
			Z M 467.12247 370.32086 L 467.12247 370.32086 C 467.3805 369.42395 467.90762 368.50781 468.9844 368.50781 
			C 470.0612 368.50781 470.5883 369.42395 470.84634 370.32086 
			C 470.24136 370.2848 469.62054 370.26562 468.9844 370.26562 
			C 468.34827 370.26562 467.72748 370.2848 467.12247 370.32086 Z M 454.21875 420.92804 L 454.21875 420.92804 
			C 455.46762 420.42087 456.32816 419.35281 456.32816 418.11716 L 456.32816 377.29688 L 458.4375 377.29688 
			L 458.4375 421.2422 L 454.21875 421.2422 Z M 460.5469 420.92804 L 460.5469 420.92804 
			C 461.79578 420.42087 462.65625 419.35281 462.65625 418.11716 L 462.65625 377.29688 L 464.76566 377.29688 
			L 464.76566 421.2422 L 460.5469 421.2422 Z M 466.87503 420.92804 L 466.87503 420.92804 
			C 468.1239 420.42087 468.9844 419.35281 468.9844 418.11716 L 468.9844 377.29688 L 471.09378 377.29688 
			L 471.09378 421.2422 L 466.87503 421.2422 Z M 473.2032 420.92804 L 473.2032 420.92804 
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			L 477.4219 421.2422 L 473.2032 421.2422 Z M 479.5313 420.92804 L 479.5313 420.92804 
			C 480.78018 420.42087 481.64066 419.35281 481.64066 418.11716 L 481.64066 377.29688 L 483.75006 377.29688 
			L 483.75006 421.2422 L 479.5313 421.2422 Z" fill="black" class="glyph"/>
		</g>
	</g>
</svg>
[[Management with executive responsibility]] shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

!Attention points
* Problems and issues identified should be written down in the [[Management Review Report]].
* The review should identify any changes to the quality policy procedure
* Each review should be numbered with a logical numbering system
* The report might have sections:
** Quality System
** Quality Procedure
** Quality Plan
** Qualtity System Procedures
* Only include those issues that significantly impact the [[Quality System]]
//5) Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently ''rectangular'' image receptors.//

For x-ray systems manufactured on or after June 10, 2006, the following applies:

(i) Neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID.

(ii) The error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.
Type the text for 'New Tiddler'
''7.4.3 Verification of purchased product''

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

Records of the verification shall be maintained (see 4.2.4).

Examples of verification
* Incoming inspection
** 100% full inspection or
** based on sampling plan (AQL) Acceptance Quality Limit as defined in ISO 2859-1
** First article inspection or ….
**  Material certificates: evidence of conformity to supplier release tests
*  Who has put the inspection flag on? And how is it un-flagged?
* Always again risk based
* What happens if does not conform? Corrective actions?
• Is the verification independent from assembly personnel?
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Absurd Conditions//'' are those testing activities that are performed even though there is little likelyhood the conditions will occur during normal medical device use.
There are several major differences:
* FDA regulations are the federal law!
* [[ISO 9000]] consist of volontary quality standards, which manufacturers comply and document with periodic internal and external auditing
* FDA's management responsibility, management representative, management review, design controls and complaint regulations are more prescriptive and specific than [[ISO 9000]]
* [[ISO 9000]] has no failure-reporting requirement, recall requirement and in fact no effectiveness requirement
* On the other hand the FDA has limited control over personnel, largely personnel assesment, approval for their position, and training requirements. [[ISO 9000]] expects the personal department to be fully controlled.
* FDA has no control over a manufacturers financial department assuming its not the purchasing arm of the firm. [[ISO 9000]] expects finance to be fully controlled.
* FDA has little oversight over marketing & sales.
FDA compliance will always overshadow voluntary [[ISO 9001]] certification expectations.
An ''advisory notice'' is notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary
information and/or to advise what action should be taken in
* the use of a medical device,
* the modification of a medical device,
* the return of the medical device to the organization that supplied it, or
* the destruction of a medical device
NOTE Issue of an advisory notice might be required to comply with national or regional regulations.
A ''Track II Inspection'' is a complete audit of a manufacturers quality system performed by the FDA every four years.
Each manufacturer shall establish and maintain an [[Adequate Organizational Structure]] to ensure that devices are designed and produced in accordance with the requirements of this part.

# ''Responsibility and authority''
## Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
# ''Resources''
## Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.
# ''Management representative''
## [[Management with executive responsibility]] shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:
### Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
### Reporting on the performance of the quality system to management with executive responsibility for review.

!Attention points
* Management is regarded as the source of botht authority and responsibility. Delegating responsibilities will not deflect the FDA's focus to management.
* The size of the quality organization needs to scale with the size of the organization.
* The FDA understands that manufacturers of different sizes will establish different [[Quality Policy]]
Quick Response Quality Control is a best practice for problem solving in an organisation.
These regulations implement the FDA's responsibilities for and authority over devices identified by the FDA that present substantial deception or an unreasonable and substantial risk of illness or injury
''Clause 3 Terms & definitions''

*  Wherever the term “product” occurs, it can also mean “service”
*  Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to “related services as supplied by the
organization”.
*  Question: can you give examples of advisory notices?
In the [[FDA Regulations]] a ''Device Master Record'' ([[DMS]]) means a compilation of records containing the prodedures and specifications for a finished device.

Compare [[Device Master File]]

Note:
Question: The difference between a ''//record//'' and a ''//file//'' is that the record is about the actual device in production and the file is about the actual device during design???
In the FDA Regulations the abreviation CFR stands for Code of Federal Regulations.

CFR Regulations Described:
<<forEachTiddler
    where
        'tiddler.tags.contains("CFR")'
    sortBy 
         'tiddler.title.toUpperCase()'
   write
         '"* [["+tiddler.title+"]]" + "\n"'

>>
Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.
!Attention Points
* Design Controls do not apply to a 'concept' phase of a product
* <<tiddler [[Product Proposal]]>>
* Management should document the identification of medical devices subject to design controls.
** Indicated by dates when the design efforts where initiated
** If there are devices that predate design control regulatations
** New devices since regulations
** Modified devices since regulations
* For each device the elements of design planning should be described.
!Management responsibilities
* Management should procedurally identify appropriate design control departments and activities
** Including design and development planning
** Review responsibilities for each department and activity
** May be 1 page or complex document depending on project size
* Management should identify project activities, stages, departments and participants
** Often this is done with [[Design Teams]]. A name or numbering system for each product design and document being controlled
/***
|''Name''|DeliciousImportPlugin|
|''Description''|import your Delicious links into TiddlyWiki|
|''Authors''|BenGillies|
|''Version''|.2|
|''Status''|unstable|
|''Source''|http://svn.tiddlywiki.org/Trunk/contributors/BenGillies/Plugins/Delicious/tiddlers/DeliciousImportPlugin.js|
|''CodeRepository''|http://svn.tiddlywiki.org/Trunk/contributors/BenGillies/Plugins/Delicious/|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
!Usage
{{{
<<deliciousImport username>>
}}}
Will import up to 100 (limit set by delicious) of your latest delicious feeds into your TiddlyWiki.
!To Do
*Convert into an adaptor
!Code
***/
//{{{
(function($) {
if (!version.extensions.DeliciousImportPlugin) {
version.extensions.DeliciousImportPlugin = { installed: true };

var importer
importer = config.macros.deliciousImport = {
	loadingMsg: "loading bookmarks...",
	noUserErr: "Error: No username specified.",
	uri: "http://feeds.delicious.com/v2/json/%0?count=10000&callback=%1",
	bookmarkletTemplate: '!URL\n%0\n\n!Description\n%1',
	handler:  function(place, macroName, params, wikifier, paramString, tiddler) {
		var username = params[0] || "";

		var btn = $("<button />").text("Import Bookmarks")
			.click(function() {
				if (username) {
					$(".deliciousResult").text(importer.loadingMsg);
					$('<script type="text/javascript" />')
						.attr("src", importer.uri.format([username,
							"config.macros.deliciousImport.jsonpCallback"]))
						.appendTo(place);
				} else {
					$(".deliciousResult").text(importer.noUserErr);
				}
			}).appendTo(place);
		$('<div class="deliciousResult" />').appendTo(place);
	},
	jsonpCallback: function(bookmarks) {
		var list = $("<ul />");
		$(".deliciousResult").text("").append(list);



                var workspace = config.defaultCustomFields['server.workspace'];
                workspace = workspace.replace ("bags/","");
                workspace = workspace.replace ("_public","");

		for(var i = 0; i < bookmarks.length; i++) {
			var bookmark = bookmarks[i];
			var title = bookmark.d;
			var modifier = bookmark.a;
			var tags = bookmark.t;
			tags.pushUnique("bookmark");
			var text = importer.bookmarkletTemplate.format([
				bookmark.u, bookmark.n]);
			var fields = {};
			if (config.defaultCustomFields) {
				merge(fields, config.defaultCustomFields);
			}

//                        if (tags.indexOf (workspace) != -1) {

			        if (!store.getTiddler(title)) {
				        store.saveTiddler(title, title, text, modifier, null, tags,
					         fields, false);
            			}
//                        }

			var linkPlace = $("<li />").appendTo(list);
			createTiddlyLink(linkPlace[0], title, true);
		}
		autoSaveChanges(true);
	}
};

}
})(jQuery);
//}}}
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] the ''//Master Verification//'' are documented functions, conditions, or capabilities that a medical device must meet or possess to satisfy a user's need, standard or regulatory expectations.
A [[SiteIcon|SiteIcon tiddler]]@glossary helps provide some identity to your space.  Ideally it'd be a square and a minimum of 48*48 pixels size.  You can upload your site icon using the uploader below.

<<binaryUploadPublic title:SiteIcon>>
In FDA regulation, general controls include:
# An establishments FDA registration form [[FDA 2891]]
# Product listing form [[FDA 2892]]
# Compliance with FDA's [[Good Manufacturing Practice]] regulation, now called [[Quality System Regulations]]
# Adverse reporting or FDA's [[Medical Device Reporting Regulations]]
/***
|''Name''|TiddlyWebConfig|
|''Description''|configuration settings for TiddlyWebWiki|
|''Author''|FND|
|''Version''|1.3.2|
|''Status''|stable|
|''Source''|http://svn.tiddlywiki.org/Trunk/association/plugins/TiddlyWebConfig.js|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''Requires''|TiddlyWebAdaptor ServerSideSavingPlugin|
|''Keywords''|serverSide TiddlyWeb|
!Code
***/
//{{{
(function($) {

if(!config.extensions.ServerSideSavingPlugin) {
	throw "Missing dependency: ServerSideSavingPlugin";
}
if(!config.adaptors.tiddlyweb) {
	throw "Missing dependency: TiddlyWebAdaptor";
}

if(window.location.protocol != "file:") {
	config.options.chkAutoSave = true;
}

var adaptor = tiddler.getAdaptor();
var recipe = tiddler.fields["server.recipe"];
var workspace = recipe ? "recipes/" + recipe : "bags/common";

var plugin = config.extensions.tiddlyweb = {
	host: tiddler.fields["server.host"].replace(/\/$/, ""),
	username: null,
	status: {},

	getStatus: null, // assigned later
	getUserInfo: function(callback) {
		this.getStatus(function(status) {
			callback({
				name: plugin.username,
				anon: plugin.username ? plugin.username == "GUEST" : true
			});
		});
	},
	hasPermission: function(type, tiddler) {
		var perms = tiddler.fields["server.permissions"];
		if(perms) {
			return perms.split(", ").contains(type);
		} else {
			return true;
		}
	}
};

config.defaultCustomFields = {
	"server.type": tiddler.getServerType(),
	"server.host": plugin.host,
	"server.workspace": workspace
};

// modify toolbar commands

config.shadowTiddlers.ToolbarCommands = config.shadowTiddlers.ToolbarCommands.
	replace("syncing ", "revisions syncing ");

config.commands.saveTiddler.isEnabled = function(tiddler) {
	return plugin.hasPermission("write", tiddler) && !tiddler.isReadOnly();
};

config.commands.deleteTiddler.isEnabled = function(tiddler) {
	return !readOnly && plugin.hasPermission("delete", tiddler);
};

// hijack option macro to disable username editing
var _optionMacro = config.macros.option.handler;
config.macros.option.handler = function(place, macroName, params, wikifier,
		paramString) {
	if(params[0] == "txtUserName") {
		params[0] = "options." + params[0];
		var self = this;
		var args = arguments;
		args[0] = $("<span />").appendTo(place)[0];
		plugin.getUserInfo(function(user) {
			config.macros.message.handler.apply(self, args);
		});
	} else {
		_optionMacro.apply(this, arguments);
	}
};

// hijack isReadOnly to take into account permissions and content type
var _isReadOnly = Tiddler.prototype.isReadOnly;
Tiddler.prototype.isReadOnly = function() {
	return _isReadOnly.apply(this, arguments) ||
		!plugin.hasPermission("write", this);
};

var getStatus = function(callback) {
	if(plugin.status.version) {
		callback(plugin.status);
	} else {
		var self = getStatus;
		if(self.pending) {
			if(callback) {
				self.queue.push(callback);
			}
		} else {
			self.pending = true;
			self.queue = callback ? [callback] : [];
			var _callback = function(context, userParams) {
				var status = context.serverStatus || {};
				for(var key in status) {
					if(key == "username") {
						plugin.username = status[key];
						config.macros.option.propagateOption("txtUserName",
							"value", plugin.username, "input");
					} else {
						plugin.status[key] = status[key];
					}
				}
				for(var i = 0; i < self.queue.length; i++) {
					self.queue[i](plugin.status);
				}
				delete self.queue;
				delete self.pending;
			};
			adaptor.getStatus({ host: plugin.host }, null, _callback);
		}
	}
};
(plugin.getStatus = getStatus)(); // XXX: hacky (arcane combo of assignment plus execution)

})(jQuery);
//}}}
''6.2.2 Competence, awareness and training''

The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
NOTE National or regional regulations might require the organization to establish documented procedures for
identifying training needs.
/***
!Description
due to bug in nodejs tags within a pre tag are interpretted as html rather than text. This fixes that with one line of code.
***/
$(document).ready(function() {
//$("#text-html pre").each(function(i, el) { var html = $(el).html(); $(el).text(html) });
});
<!DOCTYPE html>
<html>
<head>
	<meta http-equiv="Content-Type" content="text/html;charset=utf-8">
	<title>Account</title>
	<link href="/bags/common/tiddlers/profile.css" type='text/css' rel='stylesheet' >
	<link href="/bags/common/tiddlers/admin.css" type='text/css' rel='stylesheet' >
	<link href="/bags/common/tiddlers/jquery-ui.custom.css" type='text/css' rel='stylesheet' >
</head>
<body>

<div id="container">
	<div class="main section">
		<a class="app" href="/">home</a>
		<div class="left">
		<div id="siteiconArea">
		<h2>User Icon</h2>
		<div>
			<img id="siteicon" class="siteicon">
			<form id="upload" method="POST" enctype="multipart/form-data">
				<input type="hidden" name="title" value="SiteIcon" />
				<input type="hidden" name="tags" value="excludeLists">
				<input type="hidden" name="csrf_token" class="csrf" />
				<input type="file" name="file" accept="image/*" />
				<input type="submit" value="upload" />
			</form>
			<div id="dropzone">Drop file here
				<img class="notloading" src="/bags/common/tiddlers/ajax-loader.gif" alt="submitting SiteIcon" />
			</div>
		</div>
		</div>
		<h2>Find Space</h2>
		<form class="spaceSearch">
			<input class="inputBox" type="text" placeholder="find space" />
			<a href="http://docs.tiddlyspace.com/What%20is%20a%20Space%3F" class="help"
				title="What is a space?">What is a space?</a>
			<button>view all</button>
		</form>
		<div class='list-container'>
			You are a member of the following spaces:
			<ul class='ts-space-search'>
			</ul>
		</div>
		<h2>Create New Space</h2>
		<form class="ts-spaces">
			<input class="inputBox" type="text" name="spacename" placeholder="space name"><span class="hostSuffix">.tiddlyspace.com</span>
			<input type="submit" value="Create Space" />
		</form>
		</div>
		<div class="right">
		<h2>Change Password</h2>
		<form class="ts-password">
			<input class="inputBox" placeholder="existing password" type="password" name="password">
			<input class="inputBox" placeholder="new password" type="password" name="new_password">
			<input class="inputBox" placeholder="new password"	type="password" name="new_password_confirm">
			<input type="submit" value="Change password">
		</form>
		<h2>OpenID</h2>
		<h3>Why OpenID?</h3>
		<a href="http://openid.net/"><img src="/bags/common/tiddlers/openid.png" alt="openid" ></a><br />
		Use just one username and password across hundreds of OpenID-enabled sites.<br />
		It's an open standard.<br />
		<a href="http://openid.net/what/">learn more</a>
		<ul class="ts-identities"></ul>
		<form class="ts-openid" target="_top">
			<div>
				Add an openid:
			</div>
			<input class="inputBox" type="text" name="openid" placeholder="your openid" />
			<input type="submit" value="Register" />
			<a href="http://openid.net/get-an-openid/" class="help"
			title="What is an open id?">What is an open id?</a>
		</form>
		</div>
		<div class="clear"></div>
	</div>
</div>
<script src="/bags/common/tiddlers/backstage.js"></script>
<script src='/bags/common/tiddlers/jquery.js'></script>
<script src='/bags/tiddlyspace/tiddlers/chrjs'></script>
<script src='/bags/common/tiddlers/chrjs.space'></script>
<script src='/bags/common/tiddlers/chrjs.users'></script>
<script src='/bags/common/tiddlers/chrjs.identities'></script>
<script src="/bags/common/tiddlers/jquery-ui.custom.js"></script>
<script src='/bags/common/tiddlers/jquery-form.js'></script>
<script src="/bags/common/tiddlers/siteiconupload.js"></script>
<script src='/bags/common/tiddlers/ts.js'></script>
<script src="/status.js"></script>
<script type="text/javascript">
/*
 * jQuery UI Autocomplete HTML Extension
 *
 * Copyright 2010, Scott González (http://scottgonzalez.com)
 * Dual licensed under the MIT or GPL Version 2 licenses.
 *
 * http://github.com/scottgonzalez/jquery-ui-extensions
 */
(function( $ ) {

var proto = $.ui.autocomplete.prototype,
	initSource = proto._initSource;

function filter( array, term ) {
	var matcher = new RegExp( $.ui.autocomplete.escapeRegex(term), "i" );
	return $.grep( array, function(value) {
		return matcher.test( $( "<div>" ).html( value.label || value.value || value ).text() );
	});
}

$.extend( proto, {
	_initSource: function() {
		if ( this.options.html && $.isArray(this.options.source) ) {
			this.source = function( request, response ) {
				response( filter( this.options.source, request.term ) );
			};
		} else {
			initSource.call( this );
		}
	},

	_renderItem: function( ul, item) {
		return $( "<li></li>" )
			.data( "item.autocomplete", item )
			.append( $( "<a></a>" )[ this.options.html ? "html" : "text" ]( item.label ) )
			.appendTo( ul );
	}
});

})( jQuery );

/***
_accounts application specific javascript
***/
var link;
ts.init(function(ts) {
	if(ts.user.anon) { // redirect to homepage when user not logged in
		window.location = ts.getHost();
	} else if(ts.user.name === ts.currentSpace){
		initSiteIconUpload(ts.user.name);
	} else {
		link = $("<a />").attr("href", ts.getHost(ts.user.name) + "/_account").text("Change User Icon");
		$("#siteiconArea div").empty().append(link);
	}
	$(".hostSuffix").text("." + ts.getHost("").split("//")[1]);
	ts.getSpaces(function(spaces) {
		$("<div class='info' />").text("You have " + spaces.length + " spaces.").insertBefore($(".spaceSearch")[0]);
		$("form.spaceSearch input").autocomplete({
			html: true,
			source: function(req, response) {
				ts.getSpaces(function(spaces) {
					var selected = [];
					for(var i = 0; i < spaces.length; i++) {
						var space = spaces[i];
						if(space.name.indexOf(req.term) > -1) {
							var host = ts.getHost(space.name) ;
							var img = host + "/SiteIcon";
							selected.push({
								value: space.name,
								label: '<a href="' + host + '" target="_parent" class="autocompleteLink"><img src="' + img + '" style="height:24px;width:auto;max-height:24px;max-width:24px;"/>' + space.name + '</a>'
							});
						}
					}
					response(selected);
				});
			},
			select: function(event, ui) {
				window.top.location = ts.getHost(ui.item.value);
			}
		});

		var $ul = $('.ts-space-search');
		$.each(spaces, function(i, space) {
			$ul.append($('<li/>').html($('<a/>').attr('href', space.uri)
				.text(space.name)));
		});

		$('form.spaceSearch button').click(function(ev) {
			$('.list-container').slideToggle('fast');
			ev.preventDefault();
			return false;
		});
	});
});

if(window != window.top) {
	$("html").addClass("iframeMode");
	$("a").live("click",function(ev) {
		$(ev.target).attr("target", "_parent");
	});
}
</script>
<!--[if lt IE 8]>
<script type="text/javascript" src="/bags/common/tiddlers/json2.js"></script>
<![endif]-->
</body>
</html>
version.extensions.ta = {
	//VERSION
	major: 0, 
	minor: 1, 
	revision: 0, 
	date: new Date(2006,5,24),
	name:"TableAggregate",
	author:"MarceloAdamatti",
	source:"http://adamatti.tiddlyspot.com/#TableAggregatePlugin"	
}
config.macros.ta = {
	counter:0,
	//PROCESS ROW
	processR:function(funcao,idDiv){
		var div = document.getElementById("div" + idDiv);
		var td = div.parentNode;
		while(td.tagName!="TD" && td.tagName!="TH"){
			td=td.parentNode;	
		}
		var tr = td.parentNode;
		for (var i=0;i<tr.childNodes.length;i++){
			var aux = tr.childNodes[i];
			if (aux.tagName=="TD" || aux.tagName=="TH") {	
				try{	
					var x=0;
					if(document.all){
						x = parseFloat(aux.innerText);			
					}else{
						x = parseFloat(aux.textContent);			
					}
					if (!isNaN(x))
						funcao.process(x);
				}catch(e){}
			}
		}
		div.innerHTML=funcao.resultado.toFixed(2);
	},
	//PROCESS COL
	processC:function(funcao,idDiv){
		var div = document.getElementById("div" + idDiv);
		var td = div.parentNode;
		while(td.tagName!="TD" && td.tagName!="TH")
			td=td.parentNode;		
		var coluna = td.cellIndex;
		var tbody = td.parentNode.parentNode;
		for (var i=0;i<tbody.childNodes.length;i++){	
			var tr = tbody.childNodes[i];
			var aux = tr.childNodes[coluna];
			if (aux.tagName=="TD" || aux.tagName=="TH") {	
				try{	
					var x=0;
					if(document.all){
						x = parseFloat(aux.innerText);			
					}else{
						x = parseFloat(aux.textContent);			
					}
					if (!isNaN(x))
						funcao.process(x);
				}catch(e){}
			}
		}
		div.innerHTML=funcao.resultado.toFixed(2);
	},
	//FUNCTIONS
	funcs:{
		avg:function() {
			this.qtd=0;
			this.somador=0;
			this.resultado=0;
			this.process=function (valor){
				this.somador+=parseFloat(valor);
				this.qtd++;
				this.resultado=(this.somador/this.qtd);
			}				
		},
		sum:function (){
			this.resultado=0;	
			this.process=function (valor){
				this.resultado+=valor;
			}	
		},
		mul:function (){
			this.resultado=0;	
			this.process=function (valor){
				if (this.resultado > 0 )
					this.resultado=this.resultado * valor;
				if (this.resultado==0)
					this.resultado=valor;
			}	
		},
		min: function(){
			this.resultado="";
			this.process=function (valor){
				if (this.resultado=="")
					this.resultado=valor;
				if (valor<=this.resultado)
					this.resultado=valor;
			}
		},
		max:function(){
			this.resultado="";
			this.process=function (valor){
				if (this.resultado=="")
					this.resultado=valor;
				if (valor>=this.resultado)
					this.resultado=valor;
			}
		},
		count: function(){
			this.resultado=0;
			this.process=function (valor){
				this.resultado+=1;
			}
		}
	},
	handler:function(place,macroName,params) {
		var rowCol = params[0].toUpperCase();
		var func = params[1].toLowerCase();
		var counter=++config.macros.ta.counter;
		place.innerHTML="<div id=div" + counter + "></div><iframe "
					  + "onload='{var o=new config.macros.ta.funcs." + func + "();"
					  + "config.macros.ta.process" + rowCol + "(o," + counter + ");}' "
					  + "style='display:none'>"
					  "<\/iframe>";
	}
};
Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
# As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
# Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

!Attention Points
There should be written procedures for:
* Identifying training needs
* Ensuring that all personnel are adequately trained to perform their assigned responsibilities
* Document the required training

Training efforts should concentrate on:
* Making employees aware of the quality system regulations
* Relating job functions to the manufacturers quality system
* Ensuring that employees are aware of device defects that may occur from the improper performance in their jobs
* Ensuring that employees with verification or validation fucntions are aware of defects and error that may be encounteed during the performance of their jobs.

Personnel will be expected to know the quality policy to exist and where it is located. TIPS:
* Send out links to the quality procedures before audits
* Have employees auditted on the locations of procedures electronically
/***
|Name|TagCloudPlugin|
|Source|http://www.TiddlyTools.com/#TagCloudPlugin|
|Version|1.7.0|
|Author|Eric Shulman|
|Original Author|Clint Checketts|
|License|http://www.TiddlyTools.com/#LegalStatements|
|~CoreVersion|2.1|
|Type|plugin|
|Description|present a 'cloud' of tags (or links) using proportional font display|
!Usage
<<<
{{{
<<cloud type action:... limit:... tag tag tag ...>>
<<cloud type action:... limit:... +TiddlerName>>
<<cloud type action:... limit:... -TiddlerName>>
<<cloud type action:... limit:... =tagvalue>>
}}}
where:
* //type// is a keyword, one of:
** ''tags'' (default) - displays a cloud of tags, based on frequency of use
** ''links'' - displays a cloud of tiddlers, based on number of links //from// each tiddler
** ''references'' - displays a cloud of tiddlers, based on number of links //to// each tiddler
* ''action:popup'' (default) - clicking a cloud item shows a popup with links to related tiddlers<br>//or//<br> ''action:goto'' - clicking a cloud item immediately opens the tiddler corresponding to that item
* ''limit:N'' (optional) - restricts the cloud display to only show the N most popular tags/links
* ''tag tag tag...'' (or ''title title title'' if ''links''/''references'' is used)<br>shows all tags/links in the document //except// for those listed as macro parameters
* ''+TiddlerName''<br>show only tags/links read from a space-separated, bracketed list stored in a separate tiddler.
* ''-TiddlerName''<br>show all tags/links //except// those read from a space-separated, bracketed list stored in a separate tiddler.
* ''=tagvalue'' (//only if type=''tags''//)<br>shows only tags that are themselves tagged with the indicated tag value (i.e., ~TagglyTagging usage)
//note: for backward-compatibility, you can also use the macro {{{<<tagCloud ...>>}}} in place of {{{<<cloud ...>>}}}//
<<<
!Examples
<<<
//all tags excluding<<tag systemConfig>>, <<tag excludeMissing>> and <<tag script>>//
{{{<<cloud systemConfig excludeMissing script>>}}}
{{groupbox{<<cloud systemConfig excludeMissing script>>}}}
//top 10 tags excluding<<tag systemConfig>>, <<tag excludeMissing>> and <<tag script>>//
{{{<<cloud limit:10 systemConfig excludeMissing script>>}}}
{{groupbox{<<cloud limit:10 systemConfig excludeMissing script>>}}}
//tags listed in// [[FavoriteTags]]
{{{<<cloud +FavoriteTags>>}}}
{{groupbox{<<cloud +FavoriteTags>>}}}
//tags NOT listed in// [[FavoriteTags]]
{{{<<cloud -FavoriteTags>>}}}
{{groupbox{<<cloud -FavoriteTags>>}}}
//links to tiddlers tagged with 'package'//
{{{<<cloud action:goto =package>>}}}
{{groupbox{<<cloud action:goto =package>>}}}
//top 20 most referenced tiddlers//
{{{<<cloud references limit:20>>}}}
{{groupbox{<<cloud references limit:20>>}}}
//top 20 tiddlers that contain the most links//
{{{<<cloud links limit:20>>}}}
{{groupbox{<<cloud links limit:20>>}}}
<<<
!Revisions
<<<
2009.07.17 [1.7.0] added {{{-TiddlerName}}} parameter to exclude tags that are listed in the indicated tiddler
2009.02.26 [1.6.0] added {{{action:...}}} parameter to apply popup vs. goto action when clicking cloud items
2009.02.05 [1.5.0] added ability to show links or back-links (references) instead of tags and renamed macro to {{{<<cloud>>}}} to reflect more generalized usage.
2008.12.16 [1.4.2] corrected group calculation to prevent 'group=0' error
2008.12.16 [1.4.1] revised tag filtering so excluded tags don't affect calculations
2008.12.15 [1.4.0] added {{{limit:...}}} parameter to restrict the number of tags displayed to the top N most popular
2008.11.15 [1.3.0] added {{{+TiddlerName}}} parameter to include only tags that are listed in the indicated tiddler
2008.09.05 [1.2.0] added '=tagname' parameter to include only tags that are themselves tagged with the specified value (i.e., ~TagglyTagging usage)
2008.07.03 [1.1.0] added 'segments' property to macro object.  Extensive code cleanup
<<<
!Code
***/
//{{{
version.extensions.TagCloudPlugin= {major: 1, minor: 7 , revision: 0, date: new Date(2009,7,17)};
//Originally created by Clint Checketts, contributions by Jonny Leroy and Eric Shulman
//Currently maintained and enhanced by Eric Shulman
//}}}
//{{{
config.macros.cloud = {
	tagstip: "%1 tiddlers tagged with '%0'",
	refslabel: " (%0 references)",
	refstip: "%1 tiddlers have links to '%0'",
	linkslabel: " (%0 links)",
	linkstip: "'%0' has links to %1 other tiddlers",
	groups: 9,
	init: function() {
		config.macros.tagCloud=config.macros.cloud; // for backward-compatibility
		config.shadowTiddlers.TagCloud='<<cloud>>';
		config.shadowTiddlers.StyleSheetTagCloud=
			'/*{{{*/\n'
			+'.tagCloud span {line-height: 3.5em; margin:3px;}\n'
			+'.tagCloud1{font-size: 80%;}\n'
			+'.tagCloud2{font-size: 100%;}\n'
			+'.tagCloud3{font-size: 120%;}\n'
			+'.tagCloud4{font-size: 140%;}\n'
			+'.tagCloud5{font-size: 160%;}\n'
			+'.tagCloud6{font-size: 180%;}\n'
			+'.tagCloud7{font-size: 200%;}\n'
			+'.tagCloud8{font-size: 220%;}\n'
			+'.tagCloud9{font-size: 240%;}\n'
			+'/*}}}*/\n';
		setStylesheet(store.getTiddlerText('StyleSheetTagCloud'),'tagCloudsStyles');
	},
	getLinks: function(tiddler) { // get list of links to existing tiddlers and shadows
		if (!tiddler.linksUpdated) tiddler.changed();
		var list=[]; for (var i=0; i<tiddler.links.length; i++) {
			var title=tiddler.links[i];
			if (store.isShadowTiddler(title)||store.tiddlerExists(title))
				list.push(title);
		}
		return list;
	},
	handler: function(place,macroName,params) {
		// unpack params
		var inc=[]; var ex=[]; var limit=0; var action='popup';
		var links=(params[0]&&params[0].toLowerCase()=='links'); if (links) params.shift();
		var refs=(params[0]&&params[0].toLowerCase()=='references'); if (refs) params.shift();
		if (params[0]&&params[0].substr(0,7).toLowerCase()=='action:')
			action=params.shift().substr(7).toLowerCase();
		if (params[0]&&params[0].substr(0,6).toLowerCase()=='limit:')
			limit=parseInt(params.shift().substr(6));
		while (params.length) {
			if (params[0].substr(0,1)=='+') { // read taglist from tiddler
				inc=inc.concat(store.getTiddlerText(params[0].substr(1),'').readBracketedList());
			} else if (params[0].substr(0,1)=='-') { // exclude taglist from tiddler
				ex=ex.concat(store.getTiddlerText(params[0].substr(1),'').readBracketedList());
			} else if (params[0].substr(0,1)=='=') { // get tag list using tagged tags
				var tagged=store.getTaggedTiddlers(params[0].substr(1));
				for (var t=0; t<tagged.length; t++) inc.push(tagged[t].title);
			} else ex.push(params[0]); // exclude params
			params.shift();
		}
		// get all items, include/exclude specific items
		var items=[];
		var list=(links||refs)?store.getTiddlers('title','excludeLists'):store.getTags();
		for (var t=0; t<list.length; t++) {
			var title=(links||refs)?list[t].title:list[t][0];
			if (links)	var count=this.getLinks(list[t]).length;
			else if (refs)	var count=store.getReferringTiddlers(title).length;
			else 		var count=list[t][1];
			if ((!inc.length||inc.contains(title))&&(!ex.length||!ex.contains(title)))
				items.push({ title:title, count:count });
		}
		if(!items.length) return;
		// sort by decending count, limit results (optional)
		items=items.sort(function(a,b){return(a.count==b.count)?0:(a.count>b.count?-1:1);});
		while (limit && items.length>limit) items.pop();
		// find min/max and group size
		var most=items[0].count;
		var least=items[items.length-1].count;
		var groupSize=(most-least+1)/this.groups;
		// sort by title and draw the cloud of items
		items=items.sort(function(a,b){return(a.title==b.title)?0:(a.title>b.title?1:-1);});
		var cloudWrapper = createTiddlyElement(place,'div',null,'tagCloud',null);
		for (var t=0; t<items.length; t++) {
			cloudWrapper.appendChild(document.createTextNode(' '));
			var group=Math.ceil((items[t].count-least)/groupSize)||1;
			var className='tagCloudtag tagCloud'+group;
			var tip=refs?this.refstip:links?this.linkstip:this.tagstip;
			tip=tip.format([items[t].title,items[t].count]);
			if (action=='goto') { // TAG/LINK/REFERENCES GOTO
				var btn=createTiddlyLink(cloudWrapper,items[t].title,true,className);
				btn.title=tip;
				btn.style.fontWeight='normal';
			} else if (!links&&!refs) { // TAG POPUP
				var btn=createTiddlyButton(cloudWrapper,items[t].title,tip,onClickTag,className);
				btn.setAttribute('tag',items[t].title);
			} else { // LINK/REFERENCES POPUP
				var btn=createTiddlyButton(cloudWrapper,items[t].title,tip,
					function(ev) { var e=ev||window.event; var cmt=config.macros.cloud;
						var popup = Popup.create(this);
						var title = this.getAttribute('tiddler');
						var count = this.getAttribute('count');
						var refs  = this.getAttribute('refs')=='T';
						var links = this.getAttribute('links')=='T';
						var label = (refs?cmt.refslabel:cmt.linkslabel).format([count]);
						createTiddlyLink(popup,title,true);
						createTiddlyText(popup,label);
						createTiddlyElement(popup,'hr');
						if (refs) {
							popup.setAttribute('tiddler',title);
							config.commands.references.handlePopup(popup,title);
						}
						if (links) {
							var tiddler = store.fetchTiddler(title);
							var links=config.macros.cloud.getLinks(tiddler);
							for(var i=0;i<links.length;i++)
								createTiddlyLink(createTiddlyElement(popup,'li'),
									links[i],true);
						}
						Popup.show();
						e.cancelBubble=true; if(e.stopPropagation) e.stopPropagation();
						return false;
					}, className);
				btn.setAttribute('tiddler',items[t].title);
				btn.setAttribute('count',items[t].count);
				btn.setAttribute('refs',refs?'T':'F');
				btn.setAttribute('links',links?'T':'F');
				btn.title=tip;
			}
		}
	}
};
//}}}
ColorPalette
StyleSheet
SiteSubtitle
GettingStarted
SiteTitle
MainMenu
SiteIcon
DefaultTiddlers
ViewTemplate
PageTemplate
SideBarOptions
EditTemplate
SiteInfo
SideBarTabs
ToolbarCommands
The title and subtitle of your space are visible to visitors and are also displayed in your browser's tabs. Click on the SiteTitle and SiteSubtitle tiddler links below to make changes.
* [[SiteTitle]]
* [[SiteSubtitle]]
[[Mastering and Managing the FDA Maze]]
<!--{{{-->
<div macro='slideRevision'></div>
<div class='heading'>
	<span class="titleBar">
		<div class='title' macro='view title text'></div>
	</span>
	<span class='modifierIcon'
		macro='view modifier SiteIcon label:no height:48 width:48 preserveAspectRatio:yes'>
	</span>
	<div class='toolbar'
		macro='toolbar [[ToolbarCommands::RevisionToolbar]] icons:yes height:48 width:48 more:popup'>
	</div>
	<div class='tagClear'></div>
</div>
<div class='content'>
	<div class='viewer' macro='view text wikified'></div>
</div>
<div class='tagInfo'>
	<div class='tidTags' macro='tags'></div>
	<div class='tagging' macro='tagging'></div>
</div>
<!--}}}-->
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] a ''//Design History File//'' (DHF) means a compilation of records which describe the complete history of a finished device.

Two goals:
* Prove the 'recipe' is good
* Help colleagues over the life cycle (15 manyears) to find back how the recipe was created.
//(d)(2) Fluoroscopic equipment manufactured ''on or after May 19, 1995''//
* (i) Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in [[1020.32(d)(3)|CFR 1020.32 Fluoroscopic equipment (d)(3) Measuring compliance]]. Provision for manual selection of technique factors may be provided.
* (ii) Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in [[1020.32(d)(3)|CFR 1020.32 Fluoroscopic equipment (d)(3) Measuring compliance]], except as specified below (clause 1020.32(d)(2)(iii))
** (A) For equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode.
** (B) For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.
** (C) When a mode of operation has an [[optional high-level control and the control is activated|CFR 1020.32 Fluoroscopic equipment (d)(2) Optional clause for high-level control]]
/***
|''Name''|TiddlySpaceBackstage|
|''Version''|0.8.0|
|''Description''|Provides a TiddlySpace version of the backstage and a homeLink macro|
|''Status''|@@beta@@|
|''Contributors''|Jon Lister, Jon Robson, Colm Britton|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/TiddlySpaceBackstage.js|
|''Requires''|TiddlySpaceConfig ImageMacroPlugin TiddlySpaceViewTypes|
!StyleSheet
.tiddler .error.annotation .button{
	display: inline-block;
}

#backstageArea {
	z-index: 49;
	color: white;
	background-color: black;
	background: -webkit-gradient(linear,left bottom,left top,color-stop(0, #222),color-stop(0.5, #333),color-stop(1, #555));
	background: -moz-linear-gradient(center bottom,#222 0%, #333 50%, #555 100%);
	filter: progid:DXImageTransform.Microsoft.gradient(startColorstr=#ff555555, endColorstr=#ff222222);
	-ms-filter: "progid:DXImageTransform.Microsoft.gradient(startColorstr=#ff555555, endColorstr=#ff222222)";
	height: 25px;
	padding: 0;
}

#backstageButton {
	overflow: hidden;
}

#backstageButton #backstageShow,
#backstageButton #backstageHide {
	margin: 0px;
	padding: 0px;
}

#backstageButton #backstageShow:hover,
#backstageButton #backstageHide:hover {
	background: none;
	color: none;
}

#backstageButton img,
#backstageButton svg {
	width: 24px;
	height: 24px;
}

#messageArea {
	top: 50px;
}

#backstageToolbar {
	position: relative;
}

#backstageArea a {
	padding: 0px;
	margin-left: 0px;
	color: white;
	background: none;
}

#backstageArea a:hover {
	background-color: white;
}

#backstage ol,
#backstage ul {
	padding: auto;
}

#backstageButton a {
	margin: 0;
}

.backstagePanelBody ul {
	padding: 5px;
	margin: 5px;
}

#backstage #backstagePanel {
	margin-left: 5%;
	padding: 0em;
	margin-right: 5%;
}

#backstageToolbar a {
	position: relative;
}

#backstageArea a.backstageSelTab,
#backstageToolbar .backstageTask {
	line-height: 25px;
	color: #767676;
}

.backstageTask .externalImage,
.backstageTask .image {
	display: inline;
}

#backstageToolbar a span {
	z-index: 2;
}

a.backstageTask {
	display: inline;
        margin-left: 1em !important;
}

.backstagePanelBody .button {
	display: inline-block;
	margin-right: 10px;
}

.backstagePanelBody {
	margin: 0 0 0 0.6em;
	padding: 0.4em 0.5em 1px 0.5em;
}

#backstage table {
	margin: auto;
}

#backstage .wizard table {
	border: 0px;
	margin: 0;
}

#backstage div  li.listLink {
	border: 0px;
	width: 78%;
	font-size: 0.7em;
}

#backstage div li.listTitle {
	font-weight: bold;
	text-decoration: underline;
	font-size: 1em;
	background: #ccc;
	width: 100%;
}

#backstage fieldset {
	border: solid 1px [[ColorPalette::Background]];
}

#backstage .viewer table,#backstage table.twtable {
	border: 0px;
}

#backstageToolbar img {
	padding: 0;
}

#backstage .wizard,
#backstage .wizardFooter {
	background: none;
}

.viewer td, .viewer tr, .twtable td, .twtable tr {
	border: 1px solid #eee;
}

#backstage .inlineList ul li {
	background-color: [[ColorPalette::Background]];
	border: solid 1px [[ColorPalette::TertiaryMid]];
	display: block;
	float: left;
	list-style: none;
	margin-right: 1em;
	padding: 0.5em;
}

.backstageClear, .inlineList form {
	clear: both;
	display: block;
	margin-top: 3em;
}

.tiddlyspaceMenu {
	text-align: center;
}

span.chunkyButton {
	display: inline-block;
	padding: 0;
	margin: 0;
	border: solid 2px #000;
	background-color: #04b;
}

span.chunkyButton a.button, span.chunkyButton a:active.button {
	white-space: nowrap;
	font-weight: bold;
	font-size: 1.8em;
	color: #fff;
	text-align: center;
	padding: 0.5em 0.5em;
	margin: 0;
	border-style: none;
	display: block;
}

span.chunkyButton:hover {
	background-color: #014;
}

span.chunkyButton a.button:hover {
	border-style: none;
	background: none;
	color: #fff;
}

#backstage .unpluggedSpaceTab .wizard,
.unpluggedSpaceTab .wizard {
	background: white;
	border: 2px solid #CCC;
	padding: 5px;
}

.syncKey .keyItem {
	border: 1px solid black;
	display: inline-block;
	margin: 0.2em;
	padding: 0.1em 0.1em 0.1em 0.1em;
}

.keyHeading {
	font-size: 2em;
	font-weight: bold;
	margin: 0.4em 0em -0.2em;
}

.unpluggedSpaceTab .putToServer,
.unpluggedSpaceTab .notChanged {
	display: none;
}

.tiddlyspaceMenu ul {
	margin: 0;
	padding: 0;
}

.tiddlyspaceMenu ul li {
	list-style: none;
}

.unsyncedChanges .unsyncedList {
	display: block;
}

.unsyncedList {
	display: none;
}
!Code
***/
//{{{
(function ($) {
    var name = "StyleSheet" + tiddler.title;
    config.shadowTiddlers[name] = "/*{{{*/\n%0\n/*}}}*/".
        format(store.getTiddlerText(tiddler.title + "##StyleSheet")); // this accesses the StyleSheet section of the current tiddler (the plugin that contains it)
    store.addNotification(name, refreshStyles);

    if (!config.extensions.tiddlyweb.status.tiddlyspace_version) { // unplugged
        config.extensions.tiddlyweb.status.tiddlyspace_version = "<unknown>";
        config.extensions.tiddlyweb.status.server_host = {
            url:config.extensions.tiddlyweb.host }; // TiddlySpaceLinkPlugin expects this
    }
    var disabled_tasks_for_nonmembers = ["tiddlers", "plugins", "batch", "sync"];

    var tweb = config.extensions.tiddlyweb;
    var tiddlyspace = config.extensions.tiddlyspace;
    var currentSpace = tiddlyspace.currentSpace.name;
    var imageMacro = config.macros.image;

    if (config.options.chkBackstage === undefined) {
        config.options.chkBackstage = false;
    }

// Set up Backstage
    config.tasks = {};
    config.tasks.status = {
        text:"status",
        tooltip:"TiddlySpace Info",
        content:"<<tiddler Backstage##Menu>>"
    };
    config.tasks.tiddlers = {
        text:"tiddlers",
        tooltip:"tiddlers control panel",
        content:"<<tiddler Backstage##BackstageTiddlers>>"
    };
    config.tasks.plugins = {
        text:"plugins",
        tooltip:"Manage installed plugins",
        content:"<<tiddler Backstage##Plugins>>"
    };
    config.tasks.batch = {
        text:"batch",
        tooltip:"Batch manage public/private tiddlers",
        content:"<<tiddler Backstage##BatchOps>>"
    };
    config.tasks.tweaks = {
        text:"tweaks",
        tooltip:"Tweak TiddlyWiki behaviors",
        content:"<<tiddler Backstage##Tweaks>>"
    };
    config.tasks.exportTiddlers = {
        text:"import/export",
        tooltip:"Import/export tiddlers from/to a TiddlyWiki",
        content:"<<tiddler Backstage##ImportExport>>"
    };
    config.tasks.sync = {
        text:"sync",
        tooltip:"Check Sync status",
        content:"<<tiddler Backstage##SpaceUnplugged>>"
    };

    if (window.location.protocol === "file:") {
        config.unplugged = true;
    }

    config.backstageTasks = ["status", "tiddlers", "plugins",
        "batch", "tweaks", "exportTiddlers", "sync"];

    config.messages.backstage.prompt = "";
// initialize state
    var _show = backstage.show;
    backstage.show = function () {
        // selectively hide backstage tasks and tabs based on user status
        var tasks = $("#backstageToolbar .backstageTask").show();
        var bs = backstage.tiddlyspace;
        if (!config.unplugged) {
            tweb.getUserInfo(function (user) {
                if (user.anon) {
                    jQuery.each(disabled_tasks_for_nonmembers, function (i, task) {
                        var taskIndex = config.backstageTasks.indexOf(task);
                        if (taskIndex !== -1) {
                            config.backstageTasks.splice(taskIndex, 1);
                        }
                    });
                    config.messages.memberStatus = bs.locale.loggedout;
                } else {
                    config.messages.memberStatus = readOnly ?
                        bs.locale.nonmember : bs.locale.member;
                }
            });
        } else {
            config.messages.memberStatus = bs.locale.unplugged;
        }

        // display backstage
        return _show.apply(this, arguments);
    };
    if (readOnly) {
        jQuery.each(disabled_tasks_for_nonmembers, function (i, task) {
            var taskIndex = config.backstageTasks.indexOf(task);
            if (taskIndex !== -1) {
                config.backstageTasks.splice(taskIndex, 1);
            }
        });
    }

    var tasks = config.tasks;
    var commonUrl = "/bags/common/tiddlers/%0";

    backstage.tiddlyspace = {
        locale:{
            member:"You are a member of this space.",
            nonmember:"You are not a member of this space.",
            loggedout:"You are currently logged out of TiddlySpace.",
            unplugged:"You are unplugged."
        },
        showButton:function () {
            var showBtn = $("#backstageShow")[0];
            var altText = $(showBtn).text();
            $(showBtn).empty();
            imageMacro.renderImage(showBtn, "backstage.svg",
                { altImage:commonUrl.format("backstage.png"), alt:altText});
        },
        hideButton:function () {
            var hideBtn = $("#backstageHide")[0];
            var altText = $(hideBtn).text();
            $(hideBtn).empty();
            imageMacro.renderImage(hideBtn, "close.svg",
                { altImage:commonUrl.format("close.png"), alt:altText, width:24, height:24 });
        }
    };

    var _init = backstage.init;
    backstage.init = function () {
        _init.apply(this, arguments);
        var init = function (user) {
            var bs = backstage.tiddlyspace;
            bs.showButton();
            bs.hideButton();
        };
        tweb.getUserInfo(init);
    };

    var home = config.macros.homeLink = {
        locale:{
            linkText:"your home space"
        },
        handler:function (place) {
            var container = $("<span />").appendTo(place)[0];
            tweb.getUserInfo(function (user) {
                if (!user.anon && user.name !== currentSpace) {
                    createSpaceLink(container, user.name, null, home.locale.linkText);
                }
            });
        }
    };

    config.macros.exportSpace = {
        handler:function (place, macroName, params) {
            var filename = params[0] ||
                "/tiddlers.wiki?download=%0.html".format(currentSpace);
            $('<a class="button">download</a>').// XXX: i18n
                attr("href", filename).appendTo(place);
        }
    };

}(jQuery));
//}}}
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
''7.3.1 Design and development planning''

The organization shall establish documented procedures for design and development.
The organization shall plan and control the design and development of product.

During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification, validation and design transfer activities (see Note) that are appropriate at each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

Planning output shall be documented, and updated as appropriate, as the design and development
progresses (see 4.2.3).

NOTE [[Design Transfer]] activities during the design and development process ensure that design and development
outputs are verified as suitable for manufacturing before becoming final production specifications.
//(4) Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently ''circular'' image receptors//

* (i) For fluoroscopic equipment manufactured //''before June 10, 2006''//, other than radiation therapy simulation systems, the following applies:

** (A) Neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID.

** (B) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

* (ii) For fluoroscopic equipment manufactured ''//on or after June 10, 2006//'', other than radiation therapy simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one of the following requirements:

** (A) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is //''less than or equal to 34 cm''// in any direction, at least 80 percent of the area of the x-ray field overlaps the visible area of the image receptor, or

** (B) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is //''greater than 34 cm in any direction''//, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than 2 cm.
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
/***
|''Name''|ImageMacroPlugin|
|''Version''|0.9.4|
|''Description''|Allows the rendering of svg images in a TiddlyWiki|
|''Author''|Osmosoft|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''Notes''|Currently only works in modern browsers (not IE)|
|''Requires''|BinaryTiddlersPlugin|
!Usage
{{{<<image SVG>>}}} will render the text of the tiddler with title SVG as an SVG image (but not in ie where it will fail silently)
!!Parameters
width/height: specify width/height parameters
link: make the image link to a given location
tiddlyLink: link to a tiddler

!Notes
Binary tiddlers in TiddlyWeb when passed through the wikifier will be shown as images.
eg. {{{<<view text wikified>>}}} on a binary tiddler will show the image.
{{{<<view fieldname image>>}}}
will render the value of the tiddler field 'fieldname' as an image. This field can contain a tid
{{{<<image SiteIcon>>}}}
will create an image tag where the tiddler has content type beginning image and not ending +xml
will attempt to create svg object in other scenarios
{{{<<image /photos/x.jpg>>}}}
will create an image tag with src /photos/x.jpg as long as there is not a tiddler called /photos/x.jpg in 
which case it will render that tiddler as an image. Note for the case of svg files it will attempt to render as an svg if possible via the image
tag. It doesn't embed the svg in the dom for security reasons as svg code can contain javascript.
!Code
***/
//{{{
(function($) {

var macro = config.macros.image = {
	shim: "/bags/common/tiddlers/shim",
	ieVersion: config.browser.isIE ? parseInt(config.browser.ieVersion[1], 10) : false,
	svgns: "http://www.w3.org/2000/svg",
	xlinkns: "http://www.w3.org/1999/xlink", 
	svgAvailable: document.implementation.hasFeature("http://www.w3.org/TR/SVG11/feature#BasicStructure", "1.1"),
	_fixPrefix: 1,
	_external_cache: {},
	_image_tag_cache: {},
	_image_dimensions: {},
	locale: {
		badImage: "This image cannot be displayed."
	},
	handler: function(place, macroName, params, wikifier, paramString, tiddler){
		var imageSource = params[0];
		// collect named arguments
		var args = macro.getArguments(paramString, params);
		this.renderImage(place, imageSource, args);
	},
	init: function() {
		var startupImages = store.getTaggedTiddlers("systemImage");
		var place = $("<div />").attr("id", "systemImageArea").appendTo("body").hide()[0];
		for(var i = 0; i < startupImages.length; i++) {
			var image = startupImages[i];
			macro.renderImage(place, image.title, { idPrefix: "" });
		}
		var data = new Image();
		data.onload = function() {
			// note ie 8 only supports data uris up to 32k so cannot be relied on
			macro.supportsDataUris = this.width != 1 || this.height != 1 ? false : true;
			macro.supportsDataUris = macro.ieVersion && macro.ieVersion < 9 ? false : macro.supportsDataUris;
		};
		data.onerror = data.onload;
		data.src = "data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///ywAAAAAAQABAAACAUwAOw==";
	},
	refreshImage: function(src) {
		var elements = macro._image_tag_cache[src] ? macro._image_tag_cache[src] : [];
		if(macro._image_dimensions[src]) {
			macro._image_dimensions[src] = false;
		}
		for(var i = 0; i < elements.length; i++) {
			var el = $(elements[i]);
			var newSrc = "%0?nocache=%1".format(src, Math.random());
			el.attr("src", newSrc); // force reload
		}
	},
	isBinaryImageType: function(contentType) {
		return (contentType && contentType.indexOf("image") === 0 &&
			contentType.indexOf("+xml") != contentType.length - 4) ? true : false;
	},
	isImageTiddler: function(tiddler) {
		return macro.isSVGTiddler(tiddler) || macro.isBinaryImageTiddler(tiddler);
	},
	isSVGTiddler: function(tiddler) {
		var type = tiddler ? tiddler.fields['server.content-type'] : false;
		return type == "image/svg+xml";
	},
	isBinaryImageTiddler: function(tiddler) {
		return macro.isBinaryImageType(tiddler.fields['server.content-type']);
	},
	renderImage: function(place, imageSource, options) {
		var imageTiddler = store.getTiddler(imageSource);
		var container;
		var classes = ["image"];
		if(options.link) {
			classes = classes.concat(["imageLink", "externalLink"]);
			container = $("<a />").attr("href", options.link).appendTo(place)[0];
		} else if(options.tiddlyLink) {
			classes.push("imageLink");
			container = createTiddlyLink(place, options.tiddlyLink, false);
		} else {
			container = $("<span />").appendTo(place)[0];
		}
		$(container).addClass(classes.join(" "));

		options = options ? options : {};
		if(imageTiddler && macro.isBinaryImageTiddler(imageTiddler)) { // handle the case where we have an image url
			return macro._renderBinaryImageTiddler(container, imageTiddler, options);
		} else if(imageTiddler){ // handle the case where we have a tiddler
			return macro._renderSVGTiddler(container, imageTiddler, options);
		} else { // we have a string representing a url
			return macro._renderBinaryImageUrl(container, imageSource, options);
		}
	},
	_renderAlternateText: function(container, options) {
		var img;
		var src = options.src || "";
		if(options.width && options.height) {
			img = $("<img />").attr("src", src).addClass("svgImageText").attr("width", options.width).
				attr("height", options.height).appendTo(container);
		}
		var alt = options.alt;
		if(img && alt) {
			img.attr("alt", alt).attr("title", alt);
		} else if(alt) {
			$(container).addClass("svgImageText").text(alt);
		}
		macro._image_tag_cache[src] = img;
	},
	_renderSVGTiddler: function(place, tiddler, options) {
		if(!options) {
			options = {};
		}
		merge(options, { tiddler: tiddler, fix: true});

		if(macro.svgAvailable) {
			this._importSVG(place, options); // display the svg
		} else if(options.altImage) {
			var image = options.altImage;
			delete options.altImage;
			this._renderBinaryImageUrl(place, image, options);
		} else {
			this._renderAlternateText(place, options); // instead of showing the image show the alternate text.
		}
	},
	_renderBinaryImageTiddler: function(place, tiddler, options) {
		var resourceURI;
		var fields = tiddler.fields;
		if(fields["server.type"] == "tiddlyweb") { // construct an accurate url for the resource
			resourceURI = "%0/%1/tiddlers/%2".format(config.defaultCustomFields["server.host"],
				fields["server.workspace"], encodeURI(fields["server.title"]));
		} else { // guess the url for the resource
			resourceURI = tiddler.title;
		}
		var ctype = fields["server.content-type"] || tiddler.type;
		var text = tiddler.text;
		if(macro.supportsDataUris && ctype && text.indexOf("<html") == -1) {
			var uri = "data:%0;base64,%1".format(ctype, text);
			options.src = resourceURI;
			return macro._renderBinaryImageUrl(place, uri, options);
		} else if(options.src) {
			return macro._renderBinaryImageUrl(place, options.src, options);
		} else {
			return macro._renderBinaryImageUrl(place, resourceURI, options);
		}
	},
	_renderImageTag: function(container, src, width, height, options) {
		var img;
		img = $("<img />").appendTo(container);
		if(height) {
			img.attr("height", height);
		}
		if(width) {
			img.attr("width", width);
		}
		if(macro.ieVersion && macro.ieVersion < 7 && macro.shim && options.ie6png) {
			$(img).css({width: userW, height: userH,
					filter: "progid:DXImageTransform.Microsoft.AlphaImageLoader(src='%0', sizingMethod='scale')".format(src)
				}).attr("src", macro.shim);
		} else {
			img.attr("src", src);
		}
		if(!macro._image_tag_cache[options.srcUrl]) {
			macro._image_tag_cache[options.srcUrl] = [];
		}
		img = $(img).addClass(options.imageClass)[0];
		macro._image_tag_cache[options.srcUrl].push(img);
		return img;
	},
	_getDimensions: function(realDimensions, reqDimensions, preserve) {
		var w = realDimensions.width;
		var h = realDimensions.height;
		var reqh = reqDimensions.height;
		var reqw = reqDimensions.width;
		var finalw = w, finalh = h;
		var ratiow = reqw / w, ratioh = reqh / h;
		var scaledw = ratioh * w;
		var scaledh = ratiow * h;
		if(!reqw && reqh) {
			finalw = scaledw;
			finalh = reqh;
		} else if(reqw && !reqh) {
			finalw = reqw;
			finalh = scaledh;
		} else if(reqh && reqw) {
			var preserveWidth = w > h ? true : false;
			if(preserve) {
				if(preserveWidth && scaledh < reqh) {
					finalh = scaledh;
					finalw = reqw;
				} else {
					finalh = reqh;
					finalw = scaledw;
				}
			} else {
				finalw = reqw;
				finalh = reqh;
			}
		}
		return { width: parseInt(finalw, 10), height: parseInt(finalh, 10) };
	},
	_renderBinaryImageUrl: function(container, src, options) {
		var srcUrl = options.src ? options.src : src;
		srcUrl = srcUrl.indexOf("/") === -1 ? "/%0".format(srcUrl) : srcUrl; // for IE. 
		var image_dimensions = macro._image_dimensions[srcUrl];
		var image = new Image(); // due to weird scaling issues where you use just a width or just a height
		var createImageTag = function(dimensions, error) {
			if(error) {
				var altImage = options.altImage;
				if(altImage) {
					delete options.altImage;
					macro._renderBinaryImageUrl(container, altImage, options);
				} else {
					options.src = src;
					macro._renderAlternateText(container, options);
				}
			} else {
				var dim = macro._getDimensions(dimensions, { 
					width: options.width, height: options.height }, options.preserveAspectRatio);
				options.srcUrl = srcUrl;
				macro._renderImageTag(container, src, dim.width, dim.height, options);
			}
		};

		if(!image_dimensions) {
			image.onload = function() {
				var dimensions = { width: image.width, height: image.height};
				macro._image_dimensions[srcUrl] = dimensions;
				createImageTag(dimensions);
			};
			image.onerror = function() {
				createImageTag(null, true);
			};
			image.src = src;
		} else {
			createImageTag(image_dimensions);
		}
	},
	_generateIdPrefix: function(){
		return "twsvgfix_" + (this._fixPrefix++).toString() + "_";
	},
	_fixSVG: function(childNodes, idPrefix) {
		var urlPattern = /url\(\#([^\)]*)\)*/ig;
		var fixes = [
		{ attr: "id", pattern: /^(.*)$/ig },
		{ attr: "href", namespace: macro.xlinkns, pattern: /^#(.*)$/ig }
		];
		var url_fixes = ["filter", "fill", "mask", "stroke", "style"];
		for(var i = 0; i < url_fixes.length; i++) {
			fixes.push({ attr: url_fixes[i], pattern: urlPattern });
		}
		for(var t = 0; t < childNodes.length; t++) {
			var node = childNodes[t];
			for(var a = 0; a < fixes.length; a++) {
				var fix = fixes[a];
				var attr = fix.attr;
				var ns = fix.namespace || "";
				if(node.hasAttributeNS && node.hasAttributeNS(ns, attr)) {
					var v = node.getAttributeNS(ns, attr);
					fix.pattern.lastIndex = 0;
					var match = fix.pattern.exec(v);
					if(match) {
						// Make sure replacement string doesn't contain any single dollar signs
						var toReplace = match[1];
						if(toReplace.indexOf(idPrefix) !== 0 && toReplace.indexOf("twglobal_") !== 0) {
							var replacement = (idPrefix + toReplace).replace("$", "$$$$"); 
							v = v.replace(match[1], replacement);
						}
						node.setAttributeNS(ns, attr,v);
					}
				}
			}
			var children = node.childNodes;
			if(children.length > 0) {
				this._fixSVG(children, idPrefix);
			}
		}
	},
	_importSVG: function(place, options){
		options = options ? options : {};
		var svgDoc, tiddlerText = options.tiddler.text;
		if (window.DOMParser) {
			svgDoc = new DOMParser().parseFromString(tiddlerText, "application/xml").documentElement;
			var idPrefix = options.idPrefix || this._generateIdPrefix();
			this._fixSVG([svgDoc], idPrefix);
			var el = document.importNode(svgDoc, true);
			var svgHolder = document.createElementNS(macro.svgns,"svg");
			var width = options.width;
			var height = options.height;
			if(width || height) {
				if(width && height) { // set view box of containing svg element based on the svg viewbox and width and height.
					var viewBox = el.getAttribute("viewBox");
					var topLeft = "0 0";
					if(viewBox) {
						topLeft = viewBox.replace(/([0-9]*) +([0-9]*) +([0-9]*) +([0-9]*) */gi,"$1 $2");
					}
					svgHolder.setAttributeNS(macro.svgns, "viewBox", "0 0 %0 %1".format(width, height));
				} else {
					if(!width) {
						width = el.getAttribute("width");
					}
					if(!height) {
						height = el.getAttribute("height");
					}
				}
				svgHolder.setAttribute("width", width);
				svgHolder.setAttribute("height", height);

				el.setAttribute("width", "100%");
				el.setAttribute("height", "100%");
				svgHolder.setAttribute("class", "svgImage svgIcon %0".format(options.imageClass || ""));
				svgHolder.appendChild(el);
				place.appendChild(svgHolder);
			}
			else {
				var existing = el.className ? el.className.baseVal : "";
				el.setAttribute("class","svgImage %0".format(existing));
				place.appendChild(el);
			}
			// if a tiddler attribute is set this is read as a link
			$("[tiddler], [tiddlyLink]", place).attr("refresh", "link").click(function(ev) {
				var tiddler = $(ev.target).attr("tiddlyLink");
				if(tiddler) {
					story.displayTiddler(ev.target, tiddler);
				}
			});
		}
	},
	getArguments: function(paramString, params) {
		var args = paramString.parseParams("name", null, true, false, true)[0];
		var options = {};
		for(var id in args) {
			if(true) {
				var p = args[id];
				if(id == "def") {
					options[id] = p;
				} else {
					options[id] = p[0];
				}
			}
		}
		var width = isNaN(params[1]) ? false : parseInt(params[1], 10);
		var height = isNaN(params[2]) ? false : parseInt(params[2], 10);

		options.width = macro.lookupArgument(options, "width", width);
		options.height = macro.lookupArgument(options, "height", height);
		options.preserveAspectRatio = args.preserveAspectRatio && 
			args.preserveAspectRatio[0] == "yes" ? true : false;
		options.tiddlyLink = macro.lookupArgument(options, "tiddlyLink", false);
		options.link = macro.lookupArgument(options, "link", false);
		return options;
	},
	lookupArgument: function(args, id, ifEmpty) {
		return args[id] ? args[id] : ifEmpty;
	}
};

// update views
var _oldwikifiedview = config.macros.view.views.wikified;
// update wikifier to check tiddler type before rendering
merge(config.macros.view.views, {
	wikified: function(value, place, params, wikifier, paramString, tiddler) {
		if(macro.isImageTiddler(tiddler) && params[0] == "text") {
			var newplace = $("<div />").addClass("wikifiedImage").appendTo(place)[0];
			macro.renderImage(newplace, tiddler.title, { alt: macro.locale.badImage });
		} else {
			_oldwikifiedview.apply(this, arguments);
		}
	},
	image: function(value, place, params, wikifier, paramString, tiddler) {
		// a field can point to another tiddler whereas text is the current tiddler.
		var title = params[0] == "text" ? tiddler.title : value;
		var args = macro.getArguments(paramString, params);
		macro.renderImage(place, title, args);
	}
});
config.shadowTiddlers.StyleSheetImageMacro = [".wikifiedImage svg, .wikifiedImage .image { width: 80%; }",
	".svgImageText { background-color:[[ColorPalette::Error]]; color:#ddd; display: inline-block; }",
	"span.svgImageText { display: inline-block; overflow: hidden; }"
].join("");
store.addNotification("StyleSheetImageMacro", refreshStyles);

})(jQuery);
//}}}
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SecondaryMid: #3fa249
SecondaryDark: #0e2410
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TertiaryDark: #24150e
Error: #f88
ColorPaletteParameters: HSL([253|53], [0.44122348783304],[0.1|0.7855399828822682])
/*}}}*/
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] the ''//Specification//'' means any [[requirement|Requirements]] with with which a product, process, service, or other activity must conform.
//~~(Part of the [[ForEachTiddlerPlugin]])~~//

Create customizable lists, tables etc. for your selections of tiddlers. Specify the tiddlers to include and their order through a powerful language.

''Syntax:'' 
|>|{{{<<}}}''forEachTiddler'' [''in'' //tiddlyWikiPath//] [''where'' //whereCondition//] [''sortBy'' //sortExpression// [''ascending'' //or// ''descending'']] [''script'' //scriptText//] [//action// [//actionParameters//]]{{{>>}}}|
|//tiddlyWikiPath//|The filepath to the TiddlyWiki the macro should work on. When missing the current TiddlyWiki is used.|
|//whereCondition//|(quoted) JavaScript boolean expression. May refer to the build-in variables {{{tiddler}}} and {{{context}}}.|
|//sortExpression//|(quoted) JavaScript expression returning "comparable" objects (using '{{{<}}}','{{{>}}}','{{{==}}}'. May refer to the build-in variables {{{tiddler}}} and {{{context}}}.|
|//scriptText//|(quoted) JavaScript text. Typically defines JavaScript functions that are called by the various JavaScript expressions (whereClause, sortClause, action arguments,...)|
|//action//|The action that should be performed on every selected tiddler, in the given order. By default the actions [[addToList|AddToListAction]] and [[write|WriteAction]] are supported. When no action is specified [[addToList|AddToListAction]] is used.|
|//actionParameters//|(action specific) parameters the action may refer while processing the tiddlers (see action descriptions for details). <<tiddler [[JavaScript in actionParameters]]>>|
|>|~~Syntax formatting: Keywords in ''bold'', optional parts in [...]. 'or' means that exactly one of the two alternatives must exist.~~|


''Using JavaScript''

To give you a lot of flexibility the [[ForEachTiddlerMacro]] uses JavaScript in its arguments. Even if you are not that familiar with JavaScript you may find forEachTiddler useful. Just have a look at the various ready-to-use [[ForEachTiddlerExamples]] and adapt them to your needs.

''The Elements of the Macro''

The arguments of the ForEachTiddlerMacro consist of multiple parts, each of them being optional.

<<slider chkFETInClause [[inClause]] "inClause" "inClause">>
<<slider chkFETWhereClause [[whereClause]] "whereClause" "whereClause">>
<<slider chkFETSortClause [[sortClause]] "sortClause" "sortClause">>
<<slider chkFETScriptClause [[scriptClause]] "scriptClause" "scriptClause">>
<<slider chkFETActions [[Action Specification]] "Action Specification" "Action Specification">>

''Using Macros and ">" inside the forEachTiddler Macro''

You may use other macro calls into the expression, especially in the actionParameters. To avoid that the {{{>>}}} of such a macro call is misinterpreted as the end of the {{{<<forEachTiddler...>>}}} macro you must escape the {{{>>}}} of the inner macro with {{{$))}}} E.g. if you want to use {{{<<tiddler ...>>}}} inside the {{{forEachTiddler}}} macro you have to write {{{<<tiddler ...$))}}}.

In addition it is necessary to escape single {{{>}}} with the text {{{$)}}}.

''Using {{{<<tiddler ... with: ...>>}}} to re-use ForEachTiddler definitions''

Sometimes you may want to use a certain ForEachTiddler definition in slight variations. E.g. you may want to list either the tiddlers tagged with "ToDo" and in the other case with "Done". To do so you may use "Tiddler parameters". Here an example:

Replace the variable part of the ForEachTiddler definition with $1 ($2,... $9 are supported). E.g. you may create the tiddler "ListTaggedTiddlers" like this
{{{
<<forEachTiddler 
 where 
 'tiddler.tags.contains("$1")'
>>
}}}

Now you can use the ListTaggedTiddlers for various specific tags, using the {{{<<tiddler ...>>}}} macro:
{{{
<<tiddler ListTaggedTiddlers with: "systemConfig">>
}}}
{{{
<<tiddler ListTaggedTiddlers with: "Plugin">>
}}}


See also [[ForEachTiddlerExamples]].
The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.

//(a) Primary protective barrier//
[[(a)(1) Limitation of useful beam|CFR 1020.32 Fluoroscopic equipment (a)(1) Limitation of useful beam]]
[[(a)(2) Measuring compliance|CFR 1020.32 Fluoroscopic equipment (a)(2) Measuring compliance]]

//(b) Field limitation//
* [[(b)(1) Angulation|CFR 1020.32 Fluoroscopic equipment (b)(1) Angulation]]
* [[(b)(2) Further means for limitation|CFR 1020.32 Fluoroscopic equipment (b)(2) Further means for limitation]]
* [[(b)(3) Non-image-intensified fluoroscopy|CFR 1020.32 Fluoroscopic equipment (b)(3) Non-image-intensified fluoroscopy]]
* [[(b)(4) Circular image receptors|CFR 1020.32 Fluoroscopic equipment (b)(4) Circular image receptors]]
* [[(b)(5) Rectangular image receptors|CFR 1020.32 Fluoroscopic equipment (b)(5) Rectangular image receptors]]
* [[(b)(6) Override capability|CFR 1020.32 Fluoroscopic equipment (b)(6) Override capability]]

//(c) Activation of tube//
* [[(c) Activation of tube|CFR 1020.32 Fluoroscopic equipment (c) Activation of tube]]

//(d) Air kerma rates//
For fluoroscopic equipment, the following requirements apply:
* [[(d)(1) equipment manufactured before May 19, 1995|CFR 1020.32 Fluoroscopic equipment (d)(1) equipment manufactured before May 19, 1995]]
* [[(d)(2) equipment manufactured on or after May 19, 1995|CFR 1020.32 Fluoroscopic equipment (d)(2) equipment manufactured on or after May 19, 1995]]
* [[(d)(3) Measuring compliance|CFR 1020.32 Fluoroscopic equipment (d)(3) Measuring compliance]]
* [[(d)(4) Exemptions|CFR 1020.32 Fluoroscopic equipment (d)(4) Exemptions]]

(e) [Reserved]

//(f) Indication of potential and current//
* [[(f) Indication of potential and current|CFR 1020.32 Fluoroscopic equipment (f) Indication of potential and current]]

//(g) Source-skin distance//
* [[(g) Source-skin distance|CFR 1020.32 Fluoroscopic equipment (g) Source-skin distance]]

//(h) Fluoroscopic irradiation time, display, and signal//
* [[(h)(1) before June 10 2006|CFR 1020.32 Fluoroscopic equipment (h)(1) Fluoroscopic irradiation time, display, and signal before June 10 2006]]
* [[(h)(2) after June 10 2006|CFR 1020.32 Fluoroscopic equipment (h)(2) Fluoroscopic irradiation time, display, and signal after June 10 2006]]

(i) Mobile and portable fluoroscopes. In addition to the other requirements of this section, mobile and portable fluoroscopes shall provide an image receptor incorporating more than a simple fluorescent screen.

//(j) Display of last-image-hold (LIH)//
* [[(j) Display of last-image-hold (LIH)|CFR 1020.32 Fluoroscopic equipment (j) Display of last-image-hold (LIH)]]

//(k) Displays of values of AKR and cumulative air kerma//
* [[(k) Displays of values of AKR and cumulative air kerma|CFR 1020.32 Fluoroscopic equipment (k) Displays of values of AKR and cumulative air kerma]]
The ''Design Verification Checklist'' can ensure that each device [[Design Output]] or [[Specifications]] meets the [[Design Input]] or [[Requirements]]
The Establishment Inspection Report (EIR) is the report completed by the FDA investigatprs after an inspection os completed an forwarded to their district office. The report is lengthy an provides details of the form, its management, products, the inspection, the investigators findings and concerns related to the 'objectionable conditions or practices that are identified in [[FDA 483]] as 'observations'.

During delivery of the [[FDA 483]] form whenever the inspector makes a 483 observation that you believe may not be correct, you should note your position politely but firmly and request it be noted in the EIR.
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//beta testing//'' is defined to refer to testing of a finished medical device at a user's facility.
Welcome to [[Dirk-Jan Swagerman's|http://nl.linkedin.com/in/djswagerman]] [[tiddlyspace|www.tiddlyspace.com]]. I host my own tiddlyspace for notekeeping and bookmarking on different subjects. The site is primairly aimed for my own use. For public articles read my [[blog|http://blog.dirkjanswagerman.nl]].

You can explore the different subjects in the menu bar on top:

* [[Mbi|http://mbi.dirkjanswagerman.nl]], study notes for my Master of Business Innovation study at ~Tias-Nimbas
* [[Sales|http://sales.dirkjanswagerman.nl]], summary of 3 books on sales, negotiation and influence.
* [[Games|http://games.dirkjanswagerman.nl]], started reading the book [[Gamestorming]]@games but extended with other games i stumbled upon
* [[Software|http://software.dirkjanswagerman.nl]], bookmarks on software
* [[Microscopy|http://microscopy.dirkjanswagerman.nl]], lectures and bookmarks about microscopy.
* [[Management|http://management.dirkjanswagerman.nl]], softskills and management bookmarks
* [[Nanotechnology|http://nanotechnology.dirkjanswagerman.nl]], bookmarks on nano tech in general
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Design Teams//'' are teams of appropriate individuals, departments and activities representing management, sales and marketing, design and development, manufacturing, quality assurance and service and support who are charged with managing and controlling a device design and development.
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] the ''//Master Verification//'' or Validation Plan is a document that identifies all responsibilities, expectations, systems and subsystems involved with a specific verification or validation activitity and the qualification approaches that ensure verification or total system validation.
''6.4 Work environment''

The organization shall determine and manage the work environment needed to achieve conformity to product
requirements.

The following requirements shall apply.
a) The organization shall establish documented requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could adversely affect the quality of the product (see 7.5.1.2.1).
b) If work environment conditions can have an adverse effect on product quality, the organization shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions (see 7.5.1.2.1).
c) The organization shall ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained or supervised by a trained person [see 6.2.2 b)].
d) If appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel (see 7.5.3.1).
<<YouTubeFragment iB8JDuHTdIk>>
''4.2.3 Control of documents''

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed
a) to review and approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they
are retained for any purpose.

The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions.

The organization shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.4), or as specified by relevant regulatory requirements.
(function() {
var getCSRFToken = function(window) {
	// XXX: should not use RegEx - cf.
	// http://www.quirksmode.org/js/cookies.html
	// https://github.com/TiddlySpace/tiddlyspace/commit/5f4adbe009ed4bda3ce39058a3fb07de1420358d
	var regex = /^(?:.*; )?csrf_token=([^(;|$)]*)(?:;|$)/;
	var match = regex.exec(document.cookie);
	var csrf_token = null;
	if (match && (match.length === 2)) {
		csrf_token = match[1];
	}

	return csrf_token;
};

if (typeof config !== 'undefined' && config.extensions &&
		config.extensions.tiddlyspace &&
		config.extensions.tiddlyspace.getCSRFToken === null) {
	config.extensions.tiddlyspace.getCSRFToken = getCSRFToken;
} else {
	window.getCSRFToken = getCSRFToken;
}
})(window);
Welcome to your brand new [[TiddlySpace]]@glossary.

To get started with this blank [[TiddlySpace]]@glossary, you'll need to modify the following [[tiddlers|Tiddler]]@glossary:
* If you don't like the color scheme click <<RandomColorPaletteButton>> to generate a new random color scheme.
* Upload a [[SiteIcon|SiteIcon tiddler]]@glossary. [[Your SiteIcon|SiteIcon]] gives your space an identity to make it recognisable to others. A good site icon will be square and at least 48*48 pixels size.
<<binaryUploadPublic title:SiteIcon>>
* [[SiteTitle]] & [[SiteSubtitle]]: The title and subtitle of the site, as shown above (after saving, they will also appear in the browser title bar)
* [[MainMenu]]: The menu (usually on the left)
* [[DefaultTiddlers]]: Contains the names of the tiddlers that you want to appear when the ~TiddlySpace is opened
* Many features of ~TiddlySpace are accessed via the backstage bar located at the top of the page. You can toggle it on or off using the button in the top right corner of the screen.
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] a ''//Design Review//'' menans a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the ecapability of the design to meet these requirements and to identify problems.
$\tan (x) / y $
<<PlotFunction "y = tan(x) / sin(x)" "600" "200">>
The purpose of this Quality Manual is to demonstrate external regulations and requirements are fulfilled. 
<<view title link>>
//<<view ##Description text>>//
Code:
{{annotation{
http://htmljs.tiddlyspace.com/ <<view title text>>
}}}
Type of Records

A record is evidence of performing a process or activity or an output of a process.

According to the standard, records will serve two main purposes:
Verification of execution. Records are used to prove conformity to requirements or specifications. A procedure, specification, or other documented requirement demands the execution of a process or activity. With records it is possible to verify that it was done according to the specification: time, sequence, responsibility, and activities.
Evaluation of effectiveness. With the records one can review the effectiveness of an activity and appraise the results against criteria.
''6.2.1 General''

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Verification//'' means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
''7.1 Planning of product realization''

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see [[4.1 General Requirements|ISO13485 - 4.1 General Requirements]]).

In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization’s method of operations.
The organization shall establish documented requirements for risk management throughout product
realization. Records arising from risk management shall be maintained (see [[4.2.4 Control of records|ISO13485 - 4.2.4 Control of records]]).

NOTE 1 A document specifying the processes of the quality management system (including the product realization
processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization
processes.
NOTE 3 See ISO 14971 for guidance related to risk management.
''5.1 Management commitment''

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources

NOTE For the purposes of this International Standard, statutory requirements are limited to the safety and performance of the medical device only.
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Fault Tree Analysis//'' (FTA) is a systematic inductive technique that diagrams information on a system and can be used to assess a systsmes known, probable or potential failures.

<<image /static/files/FDA/Fault%20Tree%20Analysis%20Example.jpg width:400>>

See also: http://en.wikipedia.org/wiki/Fault_tree_analysis
<<deliciousImport djswagerman>>
<<list filter [tag[bookmark]][sort[-modified]]>>
[[ISO 9000]] Quality management systems — Fundamentals and vocabulary
''5.4.1 Quality objectives''

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the [[Quality Policy]]
//(1) Angulation//
For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with paragraphs [[(b)(4)|CFR 1020.32 Fluoroscopic equipment (b)(4) Circular image receptors]] (for circular image receptors) and [[(b)(5)|CFR 1020.32 Fluoroscopic equipment (b)(5) Rectangular image receptors]] (for rectangular image receptors) of this section shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
ISO is a International Standard published by the International Organization for
Standardization
 A ''Bottum-up inspection'' was the FDA standard inspection prior to 1998.
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		L 346.5 234.00005 L 348.75 231.75003 Z M 301.5 273.9719 C 301.5 273.9719 309.59888 277.99927 317.70013 273.97183 
		C 325.80066 269.94437 341.99997 276.65686 341.99997 276.65686 L 341.99997 273.97195 
		C 341.99997 273.97195 325.80014 267.2594 317.70013 271.28687 C 309.6 275.31451 301.5 271.28683 301.5 271.28683 Z" 
		fill="#101010" class="glyph"/>
	</g>
</g>
</svg>
/***
|''Name:''|DataTiddlerPlugin|
|''Version:''|1.0.7 (2012-04-19)|
|''Summary:''|Enhance your tiddlers with structured data (such as strings, booleans, numbers, or even arrays and compound objects) that can be easily accessed and modified through named fields (in JavaScript code).|
|''Source:''|http://tiddlywiki.abego-software.de/#DataTiddlerPlugin|
|''Twitter:''|[[@abego|https://twitter.com/#!/abego]]|
|''Author:''|UdoBorkowski (ub [at] abego-software [dot] de)|
|''License:''|[[BSD open source license|http://www.abego-software.de/legal/apl-v10.html]]|
!Description
Enhance your tiddlers with structured data (such as strings, booleans, numbers, or even arrays and compound objects) that can be easily accessed and modified through named fields (in JavaScript code).

Such tiddler data can be used in various applications. E.g. you may create tables that collect data from various tiddlers. 

''//Example: "Table with all December Expenses"//''
{{{
<<forEachTiddler
    where
        'tiddler.tags.contains("expense") && tiddler.data("month") == "Dec"'
    write
        '"|[["+tiddler.title+"]]|"+tiddler.data("descr")+"| "+tiddler.data("amount")+"|\n"'
>>
}}}
//(This assumes that expenses are stored in tiddlers tagged with "expense".)//
<<forEachTiddler
    where
        'tiddler.tags.contains("expense") && tiddler.data("month") == "Dec"'
    write
        '"|[["+tiddler.title+"]]|"+tiddler.data("descr")+"| "+tiddler.data("amount")+"|\n"'
>>
For other examples see DataTiddlerExamples.




''Access and Modify Tiddler Data''

You can "attach" data to every tiddler by assigning a JavaScript value (such as a string, boolean, number, or even arrays and compound objects) to named fields. 

These values can be accessed and modified through the following Tiddler methods:
|!Method|!Example|!Description|
|{{{data(field)}}}|{{{t.data("age")}}}|Returns the value of the given data field of the tiddler. When no such field is defined or its value is undefined {{{undefined}}} is returned.|
|{{{data(field,defaultValue)}}}|{{{t.data("isVIP",false)}}}|Returns the value of the given data field of the tiddler. When no such field is defined or its value is undefined the defaultValue is returned.|
|{{{data()}}}|{{{t.data()}}}|Returns the data object of the tiddler, with a property for every field. The properties of the returned data object may only be read and not be modified. To modify the data use DataTiddler.setData(...) or the corresponding Tiddler method.|
|{{{setData(field,value)}}}|{{{t.setData("age",42)}}}|Sets the value of the given data field of the tiddler to the value. When the value is {{{undefined}}} the field is removed.|
|{{{setData(field,value,defaultValue)}}}|{{{t.setData("isVIP",flag,false)}}}|Sets the value of the given data field of the tiddler to the value. When the value is equal to the defaultValue no value is set (and the field is removed).|

Alternatively you may use the following functions to access and modify the data. In this case the tiddler argument is either a tiddler or the name of a tiddler.
|!Method|!Description|
|{{{DataTiddler.getData(tiddler,field)}}}|Returns the value of the given data field of the tiddler. When no such field is defined or its value is undefined {{{undefined}}} is returned.|
|{{{DataTiddler.getData(tiddler,field,defaultValue)}}}|Returns the value of the given data field of the tiddler. When no such field is defined or its value is undefined the defaultValue is returned.|
|{{{DataTiddler.getDataObject(tiddler)}}}|Returns the data object of the tiddler, with a property for every field. The properties of the returned data object may only be read and not be modified. To modify the data use DataTiddler.setData(...) or the corresponding Tiddler method.|
|{{{DataTiddler.setData(tiddler,field,value)}}}|Sets the value of the given data field of the tiddler to the value. When the value is {{{undefined}}} the field is removed.|
|{{{DataTiddler.setData(tiddler,field,value,defaultValue)}}}|Sets the value of the given data field of the tiddler to the value. When the value is equal to the defaultValue no value is set (and the field is removed).|
//(For details on the various functions see the detailed comments in the source code.)//


''Data Representation in a Tiddler''

The data of a tiddler is stored as plain text in the tiddler's content/text, inside a "data" section that is framed by a {{{<data>...</data>}}} block. Inside the data section the information is stored in the [[JSON format|http://www.crockford.com/JSON/index.html]]. 

//''Data Section Example:''//
{{{
<data>{"isVIP":true,"user":"John Brown","age":34}</data>
}}}

The data section is not displayed when viewing the tiddler (see also "The showData Macro").

Beside the data section a tiddler may have all kind of other content.

Typically you will not access the data section text directly but use the methods given above. Nevertheless you may retrieve the text of the data section's content through the {{{DataTiddler.getDataText(tiddler)}}} function.


''Saving Changes''

The "setData" methods respect the "ForceMinorUpdate" and "AutoSave" configuration values. I.e. when "ForceMinorUpdate" is true changing a value using setData will not affect the "modifier" and "modified" attributes. With "AutoSave" set to true every setData will directly save the changes after a setData.


''Notifications''

No notifications are sent when a tiddler's data value is changed through the "setData" methods. 

''Escape Data Section''
In case that you want to use the text {{{<data>}}} or {{{</data>}}} in a tiddler text you must prefix the text with a tilde ('~'). Otherwise it may be wrongly considered as the data section. The tiddler text {{{~<data>}}} is displayed as {{{<data>}}}.


''The showData Macro''

By default the data of a tiddler (that is stored in the {{{<data>...</data>}}} section of the tiddler) is not displayed. If you want to display this data you may used the {{{<<showData ...>>}}} macro:

''Syntax:'' 
|>|{{{<<}}}''showData '' [''JSON''] [//tiddlerName//] {{{>>}}}|
|''JSON''|By default the data is rendered as a table with a "Name" and "Value" column. When defining ''JSON'' the data is rendered in JSON format|
|//tiddlerName//|Defines the tiddler holding the data to be displayed. When no tiddler is given the tiddler containing the showData macro is used. When the tiddler name contains spaces you must quote the name (or use the {{{[[...]]}}} syntax.)|
|>|~~Syntax formatting: Keywords in ''bold'', optional parts in [...]. 'or' means that exactly one of the two alternatives must exist.~~|
!Source Code
***/
/***
This plugin's source code is compressed (and hidden). 
Use this [[link|http://tiddlywiki.abego-software.de/archive/DataTiddlerPlugin/1.0.7/DataTiddlerPlugin-1.0.7-src.js]] to get the readable source code.
***/
///%
if(!version.extensions.DataTiddlerPlugin){version.extensions.DataTiddlerPlugin={major:1,minor:0,revision:7,date:new Date(2012,3,19),type:"plugin",source:"http://tiddlywiki.abego-software.de/#DataTiddlerPlugin"};if(!window.story){window.story=window}if(!TiddlyWiki.prototype.getTiddler){TiddlyWiki.prototype.getTiddler=function(b){var a=this.tiddlers[b];return(a!==undefined&&a instanceof Tiddler)?a:null}}function DataTiddler(){}DataTiddler={stringify:null,parse:null};window.DataTiddler=DataTiddler;DataTiddler.getData=function(c,d,a){var b=(typeof c=="string")?store.getTiddler(c):c;if(!(b instanceof Tiddler)){throw"Tiddler expected. Got "+c}return DataTiddler.getTiddlerDataValue(b,d,a)};DataTiddler.setData=function(c,e,d,a){var b=(typeof c=="string")?store.getTiddler(c):c;if(!(b instanceof Tiddler)){throw"Tiddler expected. Got "+c+"("+b+")"}DataTiddler.setTiddlerDataValue(b,e,d,a)};DataTiddler.getDataObject=function(b){var a=(typeof b=="string")?store.getTiddler(b):b;if(!(a instanceof Tiddler)){throw"Tiddler expected. Got "+b}return DataTiddler.getTiddlerDataObject(a)};DataTiddler.getDataText=function(b){var a=(typeof b=="string")?store.getTiddler(b):b;if(!(a instanceof Tiddler)){throw"Tiddler expected. Got "+b}return DataTiddler.readDataSectionText(a)};DataTiddler.extendJSONError=function(a){if(a.name=="JSONError"){a.toString=function(){return a.name+": "+a.message+" ("+a.text+")"}}return a};DataTiddler.getTiddlerDataObject=function(a){if(a.dataObject===undefined){var b=DataTiddler.readData(a);a.dataObject=(b)?b:{}}return a.dataObject};DataTiddler.getTiddlerDataValue=function(b,d,a){var c=DataTiddler.getTiddlerDataObject(b)[d];return(c===undefined)?a:c};DataTiddler.setTiddlerDataValue=function(c,f,e,a){var d=DataTiddler.getTiddlerDataObject(c);var b=d[f];if(e==a){if(b!==undefined){delete d[f];DataTiddler.save(c)}return}d[f]=e;DataTiddler.save(c)};DataTiddler.readDataSectionText=function(a){var b=DataTiddler.getDataTiddlerMatches(a);if(b===null||!b[2]){return null}return b[2]};DataTiddler.readData=function(b){var c=DataTiddler.readDataSectionText(b);try{return c?DataTiddler.parse(c):null}catch(a){throw DataTiddler.extendJSONError(a)}};DataTiddler.getDataTextOfTiddler=function(a){var b=DataTiddler.getTiddlerDataObject(a);return DataTiddler.stringify(b)};DataTiddler.indexOfNonEscapedText=function(c,a,d){var b=c.indexOf(a,d);while((b>0)&&(c[b-1]=="~")){b=c.indexOf(a,b+1)}return b};DataTiddler.getDataSectionInfo=function(e){var a="<data>{";var f="}</data>";var d=DataTiddler.indexOfNonEscapedText(e,a,0);if(d<0){return null}var c=e.indexOf(f,d);if(c<0){return null}var b;while((b=e.indexOf(f,c+1))>=0){c=b}return{prefixEnd:d,dataStart:d+(a.length)-1,dataEnd:c,suffixStart:c+(f.length)}};DataTiddler.getDataTiddlerMatches=function(a){var f=a.text;var e=DataTiddler.getDataSectionInfo(f);if(!e){return null}var c=f.substr(0,e.prefixEnd);var b=f.substr(e.dataStart,e.dataEnd-e.dataStart+1);var d=f.substr(e.suffixStart);return[f,c,b,d]};DataTiddler.save=function(a){var e=DataTiddler.getDataTiddlerMatches(a);var d;var f;if(e===null){d=a.text;f=""}else{d=e[1];f=e[3]}var b=DataTiddler.getDataTextOfTiddler(a);var c=(b!==null)?d+"<data>"+b+"</data>"+f:d+f;if(c!=a.text){a.isDataTiddlerChange=true;a.set(a.title,c,config.options.txtUserName,config.options.chkForceMinorUpdate?undefined:new Date(),a.tags);delete a.isDataTiddlerChange;store.dirty=true;if(config.options.chkAutoSave){saveChanges()}}};DataTiddler.MyTiddlerChangedFunction=function(){if(this.dataObject&&!this.isDataTiddlerChange){delete this.dataObject}DataTiddler.originalTiddlerChangedFunction.apply(this,arguments)};config.formatters.push({name:"data-escape",match:"~<\\/?data>",handler:function(a){a.outputText(a.output,a.matchStart+1,a.nextMatch)}});config.formatters.push({name:"data",match:"<data>",handler:function(a){var b=DataTiddler.getDataSectionInfo(a.source);if(b&&b.prefixEnd==a.matchStart){a.nextMatch=b.suffixStart}else{a.outputText(a.output,a.matchStart,a.nextMatch)}}});DataTiddler.originalTiddlerChangedFunction=Tiddler.prototype.changed;Tiddler.prototype.changed=DataTiddler.MyTiddlerChangedFunction;Tiddler.prototype.data=function(b,a){return(b)?DataTiddler.getTiddlerDataValue(this,b,a):DataTiddler.getTiddlerDataObject(this)};Tiddler.prototype.setData=function(c,b,a){DataTiddler.setTiddlerDataValue(this,c,b,a)};config.macros.showData={label:"showData",prompt:"Display the values stored in the data section of the tiddler"};config.macros.showData.handler=function(a,g,h){var c=0;var d=false;if((c<h.length)&&h[c]=="JSON"){c++;d=true}var b=story.findContainingTiddler(a).getAttribute("tiddler");if(c<h.length){b=h[c];c++}try{if(d){this.renderDataInJSONFormat(a,b)}else{this.renderDataAsTable(a,b)}}catch(f){this.createErrorElement(a,f)}};config.macros.showData.renderDataInJSONFormat=function(a,b){var c=DataTiddler.getDataText(b);if(c){createTiddlyElement(a,"pre",null,null,c)}};config.macros.showData.renderDataAsTable=function(a,b){var f="|!Name|!Value|\n";var e=DataTiddler.getDataObject(b);if(e){for(var c in e){var d=e[c];f+="|"+c+"|"+DataTiddler.stringify(d)+"|\n"}}wikify(f,a)};config.macros.showData.createErrorElement=function(a,b){var c=(b.description)?b.description:b.toString();return createTiddlyElement(a,"span",null,"showDataError","<<showData ...>>: "+c)};setStylesheet(".showDataError{color: #ffffff;background-color: #880000;}","showData")}var JSON={copyright:"(c)2005 JSON.org",license:"http://www.crockford.com/JSON/license.html",stringify:function(c){var b=[];function f(a){b[b.length]=a}function d(a){var j,h=undefined,e,g;switch(typeof a){case"object":if(a){if(a instanceof Array){f("[");e=b.length;for(h=0;h<a.length;h+=1){g=a[h];if(typeof g!="undefined"&&typeof g!="function"){if(e<b.length){f(",")}d(g)}}f("]");return}else{if(typeof a.toString!="undefined"){f("{");e=b.length;for(h in a){g=a[h];if(a.hasOwnProperty(h)&&typeof g!="undefined"&&typeof g!="function"){if(e<b.length){f(",")}d(h);f(":");d(g)}}return f("}")}}}f("null");return;case"number":f(isFinite(a)?+a:"null");return;case"string":e=a.length;f('"');for(h=0;h<e;h+=1){j=a.charAt(h);if(j>=" "){if(j=="\\"||j=='"'){f("\\")}f(j)}else{switch(j){case"\b":f("\\b");break;case"\f":f("\\f");break;case"\n":f("\\n");break;case"\r":f("\\r");break;case"\t":f("\\t");break;default:j=j.charCodeAt();f("\\u00"+Math.floor(j/16).toString(16)+(j%16).toString(16))}}}f('"');return;case"boolean":f(String(a));return;default:f("null");return}}d(c);return b.join("")},parse:function(text){var p=/^\s*(([,:{}\[\]])|"(\\.|[^\x00-\x1f"\\])*"|-?\d+(\.\d*)?([eE][+-]?\d+)?|true|false|null)\s*/,token=undefined,operator=undefined;function error(m,t){throw {name:"JSONError",message:m,text:t||operator||token}}function next(b){if(b&&b!=operator){error("Expected '"+b+"'")}if(text){var t=p.exec(text);if(t){if(t[2]){token=null;operator=t[2]}else{operator=null;try{token=eval(t[1])}catch(e){error("Bad token",t[1])}}text=text.substring(t[0].length)}else{error("Unrecognized token",text)}}else{token=operator=undefined}}function val(){var k,o;switch(operator){case"{":next("{");o={};if(operator!="}"){for(;;){if(operator||typeof token!="string"){error("Missing key")}k=token;next();next(":");o[k]=val();if(operator!=","){break}next(",")}}next("}");return o;case"[":next("[");o=[];if(operator!="]"){for(;;){o.push(val());if(operator!=","){break}next(",")}}next("]");return o;default:if(operator!==null){error("Missing value")}k=token;next();return k}}next();return val()}};DataTiddler.format="JSON";DataTiddler.stringify=JSON.stringify;DataTiddler.parse=JSON.parse;
//%/
//(3) Measuring compliance//
Compliance with paragraph (d) of this section shall be determined as follows:
* (i) If the source is below the x-ray table, the AKR shall be measured at 1 cm above the tabletop or cradle.
* (ii) If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.
* (iii) In a C-arm type of fluoroscope, the AKR shall be measured at 30 cm from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 cm from the input surface of the fluoroscopic imaging assembly.
* (iv) In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.
* (v) In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 cm to the centerline of the x-ray table.
The organization shall establish documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination.

This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

The organization shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be controlled and recorded (see 4.2.4).
In FDA [[Design Outputs|CFR 21-820.30d - Design Output]] the  Detailed Design Documents should include the following:
* Schematics
* Device components
* Subassemblies
/***
<<checkForDataTiddlerPlugin>>
|''Name:''|FormTiddlerPlugin|
|''Version:''|1.0.7 (2012-04-19)|
|''Summary:''|Use form-based tiddlers to enter your tiddler data using text fields, listboxes, checkboxes etc. (All standard HTML Form input elements supported).|
|''Documentation:''|[[Introduction|FormTiddler Introduction]], [[Examples|FormTiddler Examples]]|
|''Source:''|http://tiddlywiki.abego-software.de/#FormTiddlerPlugin|
|''Twitter:''|[[@abego|https://twitter.com/#!/abego]]|
|''Author:''|UdoBorkowski (ub [at] abego-software [dot] de)|
|''License:''|[[BSD open source license|http://www.abego-software.de/legal/apl-v10.html]]|
|''Requires:''|DataTiddlerPlugin|
!Description
Use form-based tiddlers to enter your tiddler data using text fields, listboxes, checkboxes etc. (All standard HTML Form input elements supported).

''Syntax:'' 
|>|{{{<<}}}''formTiddler'' //tiddlerName//{{{>>}}}|
|//tiddlerName//|The name of the FormTemplate tiddler to be used to edit the data of the tiddler containing the macro.|

|>|{{{<<}}}''newTiddlerWithForm'' //formTemplateName// //buttonLabel// [//titleExpression// [''askUser'']] {{{>>}}}|
|//formTemplateName//|The name of the tiddler that defines the form the new tiddler should use.|
|//buttonLabel//|The label of the button|
|//titleExpression//|A (quoted) JavaScript String expression that defines the title (/name) of the new tiddler.|
|''askUser''|Typically the user is not asked for the title when a title is specified (and not yet used). When ''askUser'' is given the user will be asked in any case. This may be used when the calculated title is just a suggestion that must be confirmed by the user|
|>|~~Syntax formatting: Keywords in ''bold'', optional parts in [...]. 'or' means that exactly one of the two alternatives must exist.~~|

For details and how to use the macros see the [[introduction|FormTiddler Introduction]] and the [[examples|FormTiddler Examples]].

!Source Code
***/
/***
This plugin's source code is compressed (and hidden). 
Use this [[link|http://tiddlywiki.abego-software.de/archive/FormTiddlerPlugin/1.0.7/FormTiddlerPlugin-1.0.7-src.js]] to get the readable source code.
***/
///%
if(!window.abego){window.abego={}}abego.getOptionsValue=function(c,b){var a=c.options[b].value;if(!a&&c.options[b].text){a=c.options[b].text}return a};version.extensions.FormTiddlerPlugin={major:1,minor:0,revision:7,date:new Date(2012,3,19),type:"plugin",source:"http://tiddlywiki.abego-software.de/#FormTiddlerPlugin"};if(!window.story){window.story=window}if(!TiddlyWiki.prototype.getTiddler){TiddlyWiki.prototype.getTiddler=function(a){return t=this.tiddlers[a];return(t!=undefined&&t instanceof Tiddler)?t:null}}config.macros.formTiddler={label:"formTiddler",prompt:"Edit tiddler data using forms",setter:{button:function(b,a){},checkbox:function(b,a){b.checked=a},file:function(b,a){try{b.value=a}catch(b){}},hidden:function(b,a){b.value=a},password:function(b,a){b.value=a},radio:function(b,a){b.checked=(b.value==a)},reset:function(b,a){},"select-one":function(b,a){config.macros.formTiddler.setSelectOneValue(b,a)},"select-multiple":function(b,a){config.macros.formTiddler.setSelectMultipleValue(b,a)},submit:function(b,a){},text:function(b,a){b.value=a},textarea:function(b,a){b.value=a}},getter:{button:function(b,a){return undefined},checkbox:function(b,a){return b.checked},file:function(b,a){return b.value},hidden:function(b,a){return b.value},password:function(b,a){return b.value},radio:function(b,a){return b.checked?b.value:undefined},reset:function(b,a){return undefined},"select-one":function(b,a){return config.macros.formTiddler.getSelectOneValue(b)},"select-multiple":function(b,a){return config.macros.formTiddler.getSelectMultipleValue(b)},submit:function(b,a){return undefined},text:function(b,a){return b.value},textarea:function(b,a){return b.value}}};config.macros.formTiddler.handler=function(g,c,f,h,d,n){if(!config.macros.formTiddler.checkForExtensions(g,c)){return}var j=0;var l=undefined;if(j<f.length){l=f[j];j++}if(!l){config.macros.formTiddler.createErrorElement(g,"No form template specified in <<"+c+">>.");return}var a=store.getTiddler(l);if(!a){config.macros.formTiddler.createErrorElement(g,"Form template '"+l+"' not found.");return}var m=a.text;if(!m){return}var b=config.macros.formTiddler.getContainingTiddlerName(g);var o="form"+l+"__"+b;var k=document.createElement("form");k.setAttribute("name",o);g.appendChild(k);wikify(m,k);config.macros.formTiddler.initValuesAndHandlersInFormElements(o,DataTiddler.getDataObject(b))};config.macros.formTiddler.initValuesAndHandlersInFormElements=function(l,f){var b=config.macros.formTiddler.findForm(l);if(!b){return}try{var a=b.elements;for(var g=0;g<a.length;g++){var j=a[g];var d=config.macros.formTiddler.setter[j.type];if(d){var k=f[j.name];if(k!=null){d(j,k)}j.onchange=onFormTiddlerChange}else{config.macros.formTiddler.displayFormTiddlerError("No setter defined for INPUT element of type '"+j.type+"'. (Element '"+j.name+"' in form '"+l+"')")}}}catch(h){config.macros.formTiddler.displayFormTiddlerError("Error when updating elements with new formData. "+h)}};config.macros.formTiddler.findForm=function(c){var a=window.document.forms;for(var b=0;b<a.length;b++){var d=a[b];if(d.name==c){return d}}return null};config.macros.formTiddler.setSelectOneValue=function(b,c){var d=b.options.length;for(var a=0;a<d;a++){b.options[a].selected=abego.getOptionsValue(b,a)==c}};config.macros.formTiddler.setSelectMultipleValue=function(c,d){var a={};for(var b=0;b<d.length;b++){a[d[b]]=true}var e=c.length;for(var b=0;b<e;b++){c.options[b].selected=!(!a[abego.getOptionsValue(c,b)])}};config.macros.formTiddler.getSelectOneValue=function(b){var a=b.selectedIndex;return(a>=0)?abego.getOptionsValue(b,a):null};config.macros.formTiddler.getSelectMultipleValue=function(c){var a=[];var d=c.length;for(var b=0;b<d;b++){if(c.options[b].selected){a.push(abego.getOptionsValue(c,b))}}return a};config.macros.formTiddler.checkForExtensions=function(a,b){if(!version.extensions.DataTiddlerPlugin){config.macros.formTiddler.createErrorElement(a,"<<"+b+">> requires the DataTiddlerPlugin. (You can get it from http://tiddlywiki.abego-software.de/#DataTiddlerPlugin)");return false}return true};config.macros.formTiddler.trace=function(a){displayMessage("Trace: "+a)};config.macros.formTiddler.displayFormTiddlerError=function(a){alert("FormTiddlerPlugin Error: "+a)};config.macros.formTiddler.createErrorElement=function(a,b){return createTiddlyElement(a,"span",null,"formTiddlerError",b)};config.macros.formTiddler.getContainingTiddlerName=function(a){return story.findContainingTiddler(a).getAttribute("tiddler")};function onFormTiddlerChange(f){if(!f){f=window.event}var d=resolveTarget(f);var b=config.macros.formTiddler.getContainingTiddlerName(d);var a=config.macros.formTiddler.getter[d.type];if(a){var c=a(d);DataTiddler.setData(b,d.name,c)}else{config.macros.formTiddler.displayFormTiddlerError("No getter defined for INPUT element of type '"+d.type+"'. (Element '"+d.name+"' used in tiddler '"+b+"')")}}window.onFormTiddlerChange=onFormTiddlerChange;setStylesheet(".formTiddlerError{color: #ffffff;background-color: #880000;}","formTiddler");config.macros.checkForDataTiddlerPlugin={label:"checkForDataTiddlerPlugin",version:{major:1,minor:0,revision:0,date:new Date(2005,12,14)},prompt:"Check if the DataTiddlerPlugin exists"};config.macros.checkForDataTiddlerPlugin.handler=function(a,b,c){config.macros.formTiddler.checkForExtensions(a,config.macros.formTiddler.label)};config.macros.newTiddlerWithForm={label:"newTiddlerWithForm",version:{major:1,minor:0,revision:1,date:new Date(2006,1,6)},prompt:"Creates a new Tiddler with a <<formTiddler ...>> macro"};config.macros.newTiddlerWithForm.handler=function(place,macroName,params){var i=0;var formTemplateName=undefined;if(i<params.length){formTemplateName=params[i];i++}if(!formTemplateName){config.macros.formTiddler.createErrorElement(place,"No form template specified in <<"+macroName+">>.");return}var buttonLabel=undefined;if(i<params.length){buttonLabel=params[i];i++}if(!buttonLabel){config.macros.formTiddler.createErrorElement(place,"No button label specified in <<"+macroName+">>.");return}var tiddlerNameScript=undefined;var askUser=false;if(i<params.length){tiddlerNameScript=params[i];i++;if(i<params.length&&params[i]=="askUser"){askUser=true;i++}}if(!readOnly){var onClick=function(){var tiddlerName=undefined;if(tiddlerNameScript){try{tiddlerName=eval(tiddlerNameScript)}catch(ex){}}if(!tiddlerName||askUser){tiddlerName=prompt("Please specify a tiddler name.",askUser?tiddlerName:"")}while(tiddlerName&&store.getTiddler(tiddlerName)){tiddlerName=prompt("A tiddler named '"+tiddlerName+"' already exists.\n\nPlease specify a tiddler name.",tiddlerName)}if(tiddlerName){var body="<<formTiddler [["+formTemplateName+"]]>>";var tags=[];store.saveTiddler(tiddlerName,tiddlerName,body,config.options.txtUserName,new Date(),tags);story.displayTiddler(null,tiddlerName,1)}};createTiddlyButton(place,buttonLabel,buttonLabel,onClick)}};
//%/
Risk Management Matrix
''7.5.3.1 Identification''
The organization shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification.

The organization shall establish documented procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product [see 6.4 d)].

''7.5.3.2 Traceability''

''7.5.3.2.1 General''
The organization shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required (see 4.2.4, 8.3 and 8.5).

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE Configuration management is a means by which identification and traceability can be maintained.

''7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices''
In defining the records required for traceability, the organization shall include records of all components, materials and work environment conditions, if these could cause the medical device not to satisfy its specified requirements.
The organization shall require that its agents or distributors maintain records of the distribution of medical
devices to allow traceability and that such records are available for inspection.
Records of the name and address of the shipping package consignee shall be maintained (see 4.2.4).

''7.5.3.3 Status identification''
The organization shall identify the product status with respect to monitoring and measurement requirements.
The identification of product status shall be maintained throughout production, storage, installation and
servicing of the product to ensure that only product that has passed the required inspections and tests (or
released under an authorized concession) is dispatched, used or installed.
$\large \alpha$ = \alpha
$\large \beta$ = \beta
$\large \gamma$ = \gamma
$\large \delta$ = \delta
$\large \epsilon$ = \epsilon
$\large \zeta$ = \zeta
$\large \eta$ = \eta
$\large \theta$ = \theta
$\large \iota$ = \iota
$\large \kappa$ = \kappa
$\large \lambda$ = \lambda
$\large \mu$ = \mu
$\large \nu$ = \nu
$\large \xi$ = \xi
$\large \pi$ = \pi
$\large \rho$ = \rho
$\large \sigma$ = \sigma
$\large \tau$ = \tau
$\large \upsilon$ = \upsilon
$\large \phi$ = \phi
$\large \chi$ = \chi
$\large \psi$ = \psi
$\large \omega$ = \omega
$\large \Gamma$ = \Gamma
$\large \Delta$ = \Delta
$\large \Theta$ = \Theta
$\large \Lambda$ = \Lambda
$\large \Xi$ = \Xi
$\large \Pi$ = \Pi
$\large \Sigma$ = \Sigma
$\large \Upsilon$ = \Upsilon
$\large \Phi$ = \Phi
$\large \Psi$ = \Psi
$\large \Omega$ = \Omega
|~ViewToolbar|closeTiddler +editTiddler +cloneTiddler > fields publishTiddler pubRev revisions syncing permalink references jump closeOthers snapshotPrint|
|~EditToolbar|+saveTiddler saveDraft -cancelTiddler deleteTiddler|
|~RevisionToolbar|> fields revert|
A ''Track I Inspection'' is a limitted inspection of a manufacturrs quality system performed by the FDA every two years.

Routine inspections generally include a review of the following firm activities:
* Submissions and changes to cleared [[510(k)]]'s
* Complaint handling processes
* Medical Device Reporting
* Device Tracking
* Failure investigations
* In-process and finished device testing
* Change Control Procedures
* Process Validation
* Component Control
* Planned and periodic audits
* Recalls
* Corrective and preventive actions
* Written procedures
Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the [[Design History File]] (DHF).
!Attention points
The intent of design validation is to make sure that the [[Design Output]] or specificaton complies with the user needs and intended use
Design teams should ensure that design validation includes the following:
* Validation Training
* Validation activities
** Under defined operating conditions
** On initial production units, lots, batches or their equivalents
** Under actial or simulated conditions
** With any software
** With a review of all risk analysis
* Master validation plan which will:
** Establish validation criteria
** Establish validation assumptions and expectations
** Identify validation personnel, their qualifications and responsibilities
** Identify design personnel, their qualifications and responsibilities
* Testing, which requires appropriate testing of
** The finished device
** All user inputs under normal, abnormal and absurd conditions
** Device outputs against expected outputs
** Equipment
** Beta testing or clinical evaluation when appropriate
** Explanations, Corrections and retesting of all unexpected results
* Master validation and test plans should
** Consider any [[Premarket notification]] documentation requirements
** Be formed according to written and approved test plans or protocols
** Ensure identified risks and hazards are fully tested
* Documentation (considered [[Controlled Document]]ation) which records testing:
** Identification of the device
** Methods used in the validation
** Dates
** Names of persons who performed the validation
* Validation review
** Appropriate individuals will review and approve all validation activities, including master validation plan, test plan, test results, and any retesting after corrective actions or changes.
* Software Validation is crucial part of the 510K.
* Software is not equal to System: distinguish System Requirements from Software Requirements
* Software Validation is not equal to Product Validation. SW Validation is covered by Subsystem and System Verification together.
These regulations implement the FDA's responsibilities for and authority over radiologic medical devices.
In mathematics, a surface integral is a definite integral taken over a surface (which may be a curve set in space); it can be thought of as the double integral analog of the line integral. Given a surface, one may integrate over its scalar fields (that is, functions which return numbers as values), and vector fields (that is, functions which return vectors as values).

Surface integrals have applications in physics, particularly with the classical theory of electromagnetism. The definition of surface integral relies on splitting the surface into small surface elements:

<<image /static/files/Math/800px-Surface_integral_illustration.png width:400>>

An illustration of a single surface element. These elements are made infinitesimally small, by the limiting process, so as to approximate the surface:
<<image /static/files/Math/429px-Surface_integral.png width:400>>
//(1) Limitation of useful beam//
The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any [[SID]].

The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam.

The [[AKR]] due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic image receptor shall not exceed 3.34 * 10-3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor.

Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information required in [[1020.30(g)]].

Additionally, the manufacturer shall provide to users, under [[1020.30(h)(1)(i)]], precautions concerning the importance of remote control operation.
Click the "new tiddler" button towards the top right of the screen to write something in your space. You'll need to give it a title, some content and, optionally, some tags that will help you identify it later.

!Stuck for ideas?
Not sure what to write about? Not sure what to keep in your space? Other people use ~TiddlySpace for almost anything. How about some of the following:

* [[Save interesting sites|http://bookmarks.tiddlyspace.com]], images or articles from around the web so that you can refer back to them.
* [[Record your family tree|http://familytree.tiddlyspace.com]], store notes on long lost relatives or ancestors and map their relationship to you.
* [[Make up a pocketbook|http://pocketbook.tiddlyspace.com]] to store some useful information in, then print it out, [[fold it up|http://www.pocketmod.com/]], and take it with you.
* [[Plan your holiday|http://the-web-is-your-oyster.tiddlyspace.com/]], record where you're planning to go, note down places of interest and refer back to it later.
* [[Create a mindmap|http://mindmaps.tiddlyspace.com/]] to visualise your inner thoughts and see how they relate to each other.
* [[Set up a questionnaire|http://questionnaire.tiddlyspace.com/]] and get all your friends to answer it.

If you don't like any of those ideas, you can still use this space directly to keep notes and link them together, make a todo list and keep track of everything you're doing, or any one of a hundred million other things.

Still stuck? Check out the @featured space for more suggestions.

You can also [[socialise with others|How to socialise]].
Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
!Attention points
* The FDA expects the following elements in change control:
** Description of the change
** Identification f the affected documents
** Signature of the approving individuals
** Approval date
** Effective date of the change
* Document changes should be in control over the following documents:
** [[CFR 21-820.30b - Design and development planning]]
** [[CFR 21-820.30c - Design Input]]
** [[CFR 21-820.30d - Design Output]]
** [[CFR 21-820.30e - Design Review]]
** [[CFR 21-820.30e - Design Review]]
** [[CFR 21-820.30f - Design Verification]]
** [[CFR 21-820.30g - Design Validation]]
** Approval of the [[Design Master Record]] or 820.40
** Equipment maintenance and inspection activities 820.70g
** Calibration performance 820.72b
** Approval of process validation 820.75a
** Performance of validated processes 820.75b
** Release of finished devices 820.80d
** Device acceptance activities performed 820.80e
** Authoization to use nonconforming products 820.90b
** Laberling inspection 820
/***
|''Name''|TiddlySpaceViewTypes|
|''Version''|0.6.0|
|''Status''|@@beta@@|
|''Description''|Provides TiddlySpace specific view types|
|''Author''|Jon Robson|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/TiddlySpaceViewTypes.js|
|''Requires''|TiddlySpaceConfig TiddlySpaceTiddlerIconsPlugin|
!Usage
Provides replyLink, spaceLink and SiteIcon view types.
!!SiteIcon view parameters
* labelPrefix / labelSuffix : prefix or suffix the label with additional text. eg. labelPrefix:'modified by '
* spaceLink: if set to "yes" will make any avatars link to the corresponding space. {{{<<originMacro spaceLink:yes>>}}}

!Code
***/
//{{{
(function($) {

var tiddlyspace = config.extensions.tiddlyspace;
var originMacro = config.macros.tiddlerOrigin;
var tweb = config.extensions.tiddlyweb;

config.macros.view.replyLink = {
	locale: {
		label: "Reply to this tiddler"
	}
};

var _replyButtons = [];
var _replyInitialised, _replyScriptLoaded;
config.macros.view.views.replyLink = function(value, place, params, wikifier,
		paramString, tiddler) {
	var valueField = params[0];
	var imported;
	if(valueField == "title") { // special casing for imported tiddlers
		var localTitle = tiddler.title;
		var serverTitle = tiddler.fields["server.title"];
		if(serverTitle && localTitle != serverTitle) {
			value = serverTitle ? serverTitle : localTitle;
			imported = true;
		}
	} else {
		title = tiddler[valueField] ? tiddler[valueField] : tiddler.fields[valueField];
	}
	var args = paramString.parseParams("anon")[0];
	var label = (args.label) ? args.label : config.macros.view.replyLink.locale.label;
	var space;
	if(tiddler) {
		var bag = tiddler.fields["server.bag"];
		space = tiddlyspace.resolveSpaceName(bag);
	}
	var container = $('<span class="replyLink" />').appendTo(place)[0];

	tweb.getUserInfo(function(user) {
		if ((!user.anon) && ((space && user.name != space &&
				user.name != tiddlyspace.currentSpace.name) || imported)) {
			var link = $("<a />")
				.text(config.macros.view.replyLink.locale.label)
				.appendTo(container)[0];

			if(typeof(createReplyButton) === "undefined") {
				_replyButtons.push(link);
			}
			if(_replyInitialised) {
				createReplyButton(link);
			} else if(!_replyScriptLoaded) {
				_replyScriptLoaded = true;
				$.getScript("/bags/common/tiddlers/_reply-button.js",
					function() {
						_replyInitialised = true;
						for(var i = 0; i < _replyButtons.length; i++) {
							createReplyButton(_replyButtons[i]);
						}
						_replyButtons = [];
					});
			}
		}
	});

};

config.macros.view.views.spaceLink = function(value, place, params, wikifier,
		paramString, tiddler) {
		var spaceName = tiddlyspace.resolveSpaceName(value);
		var isBag = params[0] == "server.bag" && value === spaceName ? true : false;
		var args = paramString.parseParams("anon")[0];
		var titleField = args.anon[2];
		var labelField = args.labelField ? args.labelField[0] : false;
		var label;
		if(labelField) {
			label = tiddler[labelField] ? tiddler[labelField] : tiddler.fields[labelField];
		} else {
			label = args.label ? args.label[0] : false;
		}
		var title = tiddler[titleField] ? tiddler[titleField] : tiddler.fields[titleField];

		var link = createSpaceLink(place, spaceName, title, label, isBag);
		if(args.external && args.external[0] == "no") {
			$(link).click(function(ev) {
				var el = $(ev.target);
				var title = el.attr("tiddler");
				var bag = el.attr("bag");
				var space = el.attr("tiddlyspace");
				bag = space ? space + "_public" : bag;
				if(title && bag) {
					ev.preventDefault();
					tiddlyspace.displayServerTiddler(el[0], title,
						"bags/" + bag);
				}
				return false;
			});
		}
};

config.macros.view.views.SiteIcon = function(value, place, params, wikifier,
		paramString, tiddler) {
	var options = originMacro.getOptions(paramString);
	if(!tiddler || value == "None") { // some core tiddlers lack modifier
		value = false;
	}
	var field = params[0];
	if(field == "server.bag") {
		options.notSpace = !originMacro._isSpace(value);
	}
	tiddlyspace.renderAvatar(place, value, options);
};

})(jQuery);
//}}}
<svg xmlns="http://www.w3.org/2000/svg" xmlns:xl="http://www.w3.org/1999/xlink" version="1.1" viewBox="78 222 60 60" 
width="30" height="30">
<g stroke="none" stroke-opacity="1" stroke-dasharray="none" fill="none" fill-opacity="1">
	<g>
		<path d="M 107.92718 244.14815 L 86.651474 222.89253 L 78.85206 230.69925 L 100.120415 251.9476 L 78.774 273.27396 
		L 86.57342 281.08075 L 107.927216 259.74707 L 129.39981 281.19946 L 137.19922 273.39267 L 115.73397 251.94763 
		L 137.121155 230.58054 L 129.32175 222.77374 Z" fill="black" class="glyph"/>
	</g>
</g>
</svg>
[[Management with executive responsibility]] shall [[Establish]] its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

* [[Quality Policy]]
** Must be established by management with executive responsibility.
** Must be understood, implemented, and maintained at all levels of the organization.
* Must establish and maintain an adequate organizational structure, including Appropriate responsibility, authority, and interrelation of personnel
** Adequate resources
** Appointed management representative
* Management Review
** Management with executive responsibility shall review the suitability and effectiveness of the quality system
** At defined intervals
** With sufficient frequency
** According to established procedures
/***
|''Name''|ToggleTiddlerPrivacyPlugin|
|''Version''|0.7.1|
|''Status''|@@beta@@|
|''Description''|Allows you to set the privacy of new tiddlers and external tiddlers within an EditTemplate, and allows you to set a default privacy setting|
|''CoreVersion''|2.6.1|
|''Requires''|TiddlySpaceConfig|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/ToggleTiddlerPrivacyPlugin.js|
!Notes
When used in conjunction with TiddlySpaceTiddlerIconsPlugin changing the privacy setting will also interact with any privacy icons.

Currently use of
{{{<<setPrivacy defaultValue:public>>}}} is in conflict with {{{<<newTiddler fields:"server.workspace:x_private">>}}}

There is an option, found in the tweak tab of the backstage, called txtPrivacyMode. Set this to either ''public'' or ''private'' depending on your security preference. If you choose not to set it then it will default to ''public''.
!Params
defaultValue:[private|public]
Allows you to set the default privacy value (Default is private)

!Code
***/
//{{{
(function($) {

	var tiddlyspace = config.extensions.tiddlyspace,
		macro;
	macro = config.macros.setPrivacy = {
		handler: function(place, macroName, params, wikifier, paramString, tiddler) {
			if(readOnly) {
				return;
			}
			var el = $(story.findContainingTiddler(place)),
				args = paramString.parseParams("name",
					null, true, false, true)[0],
				container = $("<div />").
					addClass("privacySettings").
					appendTo(place)[0],
				currentSpace = tiddlyspace.currentSpace.name,
				currentBag = tiddler ? tiddler.fields["server.bag"] : false,
				// XXX: is the following reliable?
				isNewTiddler = el.hasClass("missing") || !currentBag,
				tiddlerStatus = tiddlyspace.getTiddlerStatusType(tiddler),
				customFields = el.attr("tiddlyfields"),
				defaultValue = "public",
				options = config.macros.tiddlerOrigin ?
						config.macros.tiddlerOrigin.getOptions(paramString) :
						{};
			customFields = customFields ? customFields.decodeHashMap() : {};
			if(isNewTiddler || !["public", "private", "unsyncedPrivate",
					"unsyncedPublic"].contains(tiddlerStatus)) {
				if(args.defaultValue) {
					defaultValue = args.defaultValue[0].toLowerCase();
				} else {
					defaultValue = config.options.chkPrivateMode ?
							"private" : "public";
				}
				defaultValue = defaultValue ?
						"%0_%1".format(currentSpace, defaultValue) :
						customFields["server.bag"];
				this.createRoundel(container, tiddler, currentSpace,
						defaultValue, options);
			}
		},
		updateEditFields: function(tiddlerEl, bag) {
			var saveBagField = $('[edit="server.bag"]', tiddlerEl),
				saveWorkspaceField = $('[edit="server.workspace"]', tiddlerEl),
				input = $("<input />").attr("type", "hidden"),
				workspace = "bags/" + bag;
			if(saveBagField.length === 0) {
				input.clone().attr("edit", "server.bag").val(bag).
					appendTo(tiddlerEl);
			} else {
				saveBagField.val(bag);
			}
			// reset to prevent side effects
			$(tiddlerEl).attr("tiddlyFields", "");
			if(saveWorkspaceField.length === 0) {
				input.clone().attr("edit", "server.workspace").
					val(workspace).appendTo(tiddlerEl);
			} else {
				saveWorkspaceField.val(workspace);
			}
		},
		setBag: function(tiddlerEl, newBag, options) {
			var bagStatus,
				title = $(tiddlerEl).attr("tiddler"),
				tiddler = store.getTiddler(title),
				originButton = $(".originButton", tiddlerEl)[0],
				refreshIcon,
				newWorkspace = "bags/" + newBag,
				rPrivate = $("input[type=radio].isPrivate", tiddlerEl),
				rPublic = $("input[type=radio].isPublic", tiddlerEl);
			refreshIcon = function(type) {
				var originMacro = config.macros.tiddlerOrigin;
				if(originButton && originMacro) {
					options.noclick = true;
					originMacro.showPrivacyRoundel(tiddler, type,
							originButton, options);
				}
			};
			macro.updateEditFields(tiddlerEl, newBag);
			if(tiddler) {
				tiddler.fields["server.bag"] = newBag;
				// for external tiddlers
				tiddler.fields["server.workspace"] = newWorkspace;
			}
			if(newBag.indexOf("_public") > -1) {
				rPrivate.attr("checked", false);
				rPublic.attr("checked", true);
				bagStatus = "public";
			} else {
				rPublic.attr("checked", false); // explicitly do this for ie
				rPrivate.attr("checked", true);
				bagStatus = "private";
			}
			refreshIcon(bagStatus);
		},
		createRoundel: function(container, tiddler, currentSpace,
							   defaultValue, options) {
			var privateBag = "%0_private".format(currentSpace),
				publicBag = "%0_public".format(currentSpace),
				rbtn = $("<input />").attr("type", "radio").
					attr("name", tiddler.title),
				el = story.findContainingTiddler(container);
			rbtn.clone().val("private").addClass("isPrivate").
				appendTo(container);
			$("<label />").text("private").appendTo(container); // TODO: i18n
			rbtn.clone().val("public").addClass("isPublic")
				.appendTo(container);
			$("<label />").text("public").appendTo(container); // TODO: i18n
			$("[type=radio]", container).click(function(ev) {
				var btn = $(ev.target);
				tiddler.fields["server.page.revision"] = "false";
				if(btn.hasClass("isPrivate")) { // private button clicked.
					$(el).addClass("isPrivate").removeClass("isPublic");
					macro.setBag(el, privateBag, options);
				} else {
					$(el).addClass("isPublic").removeClass("isPrivate");
					macro.setBag(el, publicBag, options);
				}
			});
			window.setTimeout(function() {
				macro.setBag(el, defaultValue, options);
			}, 100);
			// annoyingly this is needed as customFields are added to end of EditTemplate so are not present yet
			// and don't seem to respect any existing customFields.
		}
	};

}(jQuery));
//}}}
{{{
config.macros.FlvFragment = {
  handler: function (place, macroName, params, wikifier, paramString, tiddler)
  {
     var movie;

     if (params[0] != null)
     {
           movie = params[0];
     }

     resultString = '<html>';
     resultString += '<embed ';
     resultString += 'src="/static/mediaplayer/player.swf"'
     resultString += 'width="640"';
     resultString += 'height="390"';
     resultString += 'allowscriptaccess="always"';
     resultString += 'allowfullscreen="true"';
     resultString += 'id="player1"';
     resultString += 'name="player1"';
     resultString += 'flashvars="file=';
     resultString += movie;
     resultString += '"&dock=true&menu=false"';
     resultString += '/>';
     resultString += '</html>';

     wikify(resultString,place);
   }
 }
}}}
''7.5.1.1 General requirements''

The organization shall plan and carry out production and service provision under controlled conditions.

Controlled conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of documented procedures, documented requirements, work instructions, and reference materials and reference measurement procedures as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement,
f) the implementation of release, delivery and post-delivery activities, and
g) the implementation of defined operations for labelling and packaging.

The organization shall establish and maintain a record (see 4.2.4) for each batch of medical devices that provides traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved.

NOTE A batch can be a single medical device
A ''Table-Top Inspection'' is an inspection strategy of reviewing a firms written procedures and perhaps records from a fixed location, such as an office or table-top and not performing audits or practices at the location in which they were created or implemented
''6.3 Infrastructure''

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable

a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).

The organization shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality.

Records of such maintenance shall be maintained (see [[4.2.4 Control of records|ISO13485 - 4.2.4 Control of records]]).
Abbreviation for [[Design History File]]

/***
|''Name''|ErrorHandlerPlugin|
|''Version''|0.4.3|
|''Author''|Jon Robson|
|''Description''|Localised tiddler save errors including edit conflict resolution.|
|''CoreVersion''|2.6.1|
|''Requires''|TiddlySpaceConfig|
***/
//{{{
(function($) {

var tiddlyspace = config.extensions.tiddlyspace;
var currentSpace = tiddlyspace.currentSpace.name;
tiddlyspace.getLocalTitle = function(title, workspace, suffix) {
	var endsWith = config.extensions.BinaryTiddlersPlugin.endsWith;
	if(!suffix) {
		var isPublic = endsWith(workspace, "_public");
		suffix = tiddlyspace.resolveSpaceName(workspace);
		if(currentSpace == suffix) {
			suffix = isPublic ? "public" : "private";
		} else {
			suffix = "@%0".format(suffix);
		}
	}
	return "%0 *(%1)*".format(title, suffix);
};

var sssp = config.extensions.ServerSideSavingPlugin;

var msgs = config.messages.editConflict = {
	loading: "Loading..",
	resolve: "[[Edit Conflict]]@glossary: this tiddler may have been changed by someone else.",
	reviewDiff: "review (recommended)",
	reviewDiffTooltip: "review changes made to this tiddler",
	reviewDiffError: "error retrieving revision.",
	save: "overwrite",
	saveTooltip: "make this revision the top revision of this tiddler",
	discard: "cancel",
	discardTooltip: "undo changes to this tiddler and get most recent version",
	diffTitle: "%0",
	diffFieldTitle: "%0 - fields",
	diffTextTitle: "%0 - text",
	updating: "updating your version...",
	diffHeader: ["Review the changes that have been made whilst you were editing this tiddler. ",
		"Fold relevant changes back into your version.\n",
		"{{removed{Red}}} highlight shows content removed. ",
		"{{added{Green}}} highlight shows content added.\n"].join(""),
	diffTextHeader: "View changes in text",
	diffFieldsHeader: "View changes in fields"
};

var plugin = config.extensions.errorHandler = {
	diffTags: ["excludeLists", "excludeMissing", "excludeSearch"],
	displayMessage: function(message, tiddler, context) {
		var desc = context && context.httpStatus ? context.statusText :
			sssp.locale.connectionError;
		var reportArea = plugin.reportError(tiddler.title);
		var msg = $("<div />").appendTo(reportArea);
		if(message == "saveConflict") {
			wikify(msgs.resolve, msg[0]);
			var choiceArea = $("<div />").appendTo(reportArea)[0];
			plugin.editConflictHandler(choiceArea, tiddler);
		} else {
			msg.text(sssp.locale[message].format(tiddler.title, desc));
		}
	},
	editConflictHandler: function(container, tiddler) {
		var title = tiddler.title;
		var myrev = tiddler.fields["server.page.revision"];
		// note user now needs to edit, fix problem and save. 
		// TODO: make sure this gets reset in save callback
		store.getTiddler(title).fields["server.page.revision"] = "false";

		var diffBtn = createTiddlyButton(container, msgs.reviewDiff, msgs.reviewDiffTooltip, function(ev) {
			var title = $(ev.target).data("title");
			plugin.displayDiff(ev.target, store.getTiddler(title), myrev);
		});
		var saveBtn = createTiddlyButton(container, msgs.save, msgs.saveTooltip, function(ev) {
				var title = $(ev.target).data("title");
				var tid = store.saveTiddler(store.getTiddler(title));
				autoSaveChanges(null, [tid]);
			});
		var ignoreBtn = createTiddlyButton(container, msgs.discard, msgs.discardTooltip, function(ev) {
			var title = $(ev.target).text(msgs.updating).data("title");
			plugin.resetToServerVersion(store.getTiddler(title));
		});
		$([diffBtn, ignoreBtn, saveBtn]).data("title", title);
	},
	getDiffTiddlerTexts: function(diffText) {
		var chunks = diffText.split("\n  \n");
		if(chunks.length < 2) {
			return [chunks[0], ""];
		} else {
			var diffFieldsText = "{{diff{\n%0\n}}}".format(chunks[0]);
			diffText = '{{diff{\n%0\n}}}'.format(chunks.splice(1, chunks.length).join("\n"));
			return [diffText, diffFieldsText];
		}
	},
	makeDiffTiddler: function(title, diff) {
		var newTiddler = new Tiddler(title);
		var tags = plugin.diffTags;
		newTiddler.text = msgs.loading;
		newTiddler.fields.doNotSave = true;
		newTiddler.tags = diff ? tags.concat(["diff"]) : tags;
		newTiddler = store.saveTiddler(newTiddler);
		$.extend(store.getTiddler(title).fields,
			config.defaultCustomFields); // allow option to save it
		return newTiddler;
	},
	displayDiff: function(src, tiddler, latestRevision) {
		var adaptor = tiddler.getAdaptor();
		var title = tiddler.title;
		var ts = new Date().formatString("0hh:0mm:0ss");
		var suffix = "edit conflict %0".format(ts);
		var diffTitle = tiddlyspace.getLocalTitle(msgs.diffTitle.format(title), "", suffix);
		var diffTextTitle = tiddlyspace.getLocalTitle(msgs.diffTextTitle.format(title), "", suffix);
		var diffFieldsTitle = tiddlyspace.getLocalTitle(msgs.diffFieldTitle.format(title), "", suffix);
		plugin.makeDiffTiddler(diffTextTitle, true);
		plugin.makeDiffTiddler(diffFieldsTitle, true);
		var newTiddler = plugin.makeDiffTiddler(diffTitle, false);
		newTiddler.text = ['%0\n<<slider chkViewDiffText "%1" "%2">>\n',
			'<<slider chkViewDiffField "%3" "%4">>'].join("").
			format(msgs.diffHeader, diffTextTitle, msgs.diffTextHeader,
				diffFieldsTitle, msgs.diffFieldsHeader);
		store.saveTiddler(newTiddler);

		var callback = function(r) {
			var text = plugin.getDiffTiddlerTexts(r);
			store.getTiddler(diffTextTitle).text = text[0];
			store.getTiddler(diffFieldsTitle).text = text[1];
			story.refreshTiddler(diffTitle, null, true);
		};
		var workspace = "bags/%0".format(tiddler.fields["server.bag"]);
		ajaxReq({
			type: "get",
			dataType: "text",
			url: "/diff?format=unified&rev1=%0/%1/%2&rev2=%0/%1".format(workspace, title, latestRevision),
			success: callback,
			error: function() {
				displayMessage(msgs.reviewDiffError);
			}
		});
		story.displayTiddler(src, diffTitle);
	},
	resetToServerVersion: function(tiddler) {
		var adaptor = tiddler.getAdaptor();
		var ctx = { 
			host: tiddler.fields["server.host"],
			workspace: "bags/" + tiddler.fields["server.bag"]
		};
		adaptor.getTiddler(tiddler.title, ctx, null, function(context) {
			store.saveTiddler(context.tiddler);
			story.refreshTiddler(tiddler.title);
			store.setDirty(false);
		});
	},
	reportError: function(title) {
		var el = story.getTiddler(title);
		if(!el) {
			el = story.displayTiddler(null, title);
		}
		return $("<div />").addClass("error annotation").prependTo(el)[0];
	}
};

sssp.reportFailure = function(message, tiddler, context) {
	config.options.chkViewDiffText = config.options.chkViewDiffText === undefined ?
		true : config.options.chkViewDiffText;
	config.options.chkViewDiffFields = config.options.chkViewDiffFields || false;
	plugin.displayMessage(message, tiddler, context);
};

})(jQuery);
//}}}
config.macros.OpenID={};
merge(config.macros.OpenID,{
	titleOpenID:"",
	buttonOpenIDText:"Login",
	buttonOpenIDToolTip:"Click to use OpenID Login" 
});

config.macros.OpenID.handler=function(place,macroName,params,wikifier,paramString,tiddler,errorMsg){
	var w = new Wizard();
	var me = config.macros.OpenID;
	w.createWizard(place,me.titleOpenID);
	w.addStep(null,"<!--<img width='150px' src='http://openid.net/wp-content/uploads/2007/10/openid_big_logo_text.png'/><br />--><input name='open_id_login' value='%0' size=40 style='background: rgb(255, 255, 255) url(http://www.openid.net/login-bg.gif) no-repeat scroll 0pt 50%; -moz-background-clip: -moz-initial; -moz-background-origin: -moz-initial; -moz-background-inline-policy: -moz-initial; color: rgb(0, 0, 0); padding-left: 18px;'/>".format([decodeURIComponent(cookieString(document.cookie).txtUserName)]));
	w.setButtons([
		{caption: me.buttonOpenIDText, tooltip: me.buttonOpenIDToolTip, onClick: function(){config.macros.OpenID.login(w);  } }
	]);
};

config.macros.OpenID.login = function (w) {
	var iframe = document.createElement("iframe");
	iframe.style.display = "none";
	iframe.src = url+"plugins/OpenID/files/openid/try_auth.php?action=verify&openid_identifier="+w.formElem.open_id_login.value;
	document.body.appendChild(iframe);
	iframe.onload = function() {
		// this is not working properly.
		if(iframe.src.indexOf("finish_auth.php")){
			window.location = iframe.src;	
		}
	};
	document.body.appendChild(iframe);
}

//}}}
The first assumption is that developer productivity declines with a constant rate $r$:

(1) $\Large \frac{dP(t)}{dt}$ = $\large -r \cdot P(t)$

Divide by $P(t)$:

(2) $\Large \frac{1}{P(t)}$ $\large \cdot$ $\Large \frac{dP(t)}{dt}$ = $\large -r$

(3) $\large \frac{dP(t)}{P(t)}$ = $\large -r dt$

(4) $\large \int \frac{dP(t)}{P(t)}$ = $-r \int t dt$

(5) $\large ln(P(t))= -rt +C $

Exponantiate both sides:

(6) $\large P(t) = e^{-rt}e^C $

(7) $\large P(t) = e^C \cdot e^{-rt} =e^C \cdot 1$

As P(0) = P_0 we get:

(8) $\large P(0) = e^C \cdot e^{-r \cdot 0} = e^C \cdot 1$

So $\large P(0) = e^C$ giving:
(9) $\large P(t) = P_0 \cdot e^{-rt}$

See: http://en.wikipedia.org/wiki/Exponential_decay#Solution_of_the_differential_equation
''7.5.2.1 General requirements''
The organization shall validate any processes for production and service provision where //the resulting output cannot be verified by subsequent monitoring or measurement//. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Examples:
* sterilization
* maintenance of specified codition 
* aseptic processig
* sealing
* heat treatment

Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.

The organization shall establish documented procedures for the validation of the application of computer software (and changes to such software and/or its application) for production and service provision that affect the ability of the product to conform to specified requirements. Such software applications shall be validated prior to initial use.

Records of validation shall be maintained (see 4.2.4)

''7.5.2.2. Particular requirements for sterile medical devices''
The organization shall establish documented procedures for the validation of sterilization processes.
Sterilization processes shall be validated prior to initial use.
Records of validation of each sterilization process shall be maintained (see 4.2.4).
//(2) Further means for limitation//
Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of paragraphs [[(b)(4)|CFR 1020.32 Fluoroscopic equipment (b)(4) Fluoroscopy and radiography using the fluoroscopic imaging]] and (b)(5).

Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or the capability of a visible area of ''//greater than 300 square cm//'', shall be provided with means for stepless adjustment of the x-ray field.

Equipment with a fixed SID and the capability of a visible area of no ''//greater than 300 square cm//'' shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to ''//125 square cm or less//''.

Stepless adjustment shall, at the greatest [[SID]], provide continuous field sizes from the maximum obtainable to a field size containable in a square of 5 cm by 5 cm.

This paragraph does not apply to non-image-intensified fluoroscopy.
The dot product of two vectors a = [a1, a2, ... , an] and b = [b1, b2, ... , bn] is defined as:

$\Large    \mathbf{a}\cdot \mathbf{b} = \sum_{i=1}^n a_ib_i = a_1b_1 + a_2b_2 + \cdots + a_nb_n$

where Σ denotes summation notation and n is the dimension of the vector space.

In dimension 2, the dot product of vectors [a,b] and [c,d] is ac + bd. Similarly, in a dimension 3, the dot product of vectors [a,b,c] and [d,e,f] is ad + be + cf. For example, the dot product of two three-dimensional vectors [1, 3, −5] and [4, −2, −1] is

$\Large    [1, 3, -5] \cdot [4, -2, -1] = (1 \times 4) + (3 \times -2) + (-5 \times -1) = 4 - 6 + 5 = 3$.

The dot product can also be obtained via transposition and matrix multiplication as follows:

$\Large \mathbf{b}^\mathrm{T}\mathbf{a} = \mathbf{a}^\mathrm{T}\mathbf{b}$,

where both vectors are interpreted as column vectors, and aT denotes the transpose of a, in other words the corresponding row vector.
A ''Design Input Requirements Control Matrix'' is a [[Controlled Document]] that identifies in a tabular format each device input requirements. The matrix may be devided into individual sections for major elements of the input requirements. For example:
* Intended use
* User needs
* Patient needs
* Operational requirements
* Standard requirements
* Safety requirements
* Performance requirements
* Environmental requirements
* Labelling requirements
* Packaging requirements
* Documentation requirements
The document will be subject to version control.
These regulations implement the FDA's criteria for and authority over class III devices requiring manufacturers requirements to submit [[PMA]] on appropriate devices.

<<tiddler [[Premarket approval]]>>
/***
|''Name''|TiddlySpaceTiddlerIconsPlugin|
|''Version''|0.8.10|
|''Status''|@@beta@@|
|''Author''|Jon Robson|
|''Description''|Provides ability to render SiteIcons and icons that correspond to the home location of given tiddlers|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/TiddlySpaceTiddlerIconsPlugin.js|
|''Requires''|TiddlySpaceConfig BinaryTiddlersPlugin ImageMacroPlugin TiddlySpacePublishingCommands|
!Notes
{{{<<tiddlerOrigin>>}}} shows the origin of the tiddler it is being run on.
In TiddlySpace terms this means it will determine whether the tiddler is external, public or private.
Where private it will analyse whether a public version exists and distinguish between the different scenarios.
If a tiddler is external, the SiteIcon of that external space will be shown

!Parameters
width / height : define a width or height of the outputted icon
label: if label parameter is set to yes, a label will accompany the icon.
!Code
***/
//{{{
(function($) {

if(!config.macros.image) {
	throw "Missing dependency: ImageMacroPlugin";
}

var imageMacro = config.macros.image;
var tiddlyspace = config.extensions.tiddlyspace;
var tweb = config.extensions.tiddlyweb;
var cmds = config.commands;
var cmd = cmds.publishTiddler;
tiddlyspace.resolveSpaceName = function(value) {
	var endsWith = config.extensions.BinaryTiddlersPlugin.endsWith;
	if(value) {
		value = value.indexOf("bags/") === 0 ? value.substr(5) : value;
		value = value.indexOf("recipes/") === 0 ? value.substr(8) : value;
		if(value.indexOf("@") === 0) {
			value = value.substr(1);
		}
		if(endsWith(value, "_public")) {
			value = value.substr(0, value.length - 7);
		} else if(endsWith(value, "_private")) {
			value = value.substr(0, value.length - 8);
		}
		value = value.toLowerCase();
	}
	return value;
};

tiddlyspace.renderAvatar = function(place, value, options) {
	options = options ? options : {};
	options.labelOptions = options.labelOptions ? options.labelOptions : { include: false, height: 48, width: 48 };
	options.imageOptions = options.imageOptions ? options.imageOptions : {};
	options.imageOptions.altImage = "/bags/common/tiddlers/defaultUserIcon";
	var container = $('<div class="siteIcon" />').appendTo(place);
	value = tiddlyspace.resolveSpaceName(value);

	tweb.getStatus(function(status) {
		var link, noLabel;
		if(!value || value == config.views.wikified.defaultModifier ||
			value == config.views.wikified.shadowModifier) {
			var icon = config.views.wikified.shadowModifier == value ? "shadowIcon" : "missingIcon";
			if(store.tiddlerExists(icon)) {
				imageMacro.renderImage(container, icon, options.imageOptions);
			} else {
				noLabel = true;
			}
		} else {
			var spaceURI;
			if(value != tiddlyspace.currentSpace.name) {
				spaceURI = options.notSpace ? tiddlyspace.getHost(status.server_host) :
					tiddlyspace.getHost(status.server_host, value);
			}
			link = spaceURI ? $("<a />").attr("href", spaceURI) : $("<span />");
			link.text(value);

			var imageOptions = options.imageOptions;
			if(options.spaceLink && !imageOptions.link) {
				imageOptions.link = spaceURI;
			}
			var avatar = options.notSpace ? false : value;
			var uri = tiddlyspace.getAvatar(status.server_host, avatar);
			imageMacro.renderImage(container, uri, options.imageOptions);
			if(!value) {
				value = "tiddlyspace";
			}
		}
		if(!noLabel && options.labelOptions.include) {
			var prefix = $("<span />").text(options.labelOptions.prefix || "")[0];
			var suffix = $("<span />").text(options.labelOptions.suffix || "")[0];
			$('<div class="label" />').append(prefix).append(link).
				append(suffix).appendTo(container);
		}
	});
	if(value) {
		var prefix = options.labelOptions.prefix || "";
		var suffix = options.labelOptions.suffix || "";
		var label = "%0%1%2".format(prefix, value, suffix);
		$(container).attr("title", label);
	}
};

var originMacro = config.macros.tiddlerOrigin = {
	locale: {
		"shadow": "shadow tiddler",
		"missing": "missing tiddler",
		"private": "private",
		"unknown": "unknown state",
		"public": "public",
		"unsyncedPrivate": "unsynced and private",
		"unsyncedPublic": "unsynced and public",
		externalPrefix: "from ",
		externalBagSuffix: " bag",
		externalSuffix: " space",
		publishPrivateDeletePrivate: "Are you sure you want to make this tiddler public?",
		moveToPrivate: "Are you sure you want to make this tiddler private? Only members will be able to see it.",
		pleaseWait: "please wait..",
		keepPublic: "keep public",
		cannotPublishDirtyTiddler: "The current tiddler is unsaved so cannot be published. Please save the tiddler first.",
		keepPrivate: "keep private",
		makePublic: "make public",
		makePrivate: "make private"
	},
	handler: function(place, macroName, params,wikifier, paramString, tiddler){
		var adaptor = tiddler.getAdaptor();
		var btn = $("<div />").addClass("originButton").attr("params", paramString).
			attr("refresh", "macro").attr("macroName", macroName).appendTo(place)[0];
		$(btn).data("tiddler", tiddler);
		originMacro.refresh(btn);
	},
	refresh: function(btn) {
		$(btn).empty();
		var paramString = $(btn).attr("params");
		var tiddler = $(btn).data("tiddler");
		var options = originMacro.getOptions(paramString);
		var type = tiddlyspace.getTiddlerStatusType(tiddler);
		originMacro.renderIcon(tiddler, type, btn, options);
	},
	getOptions: function(paramString) {
		paramString = "%0 label:no width:48 height:48 spaceLink:yes preserveAspectRatio:yes".format(paramString);
		var parsedParams = paramString.parseParams("name");
		var params = parsedParams[0].name;
		var options = {
			labelOptions: originMacro._getLabelOptions(parsedParams),
			imageOptions: imageMacro.getArguments(paramString, []),
			noclick: parsedParams[0].interactive &&
				parsedParams[0].interactive[0] == "no" ? true : false
		};
		if(!options.noclick) {
			var spaceLink = parsedParams[0].spaceLink;
			options.spaceLink = spaceLink && spaceLink[0] == "no" ? false : true;
		} else {
			options.spaceLink = false;
		}
		return options;
	},
	_getLabelOptions: function(parsedParams) {
		parsedParams = parsedParams[0];
		var includeLabel = !parsedParams.label || ( parsedParams.label && parsedParams.label[0] == "yes" );
		var prefix = parsedParams.labelPrefix ? parsedParams.labelPrefix[0] : false;
		var suffix = parsedParams.labelSuffix ? parsedParams.labelSuffix[0] : false;
		return { include: includeLabel, suffix: suffix, prefix: prefix };
	},
	_isSpace: function(value) {
		value = value ? value : "";
		var endsWith = config.extensions.BinaryTiddlersPlugin.endsWith;
		if(endsWith(value, "_private") || endsWith(value, "_public")) {
			return true;
		} else {
			return false;
		}
	},
	renderIcon: function(tiddler, type, button, options) {
		var locale = originMacro.locale;
		originMacro.annotateTiddler(button, type);
		if(type != "external") {
			originMacro.showPrivacyRoundel(tiddler, type, button,
				options);
		} else {
			var prefix = options.labelOptions.prefix, suffix = options.labelOptions.suffix;
			var space = tiddler.fields["server.bag"];
			options.notSpace = !originMacro._isSpace(space);
			options.labelOptions.prefix = prefix ? prefix : locale.externalPrefix;
			options.labelOptions.suffix = suffix ? suffix : (options.notSpace ? locale.externalBagSuffix : locale.externalSuffix);

			tiddlyspace.renderAvatar(button, space, options);
		}
	},
	showPrivacyRoundel: function(thisTiddler, privacyType, button, options) {
		// there is a public tiddler as well as the current tiddler!
		// TODO: not this is not enough.. we also need to check if the public tiddler is the same as..
		// .. the private tiddler to determine whether this is a draft
		// use of hashes would be useful here.
		$(button).empty();
		var icon = "%0Icon".format(privacyType);
		if(privacyType.indexOf("unsynced") === 0 && !store.tiddlerExists(icon)) {
			icon = "unsyncedIcon";
		}
		if(privacyType == "shadow") {
			if(!store.tiddlerExists(icon)) {
				icon = "bags/tiddlyspace/tiddlers/SiteIcon";
			}
		}
		if(privacyType == "missing" && !store.tiddlerExists(icon)) {
			return; // the user is not making use of the missingIcon
		} else {
			imageMacro.renderImage(button, icon, options.imageOptions);
			originMacro.showLabel(button, privacyType, options.labelOptions);
			var cmd = originMacro.iconCommands[privacyType];
			if(cmd && thisTiddler && !options.noclick) {
				$(button).click(function(ev) {
					cmd(ev, thisTiddler);
				});
			}
		}
	},
	annotateTiddler: function(place, type) {
		var tidEl = $(story.findContainingTiddler(place));
		tidEl.
			removeClass("private public external privateAndPublic privateNotPublic shadow").
			addClass(type);
	},
	showLabel: function(button, type, options) {
		var locale = originMacro.locale;
		var label = options.label ? options.label : locale[type];
		label = label ? label : locale.unknown;
		if(options && options.include) {
			$('<div class="roundelLabel" />').html(label).appendTo(button);
		}
		$(button).attr("title", label);
	},
	confirm: function(ev, msg, onYes, options) {
		options = options ? options : {};
		onYes = onYes ? onYes : function(ev) {};
		var btn = $(".originButton", $(ev.target).parents())[0];
		var popup = Popup.create(btn);
		$(popup).addClass("confirmationPopup");
		$("<div />").addClass("message").text(msg).appendTo(popup);
		$("<button />").addClass("button").text(options.yesLabel || "yes").appendTo(popup).click(onYes);
		$("<button />").addClass("button").text(options.noLabel || "no").click(function(ev) {
			Popup.remove();
		}).appendTo(popup);
		Popup.show();
		ev.stopPropagation();
		return false;
	},
	alert: function(ev, msg) {
		var popup = Popup.create(ev.target);
		$(popup).addClass("confirmationPopup alert");
		$("<div />").addClass("message").text(msg).appendTo(popup);
		Popup.show();
		ev.stopPropagation();
	},
	reportDirty: function(el) {
		originMacro.alert(el, originMacro.locale.cannotPublishDirtyTiddler);
	},
	iconCommands: {
		"public": function(ev, tiddler) {
			if(!readOnly) {
				var locale = originMacro.locale;
				var msg = locale.moveToPrivate;
				if(story.isDirty(tiddler.title)) {
					originMacro.reportDirty(ev);
				} else {
					originMacro.confirm(ev, msg, function(ev) {
						var target = $(ev.target);
						var onComplete = function(info) {};
						var privateBag = cmd.toggleBag(tiddler, "private");
						cmd.moveTiddler(tiddler, {
							title: tiddler.title,
							fields: { "server.bag": privateBag }
						}, onComplete);
					}, { yesLabel: locale.makePrivate, noLabel: locale.keepPublic });
				}
			}
		},
		"private": function(ev, tiddler) {
			if(!readOnly) {
				var locale = originMacro.locale;
				var adaptor = tiddler.getAdaptor();
				var publishTo = tiddler.fields["publish.name"] || tiddler.title;
				var workspace = "bags/%0".format(tiddler.fields["server.bag"]);
				tiddler.fields["server.workspace"] = workspace;
				var publicBag = cmd.toggleBag(tiddler, "public");
				var msg;
				msg = locale.publishPrivateDeletePrivate;
				var title = tiddler.title;
				var newTitle = publishTo || tiddler.title;
				tiddler.fields["server.page.revision"] = "false";
				store.addTiddler(tiddler);
				if(story.isDirty(tiddler.title)) {
					originMacro.reportDirty(ev);
				} else {
					originMacro.confirm(ev, msg, function(ev) {
						var onComplete = function(info) {};
						cmd.moveTiddler(tiddler, {
							title: newTitle,
							fields: { "server.bag": publicBag }
						}, onComplete);
					}, { yesLabel: locale.makePublic, noLabel: locale.keepPrivate });
				}
			}
		}
	}
};

})(jQuery);
//}}}
/***
|''Name''|ServerSideSavingPlugin|
|''Description''|server-side saving|
|''Author''|FND|
|''Version''|0.6.4|
|''Status''|stable|
|''Source''|http://svn.tiddlywiki.org/Trunk/association/plugins/ServerSideSavingPlugin.js|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''CoreVersion''|2.5.3|
|''Keywords''|serverSide|
!Notes
This plugin relies on a dedicated adaptor to be present.
The specific nature of this plugin depends on the respective server.
!Revision History
!!v0.1 (2008-11-24)
* initial release
!!v0.2 (2008-12-01)
* added support for local saving
!!v0.3 (2008-12-03)
* added Save to Web macro for manual synchronization
!!v0.4 (2009-01-15)
* removed ServerConfig dependency by detecting server type from the respective tiddlers
!!v0.5 (2009-08-25)
* raised CoreVersion to 2.5.3 to take advantage of core fixes
!!v0.6 (2010-04-21)
* added notification about cross-domain restrictions to ImportTiddlers
!To Do
* conflict detection/resolution
* rename to ServerLinkPlugin?
* document deletion/renaming convention
!Code
***/
//{{{
(function($) {

readOnly = false; //# enable editing over HTTP

var plugin = config.extensions.ServerSideSavingPlugin = {};

plugin.locale = {
	saved: "%0 saved successfully",
	saveError: "Error saving %0: %1",
	saveConflict: "Error saving %0: edit conflict",
	deleted: "Removed %0",
	deleteError: "Error removing %0: %1",
	deleteLocalError: "Error removing %0 locally",
	removedNotice: "This tiddler has been deleted.",
	connectionError: "connection could not be established",
	hostError: "Unable to import from this location due to cross-domain restrictions."
};

plugin.sync = function(tiddlers) {
	tiddlers = tiddlers && tiddlers[0] ? tiddlers : store.getTiddlers();
	$.each(tiddlers, function(i, tiddler) {
		var changecount = parseInt(tiddler.fields.changecount, 10);
		if(tiddler.fields.deleted === "true" && changecount === 1) {
			plugin.removeTiddler(tiddler);
		} else if(tiddler.isTouched() && !tiddler.doNotSave() &&
				tiddler.getServerType() && tiddler.fields["server.host"]) {
			delete tiddler.fields.deleted;
			plugin.saveTiddler(tiddler);
		}
	});
};

plugin.saveTiddler = function(tiddler) {
	try {
		var adaptor = this.getTiddlerServerAdaptor(tiddler);
	} catch(ex) {
		return false;
	}
	var context = {
		tiddler: tiddler,
		changecount: tiddler.fields.changecount,
		workspace: tiddler.fields["server.workspace"]
	};
	var serverTitle = tiddler.fields["server.title"]; // indicates renames
	if(!serverTitle) {
		tiddler.fields["server.title"] = tiddler.title;
	} else if(tiddler.title != serverTitle) {
		return adaptor.moveTiddler({ title: serverTitle },
			{ title: tiddler.title }, context, null, this.saveTiddlerCallback);
	}
	var req = adaptor.putTiddler(tiddler, context, {}, this.saveTiddlerCallback);
	return req ? tiddler : false;
};

plugin.saveTiddlerCallback = function(context, userParams) {
	var tiddler = context.tiddler;
	if(context.status) {
		if(tiddler.fields.changecount == context.changecount) { //# check for changes since save was triggered
			tiddler.clearChangeCount();
		} else if(tiddler.fields.changecount > 0) {
			tiddler.fields.changecount -= context.changecount;
		}
		plugin.reportSuccess("saved", tiddler);
		store.setDirty(false);
	} else {
		if(context.httpStatus == 412) {
			plugin.reportFailure("saveConflict", tiddler);
		} else {
			plugin.reportFailure("saveError", tiddler, context);
		}
	}
};

plugin.removeTiddler = function(tiddler) {
	try {
		var adaptor = this.getTiddlerServerAdaptor(tiddler);
	} catch(ex) {
		return false;
	}
	context = { tiddler: tiddler };
	context.workspace = tiddler.fields["server.workspace"];
	var req = adaptor.deleteTiddler(tiddler, context, {}, this.removeTiddlerCallback);
	return req ? tiddler : false;
};

plugin.removeTiddlerCallback = function(context, userParams) {
	var tiddler = context.tiddler;
	if(context.status) {
		if(tiddler.fields.deleted === "true") {
			store.deleteTiddler(tiddler.title);
		} else {
			plugin.reportFailure("deleteLocalError", tiddler);
		}
		plugin.reportSuccess("deleted", tiddler);
		store.setDirty(false);
	} else {
		plugin.reportFailure("deleteError", tiddler, context);
	}
};

plugin.getTiddlerServerAdaptor = function(tiddler) { // XXX: rename?
	var type = tiddler.fields["server.type"] || config.defaultCustomFields["server.type"];
	return new config.adaptors[type]();
};

plugin.reportSuccess = function(msg, tiddler) {
	displayMessage(plugin.locale[msg].format([tiddler.title]));
};

plugin.reportFailure = function(msg, tiddler, context) {
	var desc = (context && context.httpStatus) ? context.statusText :
		plugin.locale.connectionError;
	displayMessage(plugin.locale[msg].format([tiddler.title, desc]));
};

config.macros.saveToWeb = { // XXX: hijack existing sync macro?
	locale: { // TODO: merge with plugin.locale?
		btnLabel: "save to web",
		btnTooltip: "synchronize changes",
		btnAccessKey: null
	},

	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		createTiddlyButton(place, this.locale.btnLabel, this.locale.btnTooltip,
			plugin.sync, null, null, this.locale.btnAccessKey);
	}
};

// hijack saveChanges to trigger remote saving
var _saveChanges = saveChanges;
saveChanges = function(onlyIfDirty, tiddlers) {
	if(window.location.protocol == "file:") {
		_saveChanges.apply(this, arguments);
	} else {
		plugin.sync(tiddlers);
	}
};

// override removeTiddler to flag tiddler as deleted -- XXX: use hijack to preserve compatibility?
TiddlyWiki.prototype.removeTiddler = function(title) { // XXX: should override deleteTiddler instance method?
	var tiddler = this.fetchTiddler(title);
	if(tiddler) {
		tiddler.tags = ["excludeLists", "excludeSearch", "excludeMissing"];
		tiddler.text = plugin.locale.removedNotice;
		tiddler.fields.deleted = "true"; // XXX: rename to removed/tiddlerRemoved?
		tiddler.fields.changecount = "1";
		this.notify(title, true);
		this.setDirty(true);
	}
};

// hijack ImportTiddlers wizard to handle cross-domain restrictions
var _onOpen = config.macros.importTiddlers.onOpen;
config.macros.importTiddlers.onOpen = function(ev) {
	var btn = $(resolveTarget(ev));
	var url = btn.closest(".wizard").find("input[name=txtPath]").val();
	if(window.location.protocol != "file:" && url.indexOf("://") != -1) {
		var host = url.split("/")[2];
		var macro = config.macros.importTiddlers;
		if(host != window.location.host) {
			btn.text(macro.cancelLabel).attr("title", macro.cancelPrompt);
			btn[0].onclick = macro.onCancel;
			$('<span class="status" />').text(plugin.locale.hostError).insertAfter(btn);
			return false;
		}
	}
	return _onOpen.apply(this, arguments);
};

})(jQuery);
//}}}
/***
|''Name''|GroupByPlugin|
|''Description''|Mimics allTags macro to provide ways of creating lists grouping tiddlers by any field|
|''Version''|0.6.1|
|''Author''|Jon Robson|
|''Status''|beta|
!Usage
{{{<<groupBy tags>>}}}
mimics allTags macro

{{{<<groupBy server.bag>>}}}
groups by the server.bag field (this version contains TiddlySpace specific code for turning a bag into a space name)

{{{groupBy modified dateFormat:"YYYY"}}}
group tiddlers by year.

{{{<<groupBy tags exclude:excludeLists exclude:systemConfig>>}}}
group tiddlers by tag but exclude the tags with values excludeLists and systemConfig

Within that group you can also exclude things by filter
{{{groupBy modifier filter:[tag[film]]}}}
will group tiddlers tagged with film by modifier.
***/
//{{{
(function($) {
var taglocale = config.views.wikified.tag;
var macro = config.macros.groupBy = {
	locale: {
		tooltip: "all tiddlers in group %0",
		noTiddlers: "no tiddlers",
		openAllText: taglocale.openAllText,
		openAllTooltip: taglocale.openAllTooltip,
		openTiddler: "open tiddler with title %0"
	},
	morpher: {
		// TODO: note currently the following 2 morphers are TiddlySpace specific and probably should be in separate plugin
		"server.workspace": function(value, options) {
			return macro.morpher["server.bag"](value.replace("bags/", "").replace("recipes/", ""));
		},
		"server.bag": function(value, options) {
			if(typeof(value) !== "string") {
				return false;
			} else if(value.indexOf("_public") === -1 && value.indexOf("_private") === -1) {
				value = "*%0".format(value); // add star for non-space bags.
			}
			return value.replace("_public", "").replace("_private", "");
		},
		created: function(value, options) {
			return value.formatString(options.dateFormat || "DD MMM YYYY");
		},
		modified: function(value, options) {
			return macro.morpher.created(value, options);
		}
	},

	handler: function(place, macroName, params, wikifier, paramString) {
		var field = params[0] || "server.workspace";
		var dateFormat = params[1] || "DD MMM YYYY";
		var container = $("<div />").attr("macroName", macroName).addClass("groupBy").
			attr("refresh", "macro").attr("fieldName", field).
			attr("paramString", paramString).
			attr("dateFormat", dateFormat).appendTo(place)[0];
		macro.refresh(container);
	},
	isTypeArray: function(value) {
		var valueType = typeof value;
		if(valueType === "object" && typeof value.length === "number" &&
			!(value.propertyIsEnumerable("length")) &&
			typeof value.splice === "function") { //is Array
			return true;
		} else {
			return false;
		}
	},
	_onClickGroup: function(ev, options) {
		var i, target = ev.target, locale = macro.locale;
		var tiddlers = $(target).closest(".templateContainer").data("tiddlers");
		var popup = $(Popup.create(target)).addClass("taggedTiddlerList")[0];
		var value = $(target).attr("value");
		var openAll = createTiddlyButton($("<li />").appendTo(popup)[0],
			locale.openAllText.format(value), locale.openAllTooltip);
		$(openAll).click(function(ev) {
			story.displayTiddlers(ev.target, tiddlers);
			return false;
		});
		var listBreak = $("<li />").addClass("listBreak").html("<div />").appendTo(popup);
		for(i = 0; i < tiddlers.length; i++) {
			var item = $("<li />").appendTo(popup)[0];
			var template = store.getTiddlerText(options.template) || macro.template;
			wikify(template, item, null, tiddlers[i]);
		}
		listBreak.clone().appendTo(popup);
		$(createTiddlyLink($("<li />").appendTo(popup)[0], value, false)).
			text(locale.openTiddler.format(value));
		Popup.show();
		ev.stopPropagation();
		return false;
	},
	_refresh: function(container, tiddlers, options) {
		var totalGroups = 0, locale = macro.locale, i, j;
		var excludeValues = options.exclude;
		var values = {}, value_ids = [];
		var field = options.field;
		var morpher = macro.morpher[field] || function(value) {
			return value;
		};
		for(i = 0; i < tiddlers.length; i++) {
			var tiddler = tiddlers[i];
			var value = tiddler[field] || tiddler.fields[field];
			value = macro.isTypeArray(value) ? value : [ value ];
			for(j = 0; j < value.length; j++) {
				var v = morpher(value[j], options);
				if(v && $.inArray(v, excludeValues) === -1) {
					totalGroups += 1;
					if(!values[v]) {
						values[v] = [];
					}
					values[v].push(tiddler);
					value_ids.pushUnique(v);
				}
			}
		}
		var ul = $("<ul />").appendTo(container)[0];
		if(totalGroups === 0) {
			$("<li />").addClass("listTitle").text(locale.noTiddlers);
		}
		value_ids = value_ids.sort();
		var groupTemplate = store.getTiddlerText(options.groupTemplate);
		var onClick = function(ev) {
			macro._onClickGroup(ev, options);
		};
		for(i = 0; i < value_ids.length; i++) {
			var title = value_ids[i];
			var info = getTiddlyLinkInfo(title);
			tiddlers = values[title];
			var btn = createTiddlyButton($("<li />").appendTo(ul)[0],
				"%0 (%1)".format(title, tiddlers.length), locale.tooltip.format(title), null, info.classes);
			if(groupTemplate) {
				$(btn).empty();
				wikify(groupTemplate, btn, null, tiddlers[0]);
			}
			$(btn).click(onClick).attr("value", title).attr("refresh", "link").attr("tiddlyLink", title);
			$(btn).addClass("templateContainer").data("tiddlers", tiddlers);
		}
	},
	refresh: function(container) {
		container = $(container).empty();
		var paramString = container.attr("paramString");
		var args = paramString.parseParams("name", null, true, false, true)[0];
		var options = { field: container.attr("fieldName"), dateFormat: container.attr("dateFormat"), exclude: args.exclude || [],
			template: args.template ? args.template[0] : false, groupTemplate: args.groupTemplate ? args.groupTemplate[0] : "" };
		var tiddlers = args.filter ? store.filterTiddlers(args.filter[0]) : store.getTiddlers("title");
		macro._refresh(container, tiddlers, options);
	},
	template: "<<view title link>>"
};

}(jQuery));
//}}}
{{{
config.macros.BBClonePlugin = {
  handler: function (place, macroName, params, wikifier, paramString, tiddler)
  {
     var uri = "/bbclone/count.php?tiddler=Tiddler:[%0]".
         format([tiddler.title]);
     jQuery.get(uri); 
   }
 }
}}}
/***
|''Name''|TiddlySpaceFilters|
|''Description''|provide TiddlySpace-specific filter extensions|
|''Author''|Jon Robson|
|''Version''|0.6.1|
|''Status''|@@beta@@|
|''CoreVersion''|2.6.2|
|''Requires''|TiddlySpaceConfig|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
!Usage
{{{
<<tsList Private>>
<<tsList Public>>
<<tsList Draft>>
}}}
!Code
***/
//{{{
(function($) {

var tiddlyspace = config.extensions.tiddlyspace;
var privateBag = tiddlyspace.getCurrentBag("private");
var publicBag = tiddlyspace.getCurrentBag("public");

config.filterHelpers = {
	is: {
		"private": function(tiddler) {
			var bag = tiddler.fields["server.bag"];
			return bag == privateBag;
		},
		"public": function(tiddler) {
			var bag = tiddler.fields["server.bag"];
			return bag == publicBag;
		},
		draft: function(tiddler) {
			var fields = tiddler.fields;
			var bag = fields["server.bag"];
			return (privateBag == bag && fields["publish.name"]) ? true : false;
		},
		local: function(tiddler) {
			return config.filterHelpers.is["public"](tiddler) ||
				config.filterHelpers.is["private"](tiddler);
		},
		unsynced: function(tiddler) {
			return tiddler ? tiddler.isTouched() : false;
		}
	}
};

config.filters.is = function(results, match) {
	var candidates = store.getTiddlers("title");
	var type = match[3];
	for (var i = 0; i < candidates.length; i++) {
		var tiddler = candidates[i];
		var helper = config.filterHelpers.is[type];
		if(helper && helper(tiddler)) {
			results.pushUnique(tiddler);
		}
	}
	return results;
};

})(jQuery);
//}}}
5.4.2 Quality management system planning

Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in [[4.1|ISO13485 - 4.1 General Requirements]], as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
/***
|''Name''|DiffFormatter|
|''Description''|highlighting of text comparisons|
|''Author''|FND|
|''Version''|0.9.0|
|''Status''|beta|
|''Source''|http://svn.tiddlywiki.org/Trunk/contributors/FND/formatters/DiffFormatter.js|
|''CodeRepository''|http://svn.tiddlywiki.org/Trunk/contributors/FND/|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''Keywords''|formatting|
!Description
Highlights changes in a unified [[diff|http://en.wikipedia.org/wiki/Diff#Unified_format]].
!Notes
Based on Martin Budden's [[DiffFormatterPlugin|http://svn.tiddlywiki.org/Trunk/contributors/MartinBudden/formatters/DiffFormatterPlugin.js]].
!Usage
The formatter is applied to blocks wrapped in <html><code>{{{diff{..}}}</code></html> within tiddlers tagged with "diff".
!Revision History
!!v0.9 (2010-04-07)
* initial release; fork of DiffFormatterPlugin
!StyleSheet
.diff { white-space: pre; font-family: monospace; }
.diff ins, .diff del { display: block; text-decoration: none; }
.diff ins { background-color: #dfd; }
.diff del { background-color: #fdd; }
.diff .highlight { background-color: [[ColorPalette::SecondaryPale]]; }
!Code
***/
//{{{
(function() {

config.shadowTiddlers.StyleSheetDiffFormatter = store.getTiddlerText(tiddler.title + "##StyleSheet");
store.addNotification("StyleSheetDiffFormatter", refreshStyles);

var formatters = [{
		name: "diffWrapper",
		match: "^\\{\\{diff\\{\n", // XXX: suboptimal
		termRegExp: /(.*\}\}\})$/mg,
		handler: function(w) {
			var el = createTiddlyElement(w.output, "div", null, "diff");
			w.subWikifyTerm(el, this.termRegExp);
		}
	}, {
		name: "diffRange",
		match: "^(?:@@|[+\\-]{3}) ",
		lookaheadRegExp: /^(?:@@|[+\-]{3}) .*\n/mg,
		handler: function(w) {
			createTiddlyElement(w.output, "div", null, "highlight").
				innerHTML = "&#8230;";
			this.lookaheadRegExp.lastIndex = w.matchStart;
			var lookaheadMatch = this.lookaheadRegExp.exec(w.source);
			if(lookaheadMatch && lookaheadMatch.index == w.matchStart) {
				w.nextMatch = this.lookaheadRegExp.lastIndex;
			}
		}
	}, {
		name: "diffAdded",
		match: "^\\+",
		termRegExp: /(\n)/mg,
		handler: function(w) {
			var el = createTiddlyElement(w.output, "ins", null, "added");
			w.subWikifyTerm(el, this.termRegExp);
		}
	}, {
		name: "diffRemoved",
		match: "^-",
		termRegExp: /(\n)/mg,
		handler: function(w) {
			var el = createTiddlyElement(w.output, "del", null, "removed");
			w.subWikifyTerm(el, this.termRegExp);
		}
	}
];

config.parsers.diffFormatter = new Formatter(formatters);
config.parsers.diffFormatter.format = "diff";
config.parsers.diffFormatter.formatTag = "diff";

})();
//}}}
The Design Control Activities start with the //output// of the concept phase as the [[Design Input]], this output is sometimes called the [[Product Proposal]]. The product proposal may consist of the following:
* A comprehensive descriptiion of the functional characteristics and physical features of the device's design
* Initial identification of users needs, an initial safety assesmen, regulatory requirements and business requirements
* Review and approval of the product proposal by appropriate management.
Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.

!Attention Points
* During [[management review|CFR 21-820.20c - Management review]] the procedures, instructions, forms and checklists should be discussed. The status of each item, its latest version and date may be attached to the report.
* During [[QSIT|Quality System Inspection Technique]] the following is subject to verification:
** A [[Quality Policiy]], [[Management Review|CFR 21-820.20c - Management review]] and quality audit  procedures, [[Quality Plan]] and quality system procedures and instructions are defined and documented
* A [[Quality Policy]] has been implemented
* The firms [[organizational structure|CFR 21-820.20b - Organization]] provides the management responsibilities, authorities and necessary resroueces
* A management representattive with appropriate purview has been identified
* Management review includes documented reviews of the suitability and effectviveness of the quality system
* [[Quality Audits]] and if appropriate reaudits of identified nonconformances are conducted.
ISO 9000 is a group of generic international standards for quality management, quality assurance and implementation of a quality system.
A specific generic international conformance standard to which a firm involved with design, development, production, installation and servicing may comply and be found compliant.
''5.5.3 Internal communication''

Top management shall ensure that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the quality management
system.
• [[ISO]] is a International Standard published by the International Organization for
Standardization
• [[EN]] is a European Standard published by European Commision for Standardization
• [[NEN]] is a Dutch Standard published by the ”nederlands normalisatie instituut”
• Harmonized Standard is a standard accepted for regulatory CE marking compliance.
Compliance with harmonized standards provides a presumption of conformity with the
corresponding requirements of harmonization legislation (e.g. Medical Device
Directive)
• The EN [[ISO 13485:2012]] is a harmonized standard (for EU)
• For the 13485 the following standards exist
– [[ISO13485:2003]] valid for e.g. Canada
– EN [[ISO 13485:2012]] valid for EU
– Difference between 2003 and 2012 only on Annex ZA, ZB & ZC
• FDA does not recognize (yet) the [[ISO 13485]] as standard.
/***
|''Name''|TiddlyFileImporter|
|''Version''|0.3.8|
|''Author''|Ben Gillies|
|''Type''|plugin|
|''Description''|Upload a TiddlyWiki file to TiddlyWeb, and import the tiddlers.|
!Usage
Upload a TiddlyWiki file to TiddlyWeb, and import the tiddlers.
!Requires
tiddlyweb
tiddlywebplugins.reflector
!Code
***/
//{{{
(function($){
if(!version.extensions.TiddlyFileImporter)
{ //# ensure that the plugin is only installed once
	version.extensions.TiddlyFileImporter = { installed: true };
}

config.macros.fileImport = {
	reflectorURI: '/reflector?csrf_token=%0',
	incorrectTypeError: 'Incorrect File Type. You must upload a TiddlyWiki',
	uploadLabel: 'Upload',
	uploadLabelPrompt: 'Import tiddlers from this TiddlyWiki',
	step1FileText: 'File:',
	step1PostText: 'In the next screen you will select the tiddlers to import.',
	step1Title: 'Step 1: Pick a TiddlyWiki to import',
	step1TypeChooser: 'Import From:',
	step3Html: ['<input type="hidden" name="markList" />',
		'<input type="hidden" checked="true" name="chkSync" />',
		'<input type="hidden" name="chkSave" />',
		'<input type="hidden" name="txtSaveTiddler" />'].join(),

	handler: function(place, macroName, params, wikifier, paramString) {
		var wizard = new Wizard();
		wizard.createWizard(place, 'Import a TiddlyWiki');
		this.restart(wizard);
	},

	restart: function(wizard) {
		var me = config.macros.fileImport;
		wizard.addStep(me.step1Title, ['<input type="hidden" ',
			'name="markList" />'].join(""));
		var markList = wizard.getElement('markList');
		var uploadWrapper = document.createElement('div');
		markList.parentNode.insertBefore(uploadWrapper, markList);
		uploadWrapper.setAttribute('refresh', 'macro');
		uploadWrapper.getAttribute('macroName', 'fileImport');
		var iframeName = 'reflectorImporter' + Math.random().toString();
		me.createForm(uploadWrapper, wizard, iframeName);
		$(uploadWrapper).append('<p>' + me.step1PostText + '</p>');
		wizard.setValue('serverType', 'tiddlyweb');
		wizard.setValue('adaptor', new config.adaptors.file());
		wizard.setValue('host', config.defaultCustomFields['server.host']);
		wizard.setValue('context', {});
		var iframe = $(['<iframe name="' + iframeName + '" ',
			'style="display: none" />'].join("")).appendTo(uploadWrapper);
		var onSubmit = function(ev) {
			var uploadType = $('select[name=uploadtype]', wizard.formElem).val();
			if (uploadType == "file") {
				// set an onload ready to hijack the form
				me.setOnLoad(uploadWrapper, wizard, iframe[0]);
				wizard.importType = 'file';
				wizard.formElem.submit();
			} else {
				var csrf_token = config.extensions.tiddlyspace.getCSRFToken();
				$.ajax({
					url: "%0/reflector?csrf_token=%1".format(
						config.defaultCustomFields["server.host"], csrf_token),
					type: "POST",
					dataType: "text",
					data: {
						uri: $("input", ".importFrom", wizard.formElem).val()
					},
					success: function(data, txtStatus, xhr) {
						wizard.POSTResponse = data;
						me.importTiddlers(uploadWrapper, wizard);
					},
					error: function(xhr, txtStatus, error) {
						displayMessage(["There was an error fetching the ",
							'url: ', txtStatus].join(""));
						me.restart(wizard);
					}
				});
				return false;
			}
		};
		wizard.setButtons([{
			caption: me.uploadLabel,
			tooltip: me.uploadLabelPrompt,
			onClick: onSubmit
		}]);
		$(wizard.formElem).submit(function(ev) {
			onSubmit(ev);
			ev.preventDefault();
		});
	},

	createForm: function(place, wizard, iframeName) {
		var form = wizard.formElem;
		var me = config.macros.fileImport;
		form.action = me.reflectorURI.format(
			config.extensions.tiddlyspace.getCSRFToken());
		form.enctype = 'multipart/form-data';
		form.encoding = 'multipart/form-data';
		form.method = 'POST';
		form.target = iframeName;
		onSelectChange = function(e) {
			var changeTo = $(this).val();
			if (changeTo == "file") {
				$(".importFrom").html('%0 <input type="file" name="file" />'.
					format(me.step1FileText));
			} else {
				$(".importFrom").html('URL: <input type="text" name="uri" />'
					+ ' Do you want <a target="_blank" href="http://faq.tiddlyspace.com/How%20do%20I%20include%2Fexclude%20spaces%3F">inclusion</a> instead?');
			}
		};
		$(place).append('<span>%0</span>'.format(me.step1TypeChooser)).
			append($(['<select name="uploadtype"><option value="file" selected="selected">file',
				'<option value="uri">url</select>'].join("")).change(onSelectChange)).
			append('<div class="importFrom">%0<input type="file" name="file" /></div>'.
					format(me.step1FileText));
	},

	setOnLoad: function(place, wizard, iframe) {
		var me = config.macros.fileImport;
		var loadHandler = function() {
			me.importTiddlers.apply(this, [place, wizard, iframe]);
		};
		iframe.onload = loadHandler;
		completeReadyStateChanges = 0;
		iframe.onreadystatechange = function() {
			if (++(completeReadyStateChanges) == 5) {
				loadHandler();
			}
		};
	},

	importTiddlers: function(place, wizard, iframe) {
		var tmpStore = new TiddlyWiki();
		var POSTedWiki = "";
		if (wizard.importType == "file") {
			try {
				POSTedWiki= iframe.contentWindow
					.document.documentElement.innerHTML;
			} catch(e) {
				displayMessage(config.macros.fileImport.incorrectTypeError);
				config.macros.fileImport.restart(wizard);
				return;
			}
			// now we are done, so remove the iframe
			$(iframe).remove();
		} else {
			POSTedWiki = wizard.POSTResponse;
		}

		tmpStore.importTiddlyWiki(POSTedWiki);
		var newTiddlers = tmpStore.getTiddlers();
		var workspace = config.defaultCustomFields['server.workspace'];
		var context = {
			status: true,
			statusText: 'OK',
			httpStatus: 200,
			adaptor: wizard.getValue('adaptor'),
			tiddlers: newTiddlers
		};
		context.adaptor.store = tmpStore;
		wizard.setValue('context', context);
		wizard.setValue('workspace', workspace);
		wizard.setValue('inFileImport', true);
		config.macros.importTiddlers.onGetTiddlerList(context, wizard);
	}
};

var _onGetTiddler = config.macros.importTiddlers.onGetTiddler;
config.macros.importTiddlers.onGetTiddler = function(context, wizard) {
	if (wizard.getValue('inFileImport')) {
		var me = config.macros.importTiddlers;
		if(!context.status)
			displayMessage("Error in importTiddlers.onGetTiddler: " + context.statusText);
		var tiddler = context.tiddler;
		var fields = tiddler.fields;
		merge(fields, config.defaultCustomFields);
		fields["server.workspace"] = wizard.getValue('workspace');
		delete fields['server.permissions'];
		delete fields['server.bag'];
		fields['server.page.revision'] = 'false';
		delete fields['server.recipe'];
		fields.changecount = 1;
		store.suspendNotifications();
		store.saveTiddler(tiddler.title, tiddler.title, tiddler.text,
			tiddler.modifier, tiddler.modified, tiddler.tags, tiddler.fields,
			false, tiddler.created);
		store.resumeNotifications();
		var remainingImports = wizard.getValue("remainingImports")-1;
		wizard.setValue("remainingImports",remainingImports);
		if(remainingImports === 0) {
			if(context.isSynchronous) {
				store.notifyAll();
				refreshDisplay();
			}
			wizard.setButtons([
					{caption: me.doneLabel, tooltip: me.donePrompt, onClick: me.onClose}
				],me.statusDoneImport);
			autoSaveChanges();
		}
	} else {
		_onGetTiddler.apply(this, arguments);
	}
};

var _onCancel = config.macros.importTiddlers.onCancel;
config.macros.importTiddlers.onCancel = function(e)
{
	var wizard = new Wizard(this);
	if (!wizard.getValue('inFileImport')) {
		return _onCancel.apply(this, arguments);
	}
	var place = wizard.clear();
	config.macros.fileImport.restart(wizard);
	return false;
};

var _step3Html = config.macros.importTiddlers.step3Html;
var _onGetTiddlerList = config.macros.importTiddlers.onGetTiddlerList;
config.macros.importTiddlers.onGetTiddlerList = function(context, wizard) {
	var fileImport = config.macros.fileImport;
	var importTiddlers = config.macros.importTiddlers;
	if (wizard.getValue('inFileImport')) {
		importTiddlers.step3Html = fileImport.step3Html;
	} else {
		importTiddlers.step3Html = _step3Html;
	}
	_onGetTiddlerList.apply(this, arguments);
};
})(jQuery);
//}}}
The organization needs to distinguish between documents that will be controlled and documents that will not be included under the QMS. A document is:
* Plans, requirements, or specifications for realization or activities
* Input for a process
* Communication of information
* Sharing of knowledge, information, or data

Unlike a [[Record]] that is considered as evidence for performance of a process and records the output of a process, the document presents a specification or input for a process. 

Types of documents in an organization include: diagrams, drawings, process charts, technical specifications, product plans, DMR, quality plans, forms, checklists, routing cards, customer’s specifications, manufacturing specifications, process flow diagrams, production plans, standard procedures, quality work procedures, bills of materials, computer files, instructions, test instructions, test protocols, agreements with suppliers, approved lists of suppliers, material specifications, regulations or directives, assembly plans, internal audit plans, corrective action forms, reports of nonconformity, and international standards.

The method will relate to external documents as well. External documents will be distinguished, registered, and controlled. The method shall first identify these external documents that are part of the realization processes of the product and thus require control, for example, a drawing or product received from a customer. This is a classic external document that must be controlled for edition or revision. Examples of external documents may be drawings, packaging instructions, diagrams of production tools, quality requirements, design files, and customer’s approvals or agreements. External documents include regulatory requirements. It is necessary to verify that the updated edition of the regulations is available.
I suggest a table that will specify all the documents under the QMS. The fields of the table are:0
* Identification number
* Description or name
* Relevant process/relevant department
* Responsible for review
* Responsible for approval
* Media
* Location
* Internal/external
* Other characteristics such as public or classified
These regulations implement FDA's responsibilities and authority over medical device manufacturers management, design, development, verficiation, manufacture, validation, distributoin, installation, support, quality assurance and records for each new or listed device.

This regulation is the major regulatory thrust of day-to-day FDA oversight of device manufacturers and the focus of this book. Most of the remaining chapers are specific to the Quality System Regulation. These regulations are also the agency's attempt to harmonize medical device regulation with international quality standards, specifically ISO 9000.

The Quality System Regulations are philosophically simple:
* Comply with the regulations
* Say what you do
* Do what you say
* Document that you have done what you say

The CFR regulations described with respect to Quality System Regulations are:
<<forEachTiddler
    where
        'tiddler.tags.contains("CFR 21-820.20")'
    sortBy 
         'tiddler.title.toUpperCase()'
   write
         '"* [["+tiddler.title+"]]" + "\n"'

>>
7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
''5.5.2 Management representative''
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes:
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
b) reporting to top management on the performance of the quality management system and any need for improvement (see 8.5), and
c) ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.

NOTE The responsibility of a management representative can include liaison with external parties on matters
relating to the quality management system.
/***
|''Name''|TiddlySpaceConfig|
|''Version''|0.7.7|
|''Description''|TiddlySpace configuration|
|''Status''|stable|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/TiddlySpaceConfig.js|
|''CoreVersion''|2.6.1|
|''Requires''|TiddlyWebConfig ServerSideSavingPlugin TiddlyFileImporter|
!Code
***/
//{{{
(function($) {

var tweb = config.extensions.tiddlyweb;

var recipe = config.defaultCustomFields["server.workspace"].split("recipes/")[1];
var currentSpace; // assigned later

var disabledTabs = [];

var coreBags = ["system", "tiddlyspace"];
var systemSpaces = ["plugins", "info", "images", "theme"];
systemSpaces = $.map(systemSpaces, function(item, i) {
	return "system-%0_public".format(item);
});

// hijack search macro to add custom attributes for mobile devices
var _search = config.macros.search.handler;
config.macros.search.handler = function(place, macroName, params) {
	_search.apply(this, arguments);
	$(".searchField:input", place).
		attr({ autocapitalize: "off", autocorrect: "off" });
};

// arg is either a container name or a tiddler object
// if fuzzy is truthy, space may be inferred from workspace (for new tiddlers)
// returns space object or false
var determineSpace = function(arg, fuzzy) {
	if(typeof arg == "string") { // container name
		var space = split(arg, "_", "r");
		return ["public", "private"].contains(space.type) ? space : false;
	} else if(arg) { // tiddler
		var container = determineContainer(arg, fuzzy);
		return container ? determineSpace(container.name, fuzzy) : false;
	} else {
		return false;
	}
};

// if fuzzy is truthy, container may be inferred from workspace for new tiddlers
// returns container object or false
var determineContainer = function(tiddler, fuzzy) { // TODO: expose?
	var bag = tiddler.fields["server.bag"];
	var recipe = tiddler.fields["server.recipe"]; // XXX: unused/irrelevant/redundant!?
	if(bag) {
		return { type: "bag", name: bag };
	} else if(recipe) {
		return { type: "recipe", name: recipe };
	} else if(fuzzy) { // new tiddler
		var workspace = tiddler.fields["server.workspace"];
		if(workspace) {
			var container = split(workspace, "/", "l");
			return ["bags", "recipes"].contains(container.type) ? container : false;
		} else {
			return false;
		}
	} else {
		return false;
	}
};

// hijack removeTiddlerCallback to restore tiddler from recipe cascade -- TODO: move into TiddlyWebWiki?
var sssp = config.extensions.ServerSideSavingPlugin;
var _removeTiddlerCallback = sssp.removeTiddlerCallback;
sssp.removeTiddlerCallback = function(context, userParams) {
	var title = context.tiddler.title;
	var recipe = context.tiddler.fields["server.recipe"];
	_removeTiddlerCallback.apply(this, arguments);
	if(recipe) {
		context.workspace = "recipes/" + recipe;
		var callback = function(context, userParams) {
			if(context.status) {
				var dirty = store.isDirty();
				store.saveTiddler(context.tiddler).clearChangeCount();
				store.setDirty(dirty);
			} else {
				store.notify(title, true);
			}
		};
		context.adaptor.getTiddler(title, context, null, callback);
	}
};

// splits a string once using delimiter
// mode "l" splits at the first, "r" at the last occurrence
// returns an object with members type and name
var split = function(str, sep, mode) {
	mode = mode == "r" ? "pop" : "shift"; // TODO: use +/-1 instead of "l"/"r"?
	var arr = str.split(sep);
	var type = arr.length > 1 ? arr[mode]() : null;
	return { type: type, name: arr.join(sep) };
};

var plugin = config.extensions.tiddlyspace = {
	currentSpace: determineSpace(recipe),
	coreBags: coreBags.concat(systemSpaces),

	determineSpace: determineSpace,
	isValidSpaceName: function(name) {
		return name.match(/^[a-z][0-9a-z\-]*[0-9a-z]$/) ? true : false;
	},
	getCurrentBag: function(type) {
		return "%0_%1".format(currentSpace, type);
	},
	getCurrentWorkspace: function(type) {
		return "bags/" + this.getCurrentBag(type);
	},
	// returns the URL for a space's avatar (SiteIcon) based on a server_host
	// object and an optional space name
	// optional nocors argument prevents cross-domain URLs from being generated
	getAvatar: function(host, space, nocors) {
		if(space && typeof space != "string") { // backwards compatibility -- XXX: deprecated
			space = space.name;
		}
		var subdomain = nocors ? currentSpace : space;
		host = host ? this.getHost(host, subdomain) : "";
		var bag = space ? "%0_public".format(space) : "tiddlyspace";
		return "%0/bags/%1/tiddlers/SiteIcon".format(host, bag);
	},
	// returns the URL based on a server_host object (scheme, host, port) and an
	// optional subdomain
	getHost: function(host, subdomain) {
		if(host === undefined) { // offline
			tweb.status.server_host = {}; // prevents exceptions further down the stack -- XXX: hacky workaround, breaks encapsulation
			return null;
		}
		subdomain = subdomain ? subdomain + "." : "";
		var url = "%0://%1%2".format(host.scheme, subdomain, host.host);
		var port = host.port;
		if(port && !["80", "443"].contains(port)) {
			url += ":" + port;
		}
		return url;
	},
	disableTab: function(tabTiddler) {
		if(typeof(tabTiddler) == "string") {
			disabledTabs.push(tabTiddler);
		} else {
			for(var i = 0; i < tabTiddler.length; i++) {
				plugin.disableTab(tabTiddler[i]);
			}
		}
	},
    checkSyncStatus: function(tiddler) {
		if(tiddler) {
			var title = typeof(tiddler) === "string" ? tiddler : tiddler.title;
			var el = story.getTiddler(title) || false;
			if(el) {
				refreshElements(el);
			}
		}
	},
	isDisabledTab: function(tabTitle) {
		var match = new RegExp("(?:\\[\\[([^\\]]+)\\]\\])", "mg").exec(tabTitle);
		var tabIdentifier = match ? match[1] : tabTitle;
		return disabledTabs.contains(tabIdentifier);
	},
	getCSRFToken: window.getCSRFToken || null // this may not have been processed yet
};

currentSpace = plugin.currentSpace.name;

tweb.serverPrefix = tweb.host.split("/")[3] || ""; // XXX: assumes root handler
tweb.getStatus(function(status) {
	var url = plugin.getHost(status.server_host);
	tweb.status.server_host.url = url;
	config.messages.tsVersion = status.version;
});

if(window.location.protocol == "file:") {
	// enable AutoSave by default
	config.options.chkAutoSave = config.options.chkAutoSave === undefined ?
		true : config.options.chkAutoSave;
} else {
	// set global read-only mode based on membership heuristics
	var indicator = store.getTiddler("SiteTitle") || tiddler;
	readOnly = !(recipe.split("_").pop() == "private" ||
		tweb.hasPermission("write", indicator));
	// replace TiddlyWiki's ImportTiddlers due to cross-domain restrictions
	if(config.macros.fileImport) {
		$.extend(config.macros.importTiddlers, config.macros.fileImport);
	}
}

// hijack saveChanges to ensure SystemSettings is private by default
var _saveChanges = saveChanges;
saveChanges = function(onlyIfDirty, tiddlers) {
	if(tiddlers && tiddlers.length == 1 &&
			tiddlers[0] && tiddlers[0].title == "SystemSettings") {
		var fields = tiddlers[0].fields;
		delete fields["server.recipe"];
		fields["server.bag"] = plugin.getCurrentBag("private");
		fields["server.workspace"] = plugin.getCurrentWorkspace("private");
	}
	return _saveChanges.apply(this, arguments);
};

// ensure backstage is always initialized
// required to circumvent TiddlyWiki's read-only based handling
config.macros.backstageInit = {
	init: function() {
		showBackstage = true;
	}
};

// disable evaluated macro parameters for security reasons
config.evaluateMacroParameters = "none";
var _parseParams = String.prototype.parseParams;
String.prototype.parseParams = function(defaultName, defaultValue, allowEval,
		noNames, cascadeDefaults) {
	if(config.evaluateMacroParameters == "none") {
		arguments[2] = false;
	}
	return _parseParams.apply(this, arguments);
};

var _tabsMacro = config.macros.tabs.handler;
config.macros.tabs.handler = function(place, macroName, params) {
	var newParams = [params[0]]; // keep cookie name
	for(var i = 1; i < params.length; i += 3) {
		var tabTitle = params[i + 2];
		if(!plugin.isDisabledTab(tabTitle)){
			newParams = newParams.concat(params[i], params[i + 1], tabTitle);
		}
	}
	_tabsMacro.apply(this, [place, macroName, newParams]);
};

// disable ControlView for XHRs by default
$.ajaxSetup({
	beforeSend: function(xhr) {
		xhr.setRequestHeader("X-ControlView", "false");
	}
});
// TiddlyWeb adaptor currently still uses httpReq, which needs extra magic -- XXX: obsolete this!
var _httpReq = httpReq;
httpReq = function(type, url, callback, params, headers, data, contentType,
		username, password, allowCache) {
	headers = headers || {};
	headers["X-ControlView"] = "false";
	_httpReq.apply(this, arguments);
};

// register style sheet for backstage separately (important)
store.addNotification("StyleSheetBackstage", refreshStyles);

// option for default privacy setting
config.optionsDesc.chkPrivateMode = "Set your default privacy mode to private";
config.optionsSource.chkPrivateMode = "setting";
config.options.chkPrivateMode = config.options.chkPrivateMode || false;
saveSystemSetting("chkPrivateMode", true);
config.defaultCustomFields["server.workspace"] = plugin.
	getCurrentWorkspace(config.options.chkPrivateMode ? "private" : "public");

config.paramifiers.follow = {
	onstart: function(v) {
		if(!readOnly) {
			var bag = "%0_public".format(currentSpace);
			story.displayTiddler(null, v, DEFAULT_EDIT_TEMPLATE, null, null,
				"server.bag:%0 server.workspace:bags/%0".format(bag));
			story.setTiddlerTag(v, "follow", 1);
			story.focusTiddler(v, "text");
		}
	}
};

var fImport = config.macros.fileImport;
if(fImport) {
	fImport.uploadTo = "Upload to: ";
	var _createForm = config.macros.fileImport.createForm;
	config.macros.fileImport.createForm = function(place, wizard, iframeName) {
		var container = $("<div />").text(fImport.uploadTo).appendTo(place);
		var select = $('<select name="mode" />').appendTo(container)[0];
		$('<option value="private" selected>private</a>').appendTo(select);
		$('<option value="public">public</a>').appendTo(select);
		wizard.setValue("importmode", select);
		_createForm.apply(this, [place, wizard, iframeName]);
	};

	var _onGet = config.macros.importTiddlers.onGetTiddler;
	config.macros.importTiddlers.onGetTiddler = function(context, wizard) {
		var type = $(wizard.getValue("importmode")).val();
		var ws =  plugin.getCurrentWorkspace(type);
		wizard.setValue("workspace", ws);
		_onGet.apply(this, [context, wizard]);
	};
}

config.extensions.ServerSideSavingPlugin.reportSuccess = function(msg, tiddler) {
	plugin.checkSyncStatus(tiddler);
	msg = config.extensions.ServerSideSavingPlugin.locale[msg];
	var link = "/" + encodeURIComponent(tiddler.title);
	displayMessage(msg.format([tiddler.title]), link);
};


})(jQuery);
//}}}
''7.5.1.2.1 Cleanliness of product and contamination control''

The organization shall establish documented requirements for cleanliness of product if
a) product is cleaned by the organization prior to sterilization and/or its use, or
b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, or
c) product is supplied to be used non-sterile and its cleanliness is of significance in use, or
d) process agents are to be removed from product during manufacture.

If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4 a) and 6.4 b) do not
apply prior to the cleaning process.

''7.5.1.2.2 Installation activities''
If appropriate, the organization shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device.

If the agreed customer requirements allow installation to be performed other than by the organization or its authorized agent, the organization shall provide documented requirements for installation and verification.

Records of installation and verification performed by the organization or its authorized agent shall be maintained (see 4.2.4).

''7.5.1.2.3 Servicing activities''
If servicing is a specified requirement, the organization shall establish documented procedures, work instructions and reference materials and reference measurement procedures, as necessary, for performing servicing activities and verifying that they meet the specified requirements.

Records of servicing activities carried out by the organization shall be maintained (see 4.2.4).
NOTE Servicing can include, for example, repair and maintenance.
Space fda
In [[CFR 21-820.30f - Design Verification]] and [[CFR 21-820.30g - Design Validation]]. Design verification activities include the following:
* Verification training by the design team
* Pretesting review that consists of a complete and thorough review of the following:
** Design inputs or requirements
** Design outputs or specifications
** Assessments to ensure that the design output or specifications meet the design input or requirements
** Risk analysis and control of identified individual hazards
** All labelling against requirements, specifications and risk analysis including documentaion risk or hazards
* Master [[Verification Plan]] including the following:
** Verification criteria
** Verification assumptions and expectations
** Verification personnel, their qualifications and responsibilities
* Appropriate testing of the following:
** Individual parts elements, components, modules, software components
** All inputs under normal, abnormal and absurd conditions
** Testing deviations or failures
** Deviations or failures after approprate corrective actions
* Equipment calibrated with test equipment and controlled with appropriate requirements
* Master verification and test plans should do the following:
** Consider any [[Premarket notification]] documetation requirements
** Perform according to written and approved master verification plan and test plans
** Ensure identified risks or hazards are fully tested via written test plans
* Documentation that verifies design review and appropriate testing
** Identification of the device
** Methods used in the verification
** Dates
** Individuals performing the verification
** All verification documentation should be considered [[Controlled Document]]ation
* Verification review in which appriopriate individuals review and approve all verifictaion activities, including master verification plan, test plans, test results and any retesting after corrective actions or changes.
Under the [[QSIT]] handbook, investigators will regard [[Design Controls]] as one of the four major quality systems for each form. The following steps are performed:
# Select a single design project
# For the design project selected, verify that design control procedures that address the requirements of Section 820.30 of the regulation have been defined and documented
# Review the design plan for the selected project to understand the layout of the design and development activities including assigned responsibilities and interfaces.
## Note: Evaluate the firm's conduct of risk analysis while proceeding through the assessment of the firm's Design Control system
# Confirm that [[Design Inputs]] were established
# Verify that the [[Design Outputs]] that are essential for the proper functioning of the device were identified.
# Confirm that acceptance criteria were established prior to the performance of verification and validation activities.
# Determine if design verification confirmed that design outputs met the design input requirements. 
# Confirm that design validation data show that the approved design met the predetermined user needs and intended uses.
# Confirm that the completed design validation did not leave any unresolved discrepancies.
# If the device contains software, confirm that the software was validated.
# Confirm that risk analysis was performed.
# Determine if design validation was accomplished using initial production devices or their equivalents.
# Confirm that changes were controlled including validated or where appropriate verified
# Determine if design reviews were conducted
# Determine if the design was correctly transferred
<<image /static/files/FDA/DesignControlsDecisionFlowChart.jpg width:600>>
!Design Planning
Expectations are as follows:
* Complexity should be reflected in elaborate documentation
* Derivation of input requirements
* Robust Risk Analysis
* Inspectors may provide an [[Establishment Inspection Report]] with findings related to each of the issues found.
!Design Input
The following may be subject to review:
* Intended use
* User/Patient/Clinical issues (interviews, usability studies)
* Performance characteristics
* Safety
* Limits and tolerances
* Risk Analysis (methods and inputs)
* Toxity and biocompatibility
* Electromagnetic compatibility
* Compatibility with environment of intended use
* Human factors
* Reliability
* Physical / Chemics characteristics
* Statutory and regularatory requirements
* Volontary standards
* Sterility
* MDRs / Complaints / Failures
* Device History Files
!Design Output
* The design system identifies and defines design outputs
* Outputs are expressed and compared to inputs
* The acceptance criteria are determinded for design output
* The deisgn output has been reviewed and approved prior to release.
!Design review
* Did the manufacturer identify appropriate stages for formal design review?
* Documentation should exist that these reviews happened
* Mechanisms should ensure comprehensive and systematic review
* Appropriat organisational functions should particpate in the review
* The deisgn review system should ensure thaht the identified design inputs are addressed by the design outputs
!Design changes
Investigators want to see:
# Manufacturers producedures that defined and control design changes
# An individual who is authorized to review and approved design changes
# Indication of how the approval is documented
* The stage of the design process the firm identifies when changes to the approved design inputs begin to control
* The criteria in the design change system that are used to accept changes to approved design inputs
* The manner in which the design change system implements a change to the design inputs
* The procedures that are followed to evaluate when verification or validation of design changes are necessary.
IMPORTANT:
* Investigators are thought that all design changes must be //''verified''//
* Unless only verification can be justified and documented that all design changes must be //''validated''//
!Design verification
Investigators will want to see:
# Procedures that control design verification
# Review of the design history
# General and low level detailed documents used
They also want to see:
# Examples of significant points during verification
# Conirm the number of times that a specific input requirement has been fullfilled by the design output
# Identify whether the activities are quantitatiev of qualitative
Finally they want to see:
# The verifiation methods that have been employed to confirm that input requirements are met (e.g. usability testing)
# The verification data that show that output meets input
!Design validation
Investigators may ask the following questions:
* What evaluations where performed to assist in validating that the device deisgn meets user needs and intended uses
* What labels and labelling, packaging and so on are t be used
* What clinical data were generated from studies with approved FDA compliant protocols
* Was [[510(k)]] historical database search performed?
* Did clinical evaluatations include home use?
* Were there literature searches
* Was there any historical product knowlegde?
* Under what actual or simulated conditions was the finished device tested?
* How did the firm resolve discrepancies encountered during validation activities?
* Did discrepancy resolution necessitate a new risk analysis? If not, why not?
* Does the product contain software? How was it validated?
* How have risks been identified and analyzed (e.g. [[FTA]] [[FMECA]])
* Does the [[Design History File]] identify the dates and methods of validation?
!Design transfer
Investigators want to see:
* Procedures that control design transfer
* Typically the investigator will select one or more features and track the process to see if design transfer procedures were followed
!Design History File
Investigators will want to see how the design history file is maintained and retains the acual design history.
* The will make a list of key elemenst of the DHF
* When more devices share a common history, the FDA investigors will want to understand how commonalities are tracked
In probability theory and statistics, the variance is used as a measure of how far a set of numbers are spread out from each other. It is one of several descriptors of a probability distribution, describing how far the numbers lie from the mean (expected value). In particular, the variance is one of the moments of a distribution. In that context, it forms part of a systematic approach to distinguishing between probability distributions. While other such approaches have been developed, those based on moments are advantageous in terms of mathematical and computational simplicity.

$\Large {Var}(X) = {E}[(X - \mu)^2]$
/***
|''Name:''|MediaWikiAdaptorPlugin|
|''Description:''|Adaptor for moving and converting data from MediaWikis|
|''Author:''|Martin Budden (mjbudden (at) gmail (dot) com)|
|''Source:''|http://www.martinswiki.com/#MediaWikiAdaptorPlugin |
|''CodeRepository:''|http://svn.tiddlywiki.org/Trunk/contributors/MartinBudden/adaptors/MediaWikiAdaptorPlugin.js |
|''Version:''|0.5.8|
|''Date:''|Jul 27, 2007|
|''Comments:''|Please make comments at http://groups.google.co.uk/group/TiddlyWikiDev |
|''License:''|[[Creative Commons Attribution-ShareAlike 2.5 License|http://creativecommons.org/licenses/by-sa/2.5/]] |
|''~CoreVersion:''|2.2.0|

|''Max number of tiddlers to download''|<<option txtMediaAdaptorLimit>>|


MediaWiki REST documentation is at:
http://meta.wikimedia.org/w/api.php
http://meta.wikimedia.org/w/query.php

***/

//{{{
if(!version.extensions.MediaWikiAdaptorPlugin) {
version.extensions.MediaWikiAdaptorPlugin = {installed:true};

if(config.options.txtMediaAdaptorLimit == undefined)
	{config.options.txtMediaAdaptorLimit = '500';}
	
function MediaWikiAdaptor()
{
	this.host = null;
	this.workspace = null;
	return this;
}

MediaWikiAdaptor.serverType = 'mediawiki';
MediaWikiAdaptor.serverParsingErrorMessage = "Error parsing result from server";
MediaWikiAdaptor.errorInFunctionMessage = "Error in function MediaWikiAdaptor.%0";

MediaWikiAdaptor.doHttpGET = function(uri,callback,params,headers,data,contentType,username,password)
{
	return doHttp('GET',uri,data,contentType,username,password,callback,params,headers);
};

MediaWikiAdaptor.prototype.setContext = function(context,userParams,callback)
{
	if(!context) context = {};
	context.userParams = userParams;
	if(callback) context.callback = callback;
	context.adaptor = this;
	if(!context.host)
		context.host = this.host;
	if(!context.workspace && this.workspace)
		context.workspace = this.workspace;
	return context;
};

MediaWikiAdaptor.fullHostName = function(host)
{
	if(!host)
		return '';
	if(!host.match(/:\/\//))
		host = 'http://' + host;
	if(host.substr(host.length-1) != '/')
		host = host + '/';
	return host;
};

MediaWikiAdaptor.minHostName = function(host)
{
	return host ? host.replace(/^http:\/\//,'').replace(/\/$/,'') : '';
};

MediaWikiAdaptor.normalizedTitle = function(title)
{
	var n = title.charAt(0).toUpperCase() + title.substr(1);
	return n.replace(/\s/g,'_');
};

// Convert a MediaWiki timestamp in YYYY-MM-DDThh:mm:ssZ  format into a JavaScript Date object
MediaWikiAdaptor.dateFromTimestamp = function(timestamp)
{
	var dt = timestamp;
	return new Date(Date.UTC(dt.substr(0,4),dt.substr(5,2)-1,dt.substr(8,2),dt.substr(11,2),dt.substr(14,2)));
};

MediaWikiAdaptor.anyChild = function(obj)
{
	for(var key in obj) {
		return obj[key];
	}
	return null;
};

MediaWikiAdaptor.prototype.openHost = function(host,context,userParams,callback)
{
	this.host = MediaWikiAdaptor.fullHostName(host);
	context = this.setContext(context,userParams,callback);
	if(context.callback) {
		context.status = true;
		window.setTimeout(function() {callback(context,userParams);},0);
	}
	return true;
};

MediaWikiAdaptor.getWorkspaceId = function(workspace)
{
	var workspaces = {
		"media": -2, "special":-1,
		"":0, "talk":1,"user":2,"user talk":3,"meta":4,"meta talk":5,"image":6,"image talk":7,
		"mediawiki":8,"mediawiki talk":9,"template":10,"template talk":11,"help":12,"help talk":13,
		"category":14,"category talk":15};
	workspace = workspace.toLowerCase();
	var id = workspaces[workspace];
	if(!id) {
		if(workspace=="" || workspace=="main")
			id = 0;
		else if(workspace.lastIndexOf("talk") != -1)
			id = 5;
		else
			id = 4;
	}
	return id;
};

MediaWikiAdaptor.prototype.openWorkspace = function(workspace,context,userParams,callback)
{
	if(!workspace)
		workspace = "";
	this.workspace = workspace;
	context = this.setContext(context,userParams,callback);
	if(workspace) {
		if(context.workspaces) {
			for(var i=0;i<context.workspaces.length;i++) {
				if(context.workspaces[i].name == workspace) {
					this.workspaceId = context.workspaces[i].id;
					break;
				}
			}
		} else {
			workspace = workspace.toLowerCase();
			this.workspaceId = MediaWikiAdaptor.getWorkspaceId(workspace);
		}
	}
	if(!this.workspaceId) {
		if(workspace=="" || workspace.toLowerCase()=="main")
			this.workspaceId = 0;
		else if(workspace.lastIndexOf("talk") != -1)
			this.workspaceId = 5;
		else
			this.workspaceId = 4;
	}
	if(context.callback) {
		context.status = true;
		window.setTimeout(function() {callback(context,userParams);},0);
	}
	return true;
};

MediaWikiAdaptor.prototype.getWorkspaceList = function(context,userParams,callback)
{
	context = this.setContext(context,userParams,callback);
	if(context.workspace) {
		context.status = true;
		context.workspaces = [{name:context.workspace,title:context.workspace}];
		if(context.callback)
			window.setTimeout(function() {callback(context,userParams);},0);
		return true;
	}
	var uriTemplate = '%0api.php?format=json&action=query&meta=siteinfo&siprop=namespaces';
	var uri = uriTemplate.format([context.host]);
	var req = MediaWikiAdaptor.doHttpGET(uri,MediaWikiAdaptor.getWorkspaceListCallback,context);
	return typeof req == 'string' ? req : true;
};


MediaWikiAdaptor.getWorkspaceListCallback = function(status,context,responseText,uri,xhr)
{
	context.status = false;
	if(status) {
		try {
			eval('var info=' + responseText);
		} catch (ex) {
			context.statusText = exceptionText(ex,MediaWikiAdaptor.serverParsingErrorMessage);
			if(context.callback)
				context.callback(context,context.userParams);
			return;
		}
		var namespaces = info.query.namespaces;
		var list = [];
		for(var i in namespaces) {
			item = {};
			item.id = namespaces[i]['id'];
			item.title = namespaces[i]['*'];
			item.name = item.title;
			list.push(item);
		}
		context.workspaces = list;
		context.status = true;
	} else {
		context.statusText = xhr.statusText;
	}
	if(context.callback)
		context.callback(context,context.userParams);
};

// get a list of the tiddlers in the current workspace
MediaWikiAdaptor.prototype.getTiddlerList = function(context,userParams,callback,filter)
{
	context = this.setContext(context,userParams,callback);
	if(!context.tiddlerLimit)
		context.tiddlerLimit = config.options.txtMediaAdaptorLimit==0 ? null : config.options.txtMediaAdaptorLimit;

	var limit = context.tiddlerLimit;
	if(filter) {
		var re = /\[(\w+)\[([ \w]+)\]\]/;
		var match = re.exec(filter);
		if(match) {
			var filterParams = MediaWikiAdaptor.normalizedTitle(match[2]);
			switch(match[1]) {
			case 'tag':
				context.responseType = 'pages';
				var uriTemplate = '%0query.php?format=json&what=category&cpnamespace=%1&cplimit=%2&cptitle=%3';
				break;
			case 'template':
				context.responseType = 'query.embeddedin';
				uriTemplate = '%0api.php?format=json&action=query&list=embeddedin&einamespace=0&eititle=Template:%3';
				if(limit)
					uriTemplate += '&eilimit=%2';
				break;
			default:
				break;
			}
		} else {
			var list = [];
			var params = filter.parseParams('anon',null,false);
			for(var i=1; i<params.length; i++) {
				var tiddler = new Tiddler(params[i].value);
				tiddler.fields.workspaceId = this.workspaceId;
				list.push(tiddler);
			}
			context.tiddlers = list;
			context.status = true;
			if(context.callback)
				window.setTimeout(function() {callback(context,userParams);},0);
			return true;
		}
	} else {
		context.responseType = 'query.allpages';
		uriTemplate = '%0api.php?format=json&action=query&list=allpages';
		if(this.workspaceId != 0)
			uriTemplate += '&apnamespace=%1';
		if(limit)
			uriTemplate += '&aplimit=%2';
	}
	var host = MediaWikiAdaptor.fullHostName(this.host);
	var uri = uriTemplate.format([host,this.workspaceId,limit,filterParams]);
	var req = MediaWikiAdaptor.doHttpGET(uri,MediaWikiAdaptor.getTiddlerListCallback,context);
	return typeof req == 'string' ? req : true;
};



MediaWikiAdaptor.getTiddlerListCallback = function(status,context,responseText,uri,xhr)
{
	context.status = false;
	context.statusText = MediaWikiAdaptor.errorInFunctionMessage.format(['getTiddlerListCallback']);
	if(status) {
		try {
			eval('var info=' + responseText);
			var pages;
			if(context.responseType == 'query.embeddedin')
				pages = info.query.embeddedin;
			else if(context.responseType == 'query.allpages')
				pages = info.query.allpages;
			else
				pages = info.pages;
			var list = [];
			for(i in pages) {
				var title = pages[i].title;
				if(title && !store.isShadowTiddler(title)) {
					tiddler = new Tiddler(title);
					tiddler.fields.workspaceId = pages[i].ns;
					list.push(tiddler);
				}
			}
			context.tiddlers = list;
		} catch (ex) {
			context.statusText = exceptionText(ex,MediaWikiAdaptor.serverParsingErrorMessage);
			if(context.callback)
				context.callback(context,context.userParams);
			return;
		}
		context.status = true;
	} else {
		context.statusText = xhr.statusText;
	}
	if(context.callback)
		context.callback(context,context.userParams);
};

MediaWikiAdaptor.prototype.generateTiddlerInfo = function(tiddler)
{
	var info = {};
	var host = this && this.host ? this.host : MediaWikiAdaptor.fullHostName(tiddler.fields['server.host']);
	if(host.match(/w\/$/)) {
		host = host.replace(/w\/$/,'');
		var uriTemplate = '%0wiki/%2';
	} else {
		uriTemplate = '%0index.php?title=%2';
	}
	info.uri = uriTemplate.format([host,this.workspace,tiddler.title]);
	return info;
};

MediaWikiAdaptor.prototype.getTiddlerRevision = function(title,revision,context,userParams,callback)
{
	context = this.setContext(context,userParams,callback);
	context.revision = revision;
	return this.getTiddlerInternal(title,context,userParams,callback);
};

MediaWikiAdaptor.prototype.getTiddler = function(title,context,userParams,callback)
{
	context = this.setContext(context,userParams,callback);
	context.title = title;
	var host = MediaWikiAdaptor.fullHostName(context.host);
	var uriTemplate = '%0api.php?format=json&action=query&prop=revisions&titles=%1&rvprop=content|timestamp|user';
	if(context.revision)
		uriTemplate += '&rvstartid=%2&rvlimit=1';
	uri = uriTemplate.format([host,MediaWikiAdaptor.normalizedTitle(context.title),context.revision]);
	context.tiddler = new Tiddler(context.title);
	context.tiddler.fields.wikiformat = 'mediawiki';
	context.tiddler.fields['server.host'] = MediaWikiAdaptor.minHostName(host);
	var req = MediaWikiAdaptor.doHttpGET(uri,MediaWikiAdaptor.getTiddlerCallback,context);
	return typeof req == 'string' ? req : true;
};


MediaWikiAdaptor.prototype.getTiddlerPostProcess = function(context)
{
	return context.tiddler;
};

MediaWikiAdaptor.getTiddlerCallback = function(status,context,responseText,uri,xhr)
{
	context.status = false;
	if(status) {
		var content = null;
		try {
			eval('var info=' + responseText);
			var page = MediaWikiAdaptor.anyChild(info.query.pages);
			var revision = MediaWikiAdaptor.anyChild(page.revisions);
			var text = revision['*'];
			context.tiddler.fields['server.page.revision'] = String(revision['revid']);
			var host = context.tiddler.fields['server.host'];
			if(host.indexOf('wikipedia')==-1) {
				context.tiddler.modified = MediaWikiAdaptor.dateFromTimestamp(revision['timestamp']);
				context.tiddler.modifier = revision['user'];
			} else {
				// content is from wikipedia
				context.tiddler.created = version.date;
				context.tiddler.modified= version.date;
				// remove links to other language articles
				text = text.replace(/\[\[[a-z\-]{2,12}:(?:.*?)\]\](?:\r?)(?:\n?)/g,'');
			}
			context.tiddler.text = text;
			var catRegExp = /\[\[(Category:[^|\]]*?)\]\]/mg;
			var tags = '';
			var delim = '';
			catRegExp.lastIndex = 0;
			var match = catRegExp.exec(text);
			while(match) {
				tags += delim;
				if(match[1].indexOf(' ')==-1)
					tags += match[1];
				else
					tags += '[[' + match[1] + ']]';
				delim = ' ';
				match = catRegExp.exec(text);
			}
			context.tiddler.tags = tags;
			context.tiddler = context.adaptor.getTiddlerPostProcess.call(context.adaptor,context);
		} catch (ex) {
			context.statusText = exceptionText(ex,MediaWikiAdaptor.serverParsingErrorMessage);
			if(context.callback)
				context.callback(context,context.userParams);
			return;
		}
		context.status = true;
	} else {
		context.statusText = xhr.statusText;
	}
	if(context.callback)
		context.callback(context,context.userParams);
};


MediaWikiAdaptor.prototype.getTiddlerRevisionList = function(title,limit,context,userParams,callback)
// get a list of the revisions for a tiddler
{
	context = this.setContext(context,userParams,callback);

	var uriTemplate = '%0api.php?format=json&action=query&prop=revisions&titles=%1&rvlimit=%2&rvprop=timestamp|user|comment';
	if(!limit)
		limit = 5;
	var host = MediaWikiAdaptor.fullHostName(context.host);
	var uri = uriTemplate.format([host,MediaWikiAdaptor.normalizedTitle(title),limit]);

	var req = MediaWikiAdaptor.doHttpGET(uri,MediaWikiAdaptor.getTiddlerRevisionListCallback,context);
	return typeof req == 'string' ? req : true;
};

MediaWikiAdaptor.getTiddlerRevisionListCallback = function(status,context,responseText,uri,xhr)
{
	context.status = false;
	if(status) {
		var content = null;
		try {
			eval('var info=' + responseText);
			var page = MediaWikiAdaptor.anyChild(info.query.pages);
			var title = page.title;
			var revisions = page.revisions;
			var list = [];
			for(var i in revisions) {
				var tiddler = new Tiddler(title);
				tiddler.modified = MediaWikiAdaptor.dateFromTimestamp(revisions[i].timestamp);
				tiddler.modifier = revisions[i].user;
//�displayMessage("tm"+tiddler.modifier);
				tiddler.fields.comment = revisions[i].comment;
				tiddler.fields['server.page.id'] = MediaWikiAdaptor.normalizedTitle(title);
				tiddler.fields['server.page.name'] = title;
				//tiddler.fields['server.page.revision'] = String(revisions[i].revid);
				list.push(tiddler);
			}
			context.revisions = list;
		} catch (ex) {
			context.statusText = exceptionText(ex,MediaWikiAdaptor.serverParsingErrorMessage);
			if(context.callback)
				context.callback(context,context.userParams);
			return;
		}
		context.status = true;
	} else {
		context.statusText = xhr.statusText;
	}
	if(context.callback)
		context.callback(context,context.userParams);
};

// MediaWikiAdaptor.prototype.putTiddler not supported
MediaWikiAdaptor.prototype.close = function()
{
	return true;
};

config.adaptors[MediaWikiAdaptor.serverType] = MediaWikiAdaptor;
} // end of 'install only once'
//}}}
These regulations implement the FDA's criteria for and authority requiring manufacturers, users and distributors to report health-related medical device failures and their corrections or removal from the market. 21 CFR 803 is an important regulation for devices that may have health-related failures
!URL
http://blogs.seapine.com/2011/07/webinar-recording-fda-design-traceability-requirements-for-device-development/?utm_source=YouTube&utm_medium=SocialMedia&utm_campaign=SocialMedia

!Description
Useful insights and guidance on traceability depth
<html>
<b>Author:</b> <input name=Author type=text font-size:16px /> 
 Rating: <select name=Rating >
 <option>*
 <option>**
 <option>***
 <option>****
 <option>*****
</select >
<input name=ReadingCompleted type=checkbox />Reading completed
<br/>
</html>
A ''Change Order'' pertains to an explicitly identified document or group of documents, and specifies the detailed revision of the document content which will fix the identified problem.
* Often, the change request results in an assignment to developers to further study the problem and develop a suitable corrective action. 
** If the change is extensive, wholesale revision of affected documents may be warranted in lieu of issuing change orders.
* Change requests and change orders should be communicated to all persons whose work might be impacted by the change
''4.2.4 Control of records''

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain [[legible|Legible]], readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements.
<svg xmlns:rdf="http://www.w3.org/1999/02/22-rdf-syntax-ns#" xmlns="http://www.w3.org/2000/svg" height="100%" width="100%" version="1.1" xmlns:cc="http://creativecommons.org/ns#" xmlns:dc="http://purl.org/dc/elements/1.1/" viewBox="0 0 40 40"><metadata><rdf:RDF><cc:Work rdf:about=""><dc:format>image/svg+xml</dc:format><dc:type rdf:resource="http://purl.org/dc/dcmitype/StillImage"/><dc:title/></cc:Work></rdf:RDF></metadata><defs><linearGradient id="lG3826" x1="7.0996" gradientUnits="userSpaceOnUse" y1="18.829" gradientTransform="matrix(1.5858347,0,0,1.8078238,1098.1851,351.13716)" x2="1.5461" y2="-0.95166"><stop stop-color="#000" offset="0"/><stop stop-color="#9c9b99" offset="1"/></linearGradient><linearGradient id="lG3828" y2="372.44" gradientUnits="userSpaceOnUse" y1="375.7" x2="1111.7" x1="1097.7"><stop style="stop-color:#ac9393;" offset="0"/><stop style="stop-color:#c8b7b7;" offset="1"/></linearGradient></defs><g transform="translate(-1080.9375,-357.3329)"><path style="stroke-width:0;stroke-miterlimit:4;fill:url(#lG3826);" d="m1080.9,357.32,39.996-0.0426-0.01,40.008c-15.507-25.519-15.36-25.95-39.988-39.965z"/><path style="stroke-dashoffset:0;stroke:#7aa3be;stroke-linecap:round;stroke-miterlimit:4;stroke-width:1.49999988;fill:#c1e6fd;" d="m1091.9,363.55c6.5716-6.4925,16.576-7.3925,23.147-0.90003,6.5717,6.4925,6.5717,17.019,0,23.511-4.4424-8.6113-12.288-15.713-23.147-22.611z"/><path style="stroke-dashoffset:0;stroke:#ce81b0;stroke-linecap:round;stroke-miterlimit:4;stroke-width:1.5;fill:#f4c4e2;" d="m1110.2,367.62c3.217,3.2168,3.217,8.4323,0,11.649-3.8194-4.2357-8.3307-8.1824-11.649-11.649,3.217-3.2168,8.4325-3.2168,11.649-0.00002z"/><path style="stroke-linejoin:bevel;stroke:#000000;stroke-linecap:round;stroke-dasharray:none;stroke-miterlimit:4;stroke-width:0.80000001;fill:url(#lG3828);" d="m1081,357.34c18.79,6.4752,32.53,16.56,39.894,39.892-11.19-17.028-14.878-19.19-27.352-14.96,6.2984-12.098,3.9371-13.19-12.542-24.932z"/></g></svg>
DMS is an abbreviation for [[Device Master Record]]
Class III Medical Devices are devices that cannot be classified as Class I or Class II because:
# General and special control do not provide reasonable assurance of their safety and effectiveness
# The devices is to be used in supporting or sustaning human life and
# The device presents a potential unreasonable risk of illness or injury.
Class III devices typically require pre market approval (PMA). PMA application content includes:
# Full reports of all information, published or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective
# Full statement of the components, properties and principles of operation for the device
# Full description of the methods and the facilities used for the manufacturing, processing, packing and installation of the device
# Reference to any existing performance standards and adequate information to show that the device fully meets each standard
# Sample of the device or the location of one or more  devices readily available for examination and testing in the instance that the device is burdensome to move;
# The labeling proposed to be used for the device;
!Examples
Examples | of Class III devices are pacemakers, replacement heart valves and total joint replacements:
<<image /static/files/FDA/Example%20Class%20III.jpg width:600>>


See also: [[Premarket approval]]
/***
|''Name''|TiddlySpaceFollowingPlugin|
|''Version''|0.7.1|
|''Description''|Provides a following macro|
|''Author''|Jon Robson|
|''Requires''|TiddlySpaceConfig TiddlySpaceTiddlerIconsPlugin ErrorHandler|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
!Usage
Tag a tiddler with "follow" to express a list of followers.
Using the {{{<<followTiddlers X>>}}}
will reveal the number of tiddlers with name X in the set of spaces the *current* user viewing your space follows.
{{{<<following jon>>}}} will list all the users following Jon.
{{{<<followers jon>>}}} will list all the followers of jon.
{{{<linkedTiddlers>>}}} will list all tiddlers across TiddlySpace linked to the current tiddler
{{{<linkedTiddlers follow:yes>>}}} will list all tiddlers across TiddlySpace that come from your list of followers
adds spaceLink view type {{{<<view server.bag spaceLink>>}}} creates a link to the space described in server.bag
{{{<<view server.bag spaceLink title>>}}} makes a link to the tiddler with title expressed in the field title in space server.bag
If no name is given eg. {{{<<following>>}}} or {{{<<follow>>}}} it will default the current user.
!StyleSheet
.followTiddlersList li {
	list-style:none;
}

.followButton {
	width: 2em;
}

.followTiddlersList li .siteIcon {
	height:48px;
	width: 48px;
}

#sidebarTabs .followers li a,
.followers .siteIcon,
.followers .siteIcon div {
	display: inline;
}

.followTiddlersList li .externalImage, .followTiddlersList li .image {
	display: inline;
}

.scanResults li {
	list-style: none;
}
!Code
***/
//{{{
(function($) {
var LIMIT_FOLLOWING = 100;

var tweb = config.extensions.tiddlyweb;
var tiddlyspace = config.extensions.tiddlyspace;
var currentSpace = tiddlyspace.currentSpace.name;

var shadows = config.shadowTiddlers;
config.annotations.ScanTemplate = "This tiddler is the default template used in the display of tiddlers founding using the tsScan macro. To access attributes use the view macro e.g. {{{<<view title text>>}}}";
shadows.ScanTemplate = "<<view modifier SiteIcon width:24 height:24 spaceLink:yes label:no>> <<view title link>>";
shadows.FollowersTemplate = "<<view server.bag SiteIcon width:24 height:24 spaceLink:yes label:no>> <<view server.bag spaceLink>>";
shadows.FollowingTemplate = "<<view title SiteIcon width:24 height:24 spaceLink:yes label:no>> <<view title spaceLink>>";
shadows.FollowTiddlersBlackList = "";
shadows.FollowTiddlersHeading = "There are tiddlers in spaces you follow using the follow tag which use the title <<view title text>>";
shadows.FollowTiddlersTemplate = ["* <<view server.space SiteIcon width:24 height:24 spaceLink:yes label:no>> ",
	"<<view server.space spaceLink title external:no>> modified by <<view modifier spaceLink>> ",
	"in the <<view server.space spaceLink>> space (<<view modified date>> @ <<view modified date 0hh:0mm>>).\n"].join("");

var name = "StyleSheetFollowing";
shadows[name] = "/*{{{*/\n%0\n/*}}}*/".
	format(store.getTiddlerText(tiddler.title + "##StyleSheet"));
store.addNotification(name, refreshStyles);

// provide support for sucking in tiddlers from the server
tiddlyspace.displayServerTiddler = function(src, title, workspace, callback) {
	var adaptor = store.getTiddlers()[0].getAdaptor();
	var localTitle = tiddlyspace.getLocalTitle(title, workspace);
	var tiddler = new Tiddler(localTitle);
	tiddler.text = "Please wait while this tiddler is retrieved...";
	tiddler.fields.doNotSave = "true";
	store.addTiddler(tiddler);
	src = story.displayTiddler(src || null, tiddler.title);
	tweb.getStatus(function(status) {
		var context = {
			host: tweb.host, // TODO: inherit from source tiddler?
			workspace: workspace,
			headers: { "X-ControlView": "false" }
		};
		var getCallback = function(context, userParams) {
			var tiddler = context.tiddler;
			tiddler.title = localTitle;
			store.addTiddler(tiddler);
			story.refreshTiddler(localTitle, null, true); // overriding existing allows updating
			if(callback) {
				callback(src, tiddler);
			}
		};
		adaptor.getTiddler(title, context, null, getCallback);
	});
};

tiddlyspace.scroller = {
	runHandler: function(title, top, bottom, height) {
		var i;
		var handlers = tiddlyspace.scroller.handlers;
		var tidEl = story.getTiddler(title);
		if(tidEl) {
			var topEl = $(tidEl).offset().top + 20;
			if(top === false || (topEl > top && topEl < bottom)) {
				var h = handlers[title];
				for(i = 0; i < h.length; i++) {
					h[i]();
				}
				tiddlyspace.scroller.clearHandlers(title);
			}
		} else {
			tiddlyspace.scroller.clearHandlers(title);
		}
	},
	clearHandlers: function(title) {
		tiddlyspace.scroller.handlers[title] = [];
	},
	registerIsVisibleEvent: function(title, handler) {
		tiddlyspace.scroller.handlers[title] = tiddlyspace.scroller.handlers[title] || [];
		tiddlyspace.scroller.handlers[title].push(handler);
	},
	init: function() {
		this.handlers = {};
		this.interval = window.setInterval(function() {
			var top = $(window).scrollTop();
			var height = $(window).height();
			var bottom = top + height;
			var title;
			for(title in tiddlyspace.scroller.handlers) {
				if(title) {
					tiddlyspace.scroller.runHandler(title, top, bottom, height);
				}
			}
		}, 2000); // every 2 seconds check scroll position
	}
};
tiddlyspace.scroller.init();

var followMacro = config.macros.followTiddlers = {
	locale: {
		followListHeader: "Here are tiddlers from spaces you follow using the follow tag which use this title.",
		noTiddlersFromFollowers: "None of the spaces you follow contain a tiddler with this name.",
		errorMessage: "There was a problem retrieving tiddlers from the server. Please try again later."
	},
	init: function() {
		followMacro.lookup = {};
	},
	followTag: "follow",
	getHosts: function(callback) {
		tweb.getStatus(function(status) {
			callback(tweb.host, tiddlyspace.getHost(status.server_host, "%0"));
		});
	},
	getBlacklist: function() {
		return store.getTiddlerText("FollowTiddlersBlackList").split("\n");
	},
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		var args = paramString.parseParams("anon")[0];
		var containingTiddler = story.findContainingTiddler(place).getAttribute('tiddler');
		var title = (args.anon && args.anon[0]) || tiddler.fields["server.title"] || tiddler.title;
		var tid = store.getTiddler(title);
		var user = params[1] || false;
		if(tid) {
			followMacro.makeButton(place, {
				url: "/search?q=title:%22" + encodeURIComponent(title) + "%22",
				containingTiddler: containingTiddler,
				blacklisted: followMacro.getBlacklist(), title: title, user: user,
				consultFollowRelationship: (args.follow &&
					args.follow[0] === 'false') ? false : true });
		}
	},
	makeButton: function(place, options) { // this is essentially the same code in TiddlySpaceFollowingPlugin
		var title = options.title;
		var blacklisted = options.blacklisted;
		var tiddler = store.getTiddler(title);
		var btn = $('<div class="followButton" />').addClass("notLoaded").appendTo(place)[0];
		if(blacklisted.contains(title)) {
			$(btn).remove();
			return;
		} else {
			var user = options.user;
			window.setTimeout(function() { // prevent multiple calls due to refresh
				tiddlyspace.scroller.registerIsVisibleEvent(options.containingTiddler, function() {
					var mkButton = function(followers, ignore) {
						if(!followers && !ignore) {
							$(btn).remove();
						} else {
							$("<a />").appendTo(btn);
							var scanOptions = { url: options.url,
								spaceField: options.spaceField || "bag", template: null, sort: "-modified",
								callback: function(tiddlers) {
									$(btn).removeClass("notLoaded");
									followMacro.constructInterface(btn, tiddlers);
								}
							};
							if(!ignore) {
								scanOptions.showBags = followMacro._getFollowerBags(followers);
							}
							scanOptions.hideBags = [tiddler.fields["server.bag"]];
							scanMacro.scan(null, scanOptions, user);
						}
					};
					if(options.consultFollowRelationship) {
						followMacro.getFollowers(mkButton);
					} else {
						mkButton([], true);
					}
				});
			}, 1000);
		}
	},
	constructInterface: function(container, tiddlers) {
		var txt = tiddlers.length;
		var className = txt > 0 ? "hasReplies" : "noReplies";
		var el = $(story.findContainingTiddler(container));
		$(container).empty().addClass(className);
		var btn = $("<a />").addClass("followedTiddlers").text(txt).
			click(function(ev) {
				followMacro.followingOnClick(ev);
			}).appendTo('<div class="followedTiddlers" />').appendTo(container)[0];
		$.data(btn, "tiddlers", tiddlers);
	},
	followingOnClick: function(ev) {
		var target = ev.target;
		var locale = followMacro.locale;
		var el = $('<div class="followTiddlersList" />')[0];
		var popup = Popup.create(target,"div");
		$(popup).addClass("taggedTiddlerList followList").click(function(ev) { // make it so only clicking on the document outside the popup removes the popup
			if(ev.target.parentNode != document) {
				ev.stopPropagation();
			}
		}).append(el);
		var tiddlers = $.data(target, "tiddlers") || [];
		scanMacro.template(el, tiddlers.slice(0,1), "FollowTiddlersHeading");
		scanMacro.template(el, tiddlers, "FollowTiddlersTemplate");
		if(tiddlers.length === 0) {
			$("<li />").text(locale.noTiddlersFromFollowers).appendTo(el);
		}
		Popup.show();
		ev.stopPropagation();
		return popup;
	},
	_getFollowerBags: function(followers) { // XXX: private or not?
		return $.map(followers, function(name, i) {
			return name != currentSpace ? "%0_public".format(name) : null;
		});
	},
	getFollowers: function(callback, username) {
		// returns a list of spaces being followed by the existing space
		var followersCallback = function(user) {
			if(!user.anon) {
				scanMacro.scan(null, { 
					url: "/search?q=bag:%0_public tag:%1 _limit:%2".format(user.name, followMacro.followTag, LIMIT_FOLLOWING),
					spaceField: "title", template: null, cache: true,
					callback: function(tiddlers) {
						var followers = [];
						for(var i = 0; i < tiddlers.length; i++) {
							followers.push(tiddlyspace.resolveSpaceName(tiddlers[i].title));
						}
						callback(followers);
					}
				});
			} else {
				callback(false);
			}
		};
		return !username ? tweb.getUserInfo(followersCallback) : followersCallback({ name: username });
	}
};

var scanMacro = config.macros.tsScan = {
	init: function () {
		this.scanned = {};
	},
	_tiddlerfy: function(jsontiddlers, options) {
		var tiddlers = [];
		var spaceField = options.spaceField || "bag"; // TODO: phase out use view types instead
		$.each(jsontiddlers, function(i, t) {
			var use = false;
			if(!options.showBags || (options.showBags && options.showBags.contains(t.bag))) {
				use = true;
			}
			if(options.hideBags && options.hideBags.contains(t.bag)) {
				use = false;
			}
			if(use) {
				var spaceName = t[spaceField];
				var tiddler = config.adaptors.tiddlyweb.toTiddler(t, tweb.host);
				tiddler.fields["server.space"] = tiddlyspace.resolveSpaceName(spaceName);
				tiddlers.push(tiddler);
			}
		});
		return tiddlers;
	},
	_scanCallback: function(place, jsontiddlers, options) {
		var locale = followersMacro.locale;
		var tiddlers = scanMacro._tiddlerfy(jsontiddlers, options);
		
		if(options.sort) {
			tiddlers = store.sortTiddlers(tiddlers, options.sort);
		}
		if(options.filter) {
			var _store = new TiddlyWiki();
			config.lastStore = _store;
			for(var i = 0; i < tiddlers.length; i++) {
				var clone = tiddlers[i];
				clone.title = tiddlyspace.getLocalTitle(clone.title, clone.fields['server.workspace']);
				_store.addTiddler(clone);
			}
			tiddlers = _store.filterTiddlers(options.filter);
		}
		if(place) {
			$(place).empty();
			var list = $("<ul />").appendTo(place)[0];
			scanMacro.template(list, tiddlers, options.template);
			if(tiddlers.length === 0) {
				$("<li />").text(options.emptyMessage || locale.noone).appendTo(list);
				$(list).addClass("emptyList");
			}
		}
		if(options.callback) {
			options.callback(tiddlers);
		}
	},
	constructSearchUrl: function(host, options) {
		if(options.url) {
			return options.url;
		}
		var inputs = options.searchValues;
		var tag = options.tag;
		var searchField = options.searchField || "title";
		var searchQuery = [];
		for(var i = 0; i < inputs.length; i++) {
			searchQuery.push('%0:"%1"'.format(searchField, inputs[i]));
		}
		var query = searchQuery.join(" OR ");
		query = tag ? "(%0) AND tag:%1".format(query, tag) : query;
		query = options.query ? "%0;%1;".format(query, options.query) : query;
		query = options.fat ? "%0&fat=1".format(query) : query;
		return '%0/search?q=%1'.format(host, query);
	},
	scan: function(place, options) { // TODO: make use of list macro with url filter
		var locale = followersMacro.locale;
		options.template = options.template ? options.template : "ScanTemplate";
		followMacro.getHosts(function(host, tsHost) {
			$(place).text(followersMacro.locale.pleaseWait);
			options = options ? options: {};
			var url = scanMacro.constructSearchUrl(host, options);
			if(options.cache && scanMacro.scanned[url]) {
				var tiddlers = scanMacro.scanned[url].tiddlers;
				var run = function(tiddlers) {
					scanMacro._scanCallback(place, tiddlers, options);
				};
				if(tiddlers) {
					run(tiddlers);
				} else {
					scanMacro.scanned[url].callbacks.push(run);
				}
			} else {
				var callback = function(tiddlers) {
					scanMacro._scanCallback(place, tiddlers, options);
				};
				if(scanMacro.scanned[url] && scanMacro.scanned[url].callbacks) {
					scanMacro.scanned[url].callbacks.push(callback);
				} else {
					scanMacro.scanned[url] = {
						callbacks: [callback]
					};
				}
				ajaxReq({
					url: url,
					dataType: "json",
					success: function(tiddlers) {
						scanMacro.scanned[url].tiddlers = tiddlers;
						var callbacks = scanMacro.scanned[url].callbacks;
						while(callbacks.length > 0) {
							callbacks.pop()(tiddlers);
						}
					},
					error: function(xhr) {
						$(place).empty();
						$("<span />").addClass("annotation error").text(locale.error.format(xhr.status)).appendTo(place);
					}
				});
			}
		});
	},
	template: function(place, tiddlers, template) { // TODO: make use of list macro.
		for(var i = 0; i < tiddlers.length; i++) {
			var tiddler = tiddlers[i];
			var item = $('<li class="spaceName" />').appendTo(place)[0];
			var spaceName = tiddler.fields["server.space"] || "";
			var templateText = store.getTiddlerText(template).replace(/\$1/mg, spaceName);
			wikify(templateText, item, null, tiddler);
		}
	},
	getOptions: function(paramString, tiddler) {
		var args = paramString.parseParams("name", null, true, false, true)[0];
		var options = { query: false, sort: false, tag: false, template: false, showBags: args.show || false,
			hideBags: args.hide || false, filter: false, spaceField: "bag", searchField: "title", fat: false,
			emptyMessage: false };
		for(var name in args) {
			if(name != "name") {
				if(name == "fat") {
					options[name] = true;
				} else {
					options[name] = args[name][0];
				}
			}
		}
		// if user has set searchField to modifier, then use the modifiers value if available otherwise use searchValues.
		var searchField = options.searchField;
		var searchValues = args[searchField] ? args[searchField] : args.searchValues;
		// if neither of those were used use the first parameter
		var defaultValues = tiddler ? [ tiddler.title ] : [];
		options.searchValues = searchValues ? searchValues : ( args.name ? [args.name[0]] : defaultValues);
		return options;
	},
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		var container = $("<div />").addClass("scanResults resultsArea").appendTo(place)[0];
		var options = scanMacro.getOptions(paramString, tiddler);
		scanMacro.scan(container, options);
	}
};

var followersMacro = config.macros.followers = {
	locale: {
		loggedOut: "Please login to see the list of followers",
		noSupport: "We were unable to retrieve followers as your browser does not support following.",
		pleaseWait: "Please wait while we look this up...",
		error: "Error %0 occurred whilst retrieving data from server",
		noone: "None."
	},
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		var locale = followersMacro.locale;
		var args = paramString.parseParams("name", null, true, false, true)[0];
		var username = args.name ? args.name[0] : false;
		var container = $('<div class="followers" />').text(locale.pleaseWait).
			appendTo(place)[0];
		var followersCallback = function(user) {
			if(user.anon) {
				$("<span />").text(locale.loggedOut).appendTo(container);
			} else {
				var options = scanMacro.getOptions(paramString);
				$.extend(options, {
					url: "/search?q=title:@%0 OR title:%0 tag:%1 _limit:%2".
						format(user.name, followMacro.followTag, LIMIT_FOLLOWING),
					spaceField: "bag",
					template: options.template ? options.template : "FollowersTemplate"
				});
				scanMacro.scan(container, options);
			}
		};
		return !username ? followersCallback({ name: currentSpace }) : followersCallback({ name: username });
	}
};

var followingMacro = config.macros.following = {
	locale: {
		pleaseWait: followersMacro.locale.pleaseWait,
		loggedOut: "Please login to see who you are following",
		noSupport: followersMacro.locale.noSupport,
		error: followersMacro.locale.error,
		noone: followersMacro.locale.noone
	},
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		var locale = followingMacro.locale;
		var args = paramString.parseParams("name", null, true, false, true)[0];
		var fat = args.fat ? true : false;
		var username = args.name ? args.name[0] : false;
		var container = $('<div class="following" />').text(locale.pleaseWait).
			appendTo(place)[0];
		var followingCallback = function(user) {
			if(user.anon) {
				$("<span />").text(locale.loggedOut).appendTo(container);
			} else {
				var options = scanMacro.getOptions(paramString);
				$.extend(options, {
					url: "/search?q=bag:%0_public tag:%1 _limit:%2".format(user.name, followMacro.followTag, LIMIT_FOLLOWING),
					spaceField: "title",
					template: options.template ? options.template : "FollowingTemplate"
				});
				scanMacro.scan(container, options);
			}
		};
		return !username ? followingCallback({ name: currentSpace }) : followingCallback({ name: username });
	}
};

var linkedMacro = config.macros.linkedTiddlers = {
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		var args = paramString.parseParams("anon")[0];
		var title = params[0] || tiddler.fields["server.title"] || tiddler.title;
		var tid = store.getTiddler(title);
		var containingTiddler = story.findContainingTiddler(place).getAttribute('tiddler');
		if(tid) {
			followMacro.makeButton(place, {
				spaceField: "recipe",
				url: "/bags/%0/tiddlers/%1/backlinks".format(tid.fields['server.bag'],
					encodeURIComponent(tid.title)),
				blacklisted: followMacro.getBlacklist(),
				title: title,
				containingTiddler: containingTiddler,
				user: params[1] || false,
				consultFollowRelationship: args.follow ? true : false });
		}
	}
};

if(config.options.chkFollowTiddlersIsLinkedTiddlers) {
	merge(config.macros.followTiddlers, config.macros.linkedTiddlers);
	config.shadowTiddlers.FollowTiddlersHeading = "These are the other tiddlers that link to this tiddler.";
}

})(jQuery);
//}}}
The organization shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch (see 4.2.4). Sterilization records shall be traceable to each production batch of medical devices (see 7.5.1.1).
//(6) Override capability//
If the fluoroscopic x-ray field size is adjusted automatically as the [[SID]] or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure.

If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:
!!For X-ray Field Limitation System Failure
A ''Quality System'' means the organizational structure, responsibilities, procedures, processes and resources for implementing quality management.

Quality System includes all activities previously referred to by FDA as 'quality assurance''.
We use _ to get the 'bottom' parts of summations, products, and limits, as well as the subscripts of logarithms. We use ^ to get the 'top' parts of sums and products. (Integration symbols work the same way, as you'll see in the calculus section.) Click here for a few other commands which take 'bottom' parts.

|Symbol|Command|h
|$\large \textstyle \sum_{i=1}^{\infty}\frac{1}{i}$|\\sum_{i=1}^{\\infty}\frac{1}{i}|
|$\large \textstyle \prod_{n=1}^5\frac{n}{n-1}$|\\prod_{n=1}^5\\frac{n}{n-1}|
|$\large \textstyle \lim_{x\to\infty}\frac{1}{x}$|\\lim_{x\to\infty}\\frac{1}{x}|
|$\large \textstyle \log_n n^2$|\\log_n n^2|

Some of these are prettier in display mode:
|Symbol|Command|h
|$\large \displaystyle \sum_{i=1}^{\infty}\frac{1}{i}$|\\displaystyle \\sum_{i=1}^{\\infty}\\frac{1}{i}|
|$\large \displaystyle \prod_{n=1}^5\frac{n}{n-1}$|\\displaystyle \\prod_{n=1}^5\\frac{n}{n-1}|
|$\large \displaystyle \lim_{x\to\infty}\frac{1}{x}$|\\displaystyle \\lim_{x\\to\\infty}\\frac{1}{x}|

Note that we can use sums, products, and logarithms without _ or ^ modifiers.
|Symbol|Command|h
|$\large \displaystyle \sum\frac{1}{i}$|\displaystyle\sum\frac{1}{i}|
|$\large \displaystyle \frac{n}{n-1}$|\displaystyle\frac{n}{n-1}|
|$\large \displaystyle \textstyle \log n^2$|\log n^2|
|$\large \displaystyle \textstyle \ln e$|\ln e|
These regulations implement the FDA's criteria for and authority over the use of electronic records and electronic and handwritten signatures executed in electronics recordds. FDA requires such uses to be trustworthy, reliable and generally equivaluent to paper records and handwritten signatures. Any computer system, both hardware and software controls and documentation must be readily available for FDA inspection.
<<image /static/files/FDA/CFR%2011%20Electronic%20Signature.jpg width:300>>
<svg xmlns="http://www.w3.org/2000/svg" xmlns:xl="http://www.w3.org/1999/xlink" version="1.1" viewBox="434 218 68 68"
width="30" height="30">
<g stroke="none" stroke-opacity="1" stroke-dasharray="none" fill="none" fill-opacity="1">
	<g>
		<path d="M 478.39694 232.53705 L 478.39694 232.53705 
		C 477.1145 231.85132 475.77875 231.30147 474.41058 230.88734 L 474.41058 218.24994 L 461.58942 218.24994 
		L 461.58942 230.88734 C 460.22125 231.30147 458.8855 231.85132 457.60306 232.53705 L 448.66824 223.60214 
		L 439.6022 232.66814 L 448.53717 241.60304 C 447.8515 242.8854 447.30157 244.22116 446.88745 245.58936 
		L 434.25 245.58936 L 434.25 258.41052 L 446.88745 258.41052 
		C 447.30157 259.77869 447.8515 261.11447 448.53717 262.39688 L 439.6022 271.33173 L 448.66824 280.3978 
		L 457.60306 271.46283 C 458.8855 272.14862 460.22125 272.69846 461.58942 273.11252 L 461.58942 285.74988 
		L 474.41058 285.74988 L 474.41058 273.11252 C 475.77875 272.69846 477.1145 272.14862 478.39694 271.46283 
		L 487.33176 280.3978 L 496.39767 271.33173 L 487.46286 262.39688 
		C 488.14853 261.11447 488.69836 259.77869 489.11255 258.41052 L 501.74988 258.41052 L 501.74988 245.58936 
		L 489.11255 245.58936 C 488.69836 244.22116 488.14853 242.8854 487.46286 241.60304 L 496.39767 232.66814 
		L 487.33176 223.60214 Z M 475.3328 244.66714 C 479.3825 248.71698 479.3825 255.2829 475.3328 259.33273 
		C 471.28296 263.3826 464.71704 263.3826 460.66724 259.33273 
		C 456.61737 255.2829 456.61737 248.71698 460.66724 244.66714 
		C 464.71704 240.61734 471.28296 240.61734 475.3328 244.66714" fill="#111"
		class="glyph"/>
	</g>
</g>
</svg>
7.2.1 Determination of requirements related to the product

The organization shall determine:
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.
//(j) Display of last-image-hold (LIH)//
Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.
* (1) For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure.
* (2) For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the techniques factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.
* (3) Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.
* (4) The predetermined or selectable options for producing the LIH radiograph shall be described in the information required by [[1020.30(h)|CFR 1020.32 Fluoroscopic equipment (h)(2) Fluoroscopic irradiation time, display, and signal after June 10 2006]]. The information shall include a description of any technique factors applicable for the selected option and the impact of the selectable options on image characteristics and the magnitude of radiation emissions.
Readable (Good Documentation Practices)
''4.2.1 General''

The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes,
e) records required by this International Standard (see 4.2.4), and
f) any other documentation specified by national or regional regulations.

Where this International Standard specifies that a requirement, procedure, activity or special arrangement be “documented”, it shall, in addition, be implemented and maintained.

For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing.

NOTE 1 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of the organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.

NOTE 2 The documentation can be in any form or type of medium.
{{{
config.macros.AudioFragment = {
  handler: function (place, macroName, params, wikifier, paramString, tiddler)
  {
     var url;

     if (params[0] != null)
     {
           url = params[0];
     }

//     resultString = "<html>";
//     resultString += '<embed type="application/x-shockwave-flash" src="http://www.odeo.com/flash/audio_player_standard_gray.swf'
//     resultString += ' width="400" height="27" allowscriptaccess="always" quality="best" bgcolor="#ffffff" wmode="transparent"  flashvars="external_url='
//     resultString += url + '"';
//     resultString += ' />'
//     resultString += '</html>';


     resultString = "<html>";
     resultString += '<embed type="application/x-shockwave-flash" src="/static/files/audio-player.swf?audioUrl='
     resultString += url + '"';
     resultString += ' width="400" height="27" allowscriptaccess="never" quality="best" bgcolor="#ffffff" wmode="window" flashvars="playerMode=embedded" />'
     resultString += '</html>';

     wikify(resultString,place);
   }
 }
}}}
This space is my summary of the FDA regulations for personal search and reference.
<<closeAll>><<permaview>><<newTiddler>>
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
/***
|''Name:''|DiffFormatterPlugin|
|''Description:''|Extension of TiddlyWiki syntax to support Diff text formatting|
|''Author:''|Martin Budden (mjbudden (at) gmail (dot) com)|
|''Source:''|http://www.martinswiki.com/#DiffFormatterPlugin |
|''CodeRepository:''|http://svn.tiddlywiki.org/Trunk/contributors/MartinBudden/formatters/DiffFormatterPlugin.js |
|''Version:''|0.0.3|
|''Date:''|Sep 11, 2009|
|''Comments:''|Please make comments at http://groups.google.co.uk/group/TiddlyWikiDev |
|''License:''|[[Creative Commons Attribution-ShareAlike 2.5 License|http://creativecommons.org/licenses/by-sa/2.5/]] |
|''~CoreVersion:''|2.1.0|

This is an early release of the DiffFormatterPlugin, which extends the TiddlyWiki syntax to support Diff
text formatting.

The Diff formatter is different from the other formatters in that Tiddlers are not required to be
tagged: instead the Diff format adds formatting that augments TiddlyWiki's format.

The Diff formatter adds the following:
# ^+ for added
# ^- for removed
# ^"""@@ """, """--- """ and """+++ """ for special markers

Please report any defects you find at http://groups.google.co.uk/group/TiddlyWikiDev
!StyleSheet
.viewer .removed { background: #fdd; }
.viewer .added { background: #dfd; }
!Code
***/
//{{{
// Ensure that the DiffFormatterPlugin is only installed once.
if(!version.extensions.DiffFormatterPlugin) {
version.extensions.DiffFormatterPlugin = {installed:true};

if(version.major < 2 || (version.major == 2 && version.minor < 1)) {
	alertAndThrow('DiffFormatterPlugin requires TiddlyWiki 2.1 or later.');
}

diffFormatter = {}; // 'namespace' for local functions

diffFormatter.init = function() {
	var stylesheet = store.getTiddlerText(tiddler.title + "##StyleSheet");
	if(stylesheet) { // check necessary because it happens more than once for some reason
		config.shadowTiddlers["StyleSheetDiffFormatter"] = stylesheet;
		store.addNotification("StyleSheetDiffFormatter", refreshStyles);
	}
};

diffFormatter.added = {
	name: 'diffAdded',
	match: '^\\+',
	termRegExp: /(\n)/mg,
	handler: function(w)
	{
		var e = createTiddlyElement(w.output,'span',null,'added');
		w.subWikifyTerm(e,this.termRegExp);
		createTiddlyElement(w.output,'br');
	}
};

diffFormatter.removed = {
	name: 'diffRemoved',
	match: '^-',
	termRegExp: /(\n)/mg,
	handler: function(w)
	{
		var e = createTiddlyElement(w.output,'span',null,'removed');
		w.subWikifyTerm(e,this.termRegExp);
		createTiddlyElement(w.output,'br');
	}
};

diffFormatter.charDiff = {
	name: 'diffChars',
	match: '^(?:@@|[+-]{3}) ',
	lookaheadRegExp: /^(?:@@|[+-]{3}) .*\n/mg,
	handler: function(w)
	{
		this.lookaheadRegExp.lastIndex = w.matchStart;
		var lookaheadMatch = this.lookaheadRegExp.exec(w.source);
		if(lookaheadMatch && lookaheadMatch.index == w.matchStart) {
			w.nextMatch = this.lookaheadRegExp.lastIndex;
		}
	}
};

// add new formatters
diffFormatter.init();
config.formatters.push(diffFormatter.added);
config.formatters.push(diffFormatter.removed);

diffFormatter.replaceFormatter = function()
{
	for(var i=0; i<config.formatters.length; i++) {
		if(config.formatters[i].name == 'characterFormat') {
			config.formatters.splice(i,0,diffFormatter.charDiff);
			break;
		}
	}
};
diffFormatter.replaceFormatter();

}// end of 'install only once'
//}}}
These regulations implement the FDA's responsibilities for and authority to control electronics products. Manufacturers of applicable medical products are required to certify that the product conforms to all applicable standards.
The CFR regulations described with respect to Management Responsibility are:
<<forEachTiddler
    where
        'tiddler.tags.contains("CFR 21-820.20")'
    sortBy 
         'tiddler.title.toUpperCase()'
   write
         '"* [["+tiddler.title+"]]" + "\n"'

>>
The FDA preannouncement call will request a copy of:
* the firm's [[quality policy system procedure|CFR 21-820.20e - Quality System Procedures]]
* The [[Quality Manual]]
* The [[Quality Plan]]

!FDA Inspection
* The investigators will review the written [[Quality Policy]] and will assess it to ensure that it defines tthe firm's overall quality intention
* The investigators will determine whether the firms [[Management with executive responsibility]] ensures that the quality policy is understood at all levels of the organization.
* Investigators will determine whethere management reviews and quality audits are being conducted in correspondence with written procedures.
* They will evaluate the firms [[Quality Plan]] to determine if the firm's quality practices, resources and activities are relevant and specific to the regulated medical devices that are manufactured.

Each manufacturer must prepare and implement all activities the applicable requirements of the [[Quality System Regulation]] that are necceary to assure that the device, the design process, the manufacturing process and all related activities conform to approved specifications.

!Management Representative
The FDA expects that a firm has a documented ''management representative'' that has review and approval responsibility for appropriate milestones in the quality system. Investigators will assess a firms:
* Organizational Chart
* Quality Manual
* [[Design Control Activities]]
* Complaint Procedures
* Medical Device reporting procedures
* [[Quality Audit Procedure]] and schedule
* Quality reaudits, audit reports and corrective and preventive actions.

The management representatives 'fingerprints' should be all over these activities.

<<tiddler [[CFR 21-820.20 - Management Control Flowchart]]>>
/***
https://raw.github.com/tiddlyweb/chrjs/master/main.js
***/
//{{{
// TiddlyWeb adaptor
// v0.14.3

/*jslint vars: true, unparam: true, nomen: true, white: true */
/*global jQuery */

var tiddlyweb = (function($) {

"use strict";

var tw = {
	routes: {
		// host is the TiddlyWeb instance's URI (including server_prefix)
		// placeholders "_type" & "name" refer to the respective bag/recipe
		root     : "{host}/",
		bags     : "{host}/bags",
		bag      : "{host}/bags/{name}",
		recipes  : "{host}/recipes",
		recipe   : "{host}/recipes/{name}",
		tiddlers : "{host}/{_type}s/{name}/tiddlers",
		tiddler  : "{host}/{_type}s/{name}/tiddlers/{title}",
		revisions: "{host}/{_type}s/{name}/tiddlers/{title}/revisions",
		revision : "{host}/{_type}s/{name}/tiddlers/{title}/revisions/{revision}",
		search   : "{host}/search?q={query}"
	}
};

var convertTimestamp, supplant;

// host (optional) is the URI of the originating TiddlyWeb instance
tw.Resource = function(type, host) {
	if(arguments.length) { // initialization
		this._type = type;
		if(host !== false) {
			this.host = host !== undefined ? host.replace(/\/$/, "") : null;
		}
	}
};
$.extend(tw.Resource.prototype, {
	// retrieves resource from server
	// callback is passed resource, status, XHR (cf. jQuery.ajax success)
	// errback is passed XHR, error, exception, resource (cf. jQuery.ajax error)
	// filters is an optional filter string (e.g. "select=tag:foo;limit=5")
	get: function(callback, errback, filters) {
		var uri = this.route();
		if(filters) {
			var separator = uri.indexOf("?") === -1 ? "?" : ";";
			uri += separator + filters;
		}
		var self = this;
		return $.ajax({
			url: uri,
			type: "GET",
			dataType: "json",
			success: function(data, status, xhr) {
				var resource = self.parse(data);
				resource.etag = xhr.getResponseHeader("Etag");
				callback(resource, status, xhr);
			},
			error: function(xhr, error, exc) {
				errback(xhr, error, exc, self);
			}
		});
	},
	// sends resource to server
	// callback is passed data, status, XHR (cf. jQuery.ajax success)
	// errback is passed XHR, error, exception, resource (cf. jQuery.ajax error)
	put: function(callback, errback) {
		var self = this;
		var options = {
			url: this.route(),
			type: "PUT",
			contentType: "application/json",
			data: JSON.stringify(this.baseData()),
			success: function(data, status, xhr) {
				callback(self, status, xhr);
			},
			error: function(xhr, error, exc) {
				errback(xhr, error, exc, self);
			}
		};
		if(this.ajaxSetup) {
			this.ajaxSetup(options);
		}
		return $.ajax(options);
	},
	// deletes resource on server
	// callback is passed data, status, XHR (cf. jQuery.ajax success)
	// errback is passed XHR, error, exception, resource (cf. jQuery.ajax error)
	"delete": function(callback, errback) {
		var self = this;
		var options = {
			url: this.route(),
			type: "DELETE",
			success: function(data, status, xhr) {
				callback(self, status, xhr);
			},
			error: function(xhr, error, exc) {
				errback(xhr, error, exc, self);
			}
		};
		if(this.ajaxSetup) {
			this.ajaxSetup(options);
		}
		return $.ajax(options);
	},
	// returns an object carrying only the essential information of the resource
	baseData: function() {
		var data = {},
			self = this;
		$.each(this.data, function(i, item) {
			var value = self[item];
			if(value !== undefined) {
				data[item] = value;
			}
		});
		return data;
	},
	// returns corresponding instance from a raw object (if applicable)
	parse: function(data) {
		return data;
	},
	// list of accepted keys in serialization
	data: [],
	// returns resource's URI
	route: function() {
		return supplant(tw.routes[this._type], this);
	}
});

var Container = function(type, name, host) {
	if(arguments.length) { // initialization
		tw.Resource.apply(this, [type, host]);
		this.name = name;
		this.desc = "";
		this.policy = new tw.Policy({});
	}
};
Container.prototype = new tw.Resource();
$.extend(Container.prototype, {
	tiddlers: function() {
		return new tw.TiddlerCollection(this);
	},
	parse: function(data) {
		var type = tw._capitalize(this._type),
			container = new tw[type](this.name, this.host);
		data.policy = new tw.Policy(data.policy);
		return $.extend(container, data);
	},
	data: ["desc", "policy"]
});

// attribs is an object whose members are merged into the instance (e.g. query)
tw.Collection = function(type, host, attribs) {
	if(arguments.length) { // initialization
		tw.Resource.apply(this, [type, host]);
		$.extend(this, attribs);
	}
};
tw.Collection.prototype = new tw.Resource();

tw.TiddlerCollection = function(container, tiddler) {
	if(arguments.length) { // initialization
		tw.Collection.apply(this, [tiddler ? "revisions" : "tiddlers"]);
		this.container = container || null;
		this.tiddler = tiddler || null;
	}
};
tw.TiddlerCollection.prototype = new tw.Collection();
$.extend(tw.TiddlerCollection.prototype, {
	parse: function(data) {
		var container = this.container;
		return $.map(data, function(item, i) {
			var tiddler = new tw.Tiddler(item.title, container),
				bag = item.bag;
			tiddler = tw.Tiddler.prototype.parse.apply(tiddler, [item]);
			if(!tiddler.bag && bag) { // XXX: bag always present!?
				tiddler.bag = new tw.Bag(bag, container.host);
			}
			if(!tiddler.recipe && item.recipe) {
				tiddler.recipe = new tw.Recipe(item.recipe, container.host);
			}
			delete item.recipe;
			return $.extend(tiddler, item);
		});
	},
	route: function() {
		var params = this.container;
		if(this.tiddler) {
			var container = this.tiddler.bag || this.tiddler.recipe;
			params = {
				_type: container._type,
				host: container.host,
				name: container.name,
				title: this.tiddler.title
			};
		}
		return supplant(tw.routes[this._type], params);
	}
});

tw.Search = function(query, host) {
	tw.Collection.apply(this, ["search", host]);
	this.query = query;
};
tw.Search.prototype = new tw.Collection();
$.extend(tw.Search.prototype, {
	parse: function(data) {
		this.container = { // XXX: hacky
			_type: "bag",
			host: this.host
		};
		var tiddlers = tw.TiddlerCollection.prototype.parse.apply(this, arguments);
		delete this.container;
		return tiddlers;
	}
});

// title is the name of the tiddler
// container (optional) is an instance of either Bag or Recipe
// optionally accepts a single object representing tiddler attributes
tw.Tiddler = function(title, container) {
	tw.Resource.apply(this, ["tiddler", false]);
	this.title = title;
	this.bag = container && container._type === "bag" ? container : null;
	this.recipe = container && container._type === "recipe" ? container : null;
	var self = this;
	$.each(this.data, function(i, item) {
		self[item] = undefined; // exposes list of standard attributes for inspectability
	});
	if(title && title.title) { // title is an object of tiddler attributes
		$.extend(this, title);
	}
};
tw.Tiddler.prototype = new tw.Resource();
$.extend(tw.Tiddler.prototype, {
	revisions: function() {
		return new tw.TiddlerCollection(this.bag || this.recipe, this);
	},
	route: function() {
		var container = this.bag || this.recipe;
		var params = $.extend({}, this, {
			host: container ? container.host : null,
			_type: this.bag ? "bag" : (this.recipe ? "recipe" : null),
			name: container ? container.name : null
		});
		return supplant(tw.routes[this._type], params);
	},
	parse: function(data) {
		var tiddler = new tw.Tiddler(this.title),
			container = this.bag || this.recipe;
		if(data.bag) {
			tiddler.bag = new tw.Bag(data.bag, container.host);
			delete data.bag;
		}
		delete data.recipe;
		tiddler.created = data.created ? convertTimestamp(data.created) : new Date();
		delete data.created;
		tiddler.modified = data.modified ? convertTimestamp(data.modified) : new Date();
		delete data.modified;
		if(this.recipe) {
			tiddler.recipe = this.recipe;
		}
		return $.extend(tiddler, data);
	},
	data: ["created", "creator", "modifier", "modified", "tags", "type", "text",
			"fields"],
	ajaxSetup: function(options) {
		var self = this;
		if(this.etag && (options.type === "PUT" || options.type === "DELETE")) {
			options.beforeSend = function(xhr) {
				xhr.setRequestHeader("If-Match", self.etag);
			};
		}
		if(options.type === "PUT") {
			var callback = options.success;
			options.success = function(data, status, xhr) {
				var loc = xhr.getResponseHeader("Location"),
					etag = xhr.getResponseHeader("Etag");
				if(loc && etag) {
					self.etag = etag;
					if(!self.bag) {
						var bag = loc.split("/bags/").pop().split("/")[0];
						self.bag = new tw.Bag(bag, self.recipe.host);
					}
					callback(self, status, xhr);
				} else { // IE
					self.get(callback, options.error);
				}
			};
		}
	}
});

tw.Revision = function(id, tiddler) {
	var container = tiddler.bag || tiddler.recipe;
	tw.Tiddler.apply(this, [tiddler.title, container]);
	this._type = "revision";
	this.revision = id;
};
tw.Revision.prototype = new tw.Tiddler();
$.extend(tw.Revision.prototype, {
	revisions: false,
	data: false,
	put: false,
	"delete": false
});

tw.Bag = function(name, host) {
	Container.apply(this, ["bag", name, host]);
};
tw.Bag.prototype = new Container();

tw.Recipe = function(name, host) {
	Container.apply(this, ["recipe", name, host]);
	this.recipe = [];
};
tw.Recipe.prototype = new Container();
$.extend(tw.Recipe.prototype, {
	data: ["recipe"].concat(Container.prototype.data)
});

tw.Policy = function(constraints) { // TODO: validation?
	var self = this;
	$.each(this.constraints, function(i, item) {
		self[item] = constraints[item];
	});
};
tw.Policy.prototype.constraints = ["read", "write", "create", "delete",
	"manage", "accept", "owner"];

/*
 * utilities
 */

tw._capitalize = function(str) {
	return str.charAt(0).toUpperCase() + str.slice(1);
};

// convert YYYYMMDDhhmmss timestamp to Date instance
convertTimestamp = function(t) {
	if (t.match(/^\d{12,17}$/)) {
		return new Date(Date.UTC(
			parseInt(t.substr(0, 4), 10),
			parseInt(t.substr(4, 2), 10) - 1,
			parseInt(t.substr(6, 2), 10),
			parseInt(t.substr(8, 2), 10),
			parseInt(t.substr(10, 2), 10),
			parseInt(t.substr(12, 2) || "0", 10),
			parseInt(t.substr(14, 3) || "0", 10)
		));
	} else {
		return new Date(Date.parse(t));
	}
};

// adapted from Crockford (http://javascript.crockford.com/remedial.html)
supplant = function(str, obj) {
	return str.replace(/{([^{}]*)}/g, function (a, b) {
		var r = obj[b];
		r = typeof r === "string" || typeof r === "number" ? r : a;
		return $.inArray(b, ["host", "query"]) !== -1 ? r : encodeURIComponent(r); // XXX: special-casing
	});
};

return tw;

}(jQuery));
//}}}
''7.2.3 Customer communication''

The organization shall determine and implement effective arrangements for communicating with customers in relation to

a) product information,
b) enquiries, contracts or order handling, including amendments,
c) customer feedback, including customer complaints (see 8.2.1), and
d) advisory notices (see 8.5.1).
/***
|''Name''|BinaryUploadPlugin|
|''Version''|0.3.16|
|''Author''|Ben Gillies and Jon Robson|
|''Type''|plugin|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/BinaryUploadPlugin.js|
|''Description''|Upload a binary file to TiddlyWeb|
|''CoreVersion''|2.6.1|
|''Requires''|TiddlySpaceConfig TiddlyWebConfig|
!Usage
{{{
<<binaryUpload bag:<name> edit:tags edit:title tags:<default tags> title:<title> >>
}}}
* {{{bag:<name>}}}: optional; if left out, the file will be saved to the current workspace
* {{{edit:tags}}}: specifies that you want to tag the file being uploaded
* {{{edit:title}}}: specifies that you want to set the title to something other than the filename
* {{{tags:<default tags>}}}: specifies a default set of tags to apply to the file (requires {{{edit:tags}}} to be set)
* {{{title:<title>}}}: predefines the title of the binary tiddler
!Requires
TiddlyWeb
tiddlywebplugins.form
!Code
***/
//{{{
(function($) {

var tiddlyspace = config.extensions.tiddlyspace;

var macro = config.macros.binaryUpload = {
	locale: {
		titleDefaultValue: "Please enter a title...",
		tagsDefaultValue: "Please enter some tags...",
		titlePrefix: "title: ",
		tagsPrefix: "tags: ",
		loadSuccess: 'Tiddler %0 successfully uploaded',
		loadError: "An error occurred when uploading the tiddler %0",
		uploadInProgress: "Please wait while the file is uploaded...",
		membersOnly: "Only members can upload."
	},
	renderInputFields: function(container, options) {
		var locale = macro.locale;
		var editableFields = options.edit;
		var includeFields = {
			tags:  editableFields && editableFields.contains("tags") ? true : false,
			title: editableFields && editableFields.contains("title") ? true : false
		};
		var fields = ["title", "tags"];
		for(var i = 0; i < fields.length; i++) {
			var fieldName = fields[i];
			var userDefault = options[fieldName];
			var defaultValue = userDefault ? userDefault[0] : false;
			if(includeFields[fieldName] || defaultValue) {
				var localeDefault = locale["%0DefaultValue".format(fieldName)];
				var className = defaultValue ? "userInput" : "userInput notEdited";
				var inputEl;
				var val = defaultValue || localeDefault || "";
				var iContainer = $("<div />").addClass("binaryUpload%0".format(fieldName)).
					appendTo(container);
				if(defaultValue && !includeFields[fieldName]) {
					var label = locale["%0Prefix".format(fieldName)];
					$("<span />").text(label).appendTo(iContainer);
					$("<span />").addClass("disabledInput").text(val).appendTo(iContainer);
					inputEl = $("<input />").attr("type", "hidden");
				} else {
					inputEl = $("<input />").attr("type", "text");
				}
				inputEl.attr("name", fieldName).
					addClass("%0Edit".format(fieldName)).
					val(val).addClass(className).appendTo(iContainer);
			}
		}
	},
	getTiddlerName: function(fileName) {
		var fStart = fileName.lastIndexOf("\\");
		var fStart2 = fileName.lastIndexOf("/");
		fStart = fStart < fStart2 ? fStart2 : fStart;
		fileName = fileName.substr(fStart+1);
		return fileName;
	},
	errorHandler: function(fileName) {
		displayMessage("upload of file %0 failed".format(fileName));
	},
	uploadFile: function(place, baseURL, workspace, options) {
		var pleaseWait = $(".uploadProgress", place);
		var iframeName = options.target;
		var form = $("form", place);
		var existingVal = $("input[name=title]", form).val();
		var fileName = existingVal || $('input:file', form).val();
		if(!fileName) {
			return false; // the user hasn't selected a file yet
		}
		fileName = macro.getTiddlerName(fileName);
		$("input[name=title]", place).val(fileName);
		// we need to go somewhere afterwards to ensure the onload event triggers
		var redirectTo = "/%0/tiddlers.txt?select=title:%1".
			format(workspace, fileName);
		var token = tiddlyspace ? tiddlyspace.getCSRFToken() : "";
		var action = "%0?csrf_token=%1&redirect=%2"
			.format(baseURL, token, redirectTo);
		form[0].action = action; // dont use jquery to work with ie
		form[0].target = iframeName;
		// do not refactor following line... won't work in IE6 otherwise
		$(place).append($('<iframe name="' + iframeName + '" id="' + iframeName + '"/>').css('display','none'));
		macro.iFrameLoader(iframeName, function() {
			var content = document.getElementById(iframeName).contentWindow.document.documentElement;
			if($(content).text().indexOf(fileName) > -1) {
				options.callback(place, fileName, workspace, baseURL);
			} else {
				macro.errorHandler(fileName);
			}
			form.show(1000);
			pleaseWait.hide(1000);
		});
		form.hide(1000);
		pleaseWait.show(1000);
		return true;
	},
	createUploadForm: function(place, options) {
		var locale = macro.locale;
		if(readOnly) {
			$('<div class="annotation" />').text(locale.membersOnly).
				appendTo(place);
			return;
		}
		var bag = options.bag;
		options.callback = options.callback ? options.callback :
			function(place, fileName, workspace, baseurl) {
				macro.displayFile(place, fileName, workspace);
				displayMessage(locale.loadSuccess.format(fileName));
				$("input[type=text]", place).val("");
			};
		var defaults = config.defaultCustomFields;
		place = $("<div />").addClass("container").appendTo(place)[0];
		var workspace = bag ? "bags/%0".format(bag) : config.defaultCustomFields["server.workspace"];
		var baseURL = defaults["server.host"];
		baseURL += (baseURL[baseURL.length - 1] !== "/") ? "/" : "";
		baseURL = "%0%1/tiddlers".format(baseURL, workspace);
		//create the upload form, complete with invisible iframe
		var iframeName = "binaryUploadiframe%0".format(Math.random());
		// do not refactor following line of code to work in IE6.
		var form = $('<form action="%0" method="POST" enctype="multipart/form-data" />'.
					format(baseURL)).addClass("binaryUploadForm").
			appendTo(place)[0];
		macro.renderInputFields(form, options);
		$(form).
			append('<div class="binaryUploadFile"><input type="file" name="file" /></div>').
			append('<div class="binaryUploadSubmit"><input type="submit" value="Upload" disabled /></div>').
			submit(function(ev) {
				this.target = iframeName;
				options.target = iframeName;
				macro.uploadFile(place, baseURL, workspace, options);
			})
			.find('[type="file"]').bind('change', function() {
				$(form).find('[type="submit"]').prop('disabled', false);
			}).end();
		$('<div />').addClass("uploadProgress").text(locale.uploadInProgress).hide().appendTo(place);
		$("input[name=file]", place).change(function(ev) {
			var target = $(ev.target);
			var fileName = target.val();
			var title = $("input[type=text][name=title]", place);
			if(!title.val()) {
				title.val(fileName);
			}
		});
	},
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		params = paramString.parseParams(null, null, true);
		macro.createUploadForm(place, params[0]);
	},
	iFrameLoader: function(iframeName, callback) {
		var iframe = document.getElementById(iframeName); //jQuery doesn't seem to want to do this!?
		var locale = macro.locale;
		$(".userInput").addClass("notEdited"); // reset editing
		var finishedLoading = function() {
			callback();
		};
		var iFrameLoadHandler = function() {
			finishedLoading.apply();
			return;
		};

		iframe.onload = iFrameLoadHandler;
		//IE
		completeReadyStateChanges = 0;
		iframe.onreadystatechange = function() {
			if (++(completeReadyStateChanges) == 3) {
				iFrameLoadHandler();
			}
		};
	},
	displayFile: function(place, title, workspace) {
		var adaptor = store.getTiddlers()[0].getAdaptor();
		var context = {
			workspace: workspace,
			host: config.defaultCustomFields['server.host']
		};
		adaptor.getTiddler(title, context, null, function(context) {
			if(context.status) {
				store.addTiddler(context.tiddler);
				story.displayTiddler(place, title);
				var image = config.macros.image;
				if(image && image.refreshImage) {
					image.refreshImage("/%0/tiddlers/%1".format(workspace, title));
					image.refreshImage(title);
					image.refreshImage("/%0".format(title));
					image.refreshImage("%0/%1/tiddlers/%2".format(config.extensions.tiddlyweb.host, workspace, title));
				}
			} else {
				displayMessage(macro.locale.loadError.format(title));
			}
		});
	}
};

if(tiddlyspace) {
	config.macros.binaryUploadPublic = {
		handler: function(place, macroName, params, wikifier, paramString, tiddler) {
			var options = paramString.parseParams(null, null, true)[0];
			var bag = tiddlyspace.getCurrentBag("public");
			options.bag = bag;
			macro.createUploadForm(place, options);
		}
	};
	config.messages.privacySetting = config.options.chkPrivateMode ?
		"private" : "public";
	config.macros.binaryUpload.defaultWorkspace = tiddlyspace.
		getCurrentWorkspace(config.messages.privacySetting);
}

})(jQuery);
//}}}
//(2) For x-ray controls manufactured on or after June 10, 2006//

There shall be provided for each fluoroscopic tube:
* (i) A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in 1020.32(h)(2)(ii). The following requirements apply:
** (A) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every 6 seconds.
** (B) The fluoroscopic irradiation time shall also be displayed within 6 seconds of termination of an exposure and remain displayed until reset.
** (C) Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure.
* (ii) A signal audible to the fluoroscopist shall sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least 2 second.
//(1) Fluoroscopic equipment manufactured ''before May 19, 1995''//
* (i) Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in 1020.32(d)(3), except as specified in 1020.32(d)(1)(v).
* (ii) Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in 1020.32(d)(3), except as specified in 1020.32(d)(1)(v).
* (iii) Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) in either mode at the measurement point specified in 1020.32(d)(3), except as specified in 1020.32(d)(1)(v).
* (iv) Equipment may be modified in accordance with 1020.30(q) to comply with 1020.32(d)(2). When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:
** ''Modified to comply with 21 CFR 1020.32(h)(2).''
* (v) Exceptions:
** (A) During recording of fluoroscopic images, or
** (B) When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of the rates specified in 1020.32(d)(1)(i), (d)(1)(ii), or (d)(1)(iii) at the measurement point specified in 1020.32(d)(3), unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.
In [[FDA Inspections]] Situation I conditions are those conditions that provide evidence that there are significant errors in the manufacturers production process leading to defective devices.

Under these conditions inspectors identify system wide deficiencies and are instructed to terminate the routine inspecton and issue an Form [[FDA 483]] list of observations.

Situation I findings are as follows:
* Failure to establish and document a formal quality program
* Failure to validate significant manufacturing processes and quality tests
* Failure to establish and implement adequate record keeping procedures
* Failure to establish and implement adequate failure investigations
* Failure to ensure that finished devices meet all specifications before acceptance

FDA expects firms with [[Situation I]] conditions to fully examine their entire manufacturing process. Responses should indicate that the firm is performing a comprehensive assesment of its quality system to identify other problematic areas.
/***
|''Name''|TiddlySpaceInitialization|
|''Version''|0.7.3|
|''Description''|Initializes new TiddlySpaces the first time they are created|
|''Status''|@@beta@@|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/blob/master/src/plugins/TiddlySpaceInit.js|
|''CoreVersion''|2.6.1|
|''Requires''|TiddlySpaceConfig RandomColorPalettePlugin chrjs ImageMacroPlugin|
!TODO
* robust error notification and recovery
!MarkupPreHead
<!--{{{-->
<link href="/bags/%0_public/tiddlers.atom" rel="alternate"
	type="application/atom+xml" title="%0's public feed" />
<link rel="canonical" href="%1/" />
<!--}}}-->
!Code
***/
//{{{
(function($) {

var versionField = "tiddlyspaceinit_version";
var markupPreHead = store.getTiddlerText(tiddler.title + "##MarkupPreHead", "");
var tiddlyspace = config.extensions.tiddlyspace;
var currentSpace = tiddlyspace.currentSpace;
var tweb = config.extensions.tiddlyweb;

var plugin = config.extensions.TiddlySpaceInit = {
	version: "0.6",
	SiteTitle: "%0",
	SiteSubtitle: "a TiddlySpace",
	flagTitle: "%0SetupFlag",
	flagWarning: "Please do not modify this tiddler; it was created " +
		"automatically upon space creation.",

	dispatch: function(ev) {
		var title = plugin.flagTitle.format([currentSpace.name]);
		config.annotations[title] = plugin.flagWarning;
		if(currentSpace.type != "private") {
			return;
		}
		var tiddlers = [];
		var tid = store.getTiddler(title);
		if(tid) {
			curVersion = parseFloat(tid.fields[versionField]);
			reqVersion = parseFloat(plugin.version);
			if(curVersion < reqVersion) {
				plugin.update(curVersion, tid);
				tid.fields[versionField] = plugin.version;
				tid.incChangeCount();
				tid = store.saveTiddler(tid);
				tiddlers.push(tid);
			}
		} else { // first run
			tid = new Tiddler(title);
			tid.tags = ["excludeLists", "excludeSearch", "excludePublisher"];
			tid.fields = $.extend({}, config.defaultCustomFields);
			tid.fields[versionField] = plugin.version;
			tid.text = "@@%0@@".format([plugin.flagWarning]);
			tid = store.saveTiddler(tid);
			tiddlers = tiddlers.concat(plugin.firstRun(), tid);
		}
		autoSaveChanges(null, tiddlers);
	},
	update: function(curVersion, flagTiddler) {
		if(curVersion < 0.2) {
			this.createAvatar();
		}
		if(curVersion < 0.3) {
			flagTiddler.tags.pushUnique("excludePublisher"); // XXX: never persisted
		}
		if(curVersion < 0.5) { // v0.4 was faulty
			this.setupMarkupPreHead();
		}
		if(curVersion < 0.6) {
			this.purgeSystemSettings();
		}
	},
	pubTid: {
		tags: ["excludeLists", "excludeSearch"],
		fields: $.extend({}, config.defaultCustomFields, {
			"server.workspace": tiddlyspace.getCurrentWorkspace("public")
		})
	},
	makeTiddlerIfNot: function(tiddler) {
		if (!store.tiddlerExists(tiddler.title)) {
			$.extend(true, tiddler, plugin.pubTid);
			return [store.saveTiddler(tiddler)];
		} else {
			return [];
		}
	},
	firstRun: function() {
		var tiddlers = [];
		// generate Site*itle
		$.each(["SiteTitle", "SiteSubtitle"], function(i, item) {
			var tid = new Tiddler(item);
			tid.text = plugin[item].format([currentSpace.name]);
			tiddlers.push.apply(tiddlers,
				plugin.makeTiddlerIfNot(tid));
		});
		// generate public ColorPalette
		var tid = new Tiddler("ColorPalette");
		tid.text = config.macros.RandomColorPalette.generatePalette({
			saturation_pale: 0.67, saturation_light: 0.53,
			saturation_mid: 0.43, saturation_dark: 0.06,
			pale: 0.99, light: 0.85, mid: 0.5, dark: 0.31
		},
			false);
		tiddlers.push.apply(tiddlers, plugin.makeTiddlerIfNot(tid));
		this.createAvatar();
		this.setupMarkupPreHead();
		return tiddlers;
	},
	// remove _cookie slices (TiddlyWiki 2.6.2 beta 6 remnants)
	purgeSystemSettings: function() {
		var ss = store.getTiddler("SystemSettings");
		if(ss) {
			var lines = ss.text.split("\n");
			var persistentOptions = $.grep(lines, function(line, i) {
				return line.indexOf("_cookie:") == -1;
			});
			ss.text = persistentOptions.join("\n");
			ss = store.saveTiddler(ss);
			autoSaveChanges(null, [ss]);
		}
	},
	createAvatar: function() {
		var avatar = "SiteIcon";
		var host = tweb.host;
		var notify = function(xhr, error, exc) {
			displayMessage("ERROR: could not create avatar - " + // TODO: i18n
				"%0: %1".format([xhr.statusText, xhr.responseText]));
			// TODO: resolve!?
		};

		var pubBag = tiddlyspace.getCurrentBag("public");
		var tid = new tiddlyweb.Tiddler(avatar);
		tid.bag = new tiddlyweb.Bag(pubBag, host);

		var callback = function(data, status, xhr) {}; // avatar already exists; do nothing
		var errback = function(xhr, error, exc) {
			if(xhr.status != 404) {
				return;
			}
			// copy default avatar
			var _notify = function(tid, status, xhr) {
				displayMessage("created avatar"); // TODO: i18n
				var image = config.macros.image;
				if(image && image.refreshImage) {
					var uri = "/%0/tiddlers/SiteIcon".
						format(tiddlyspace.getCurrentWorkspace("public"));
					image.refreshImage(uri);
					image.refreshImage("SiteIcon");
				}
			};
			var _callback = function(tid, status, xhr) {
				tid.title = avatar;
				tid.bag.name = pubBag;
				delete tid.etag;
				tid.put(_notify, notify); // TODO: add to current session document (via adaptor?)
			};
			tweb.getUserInfo(function(user) {
				var avatarTitle = currentSpace.name == user.name ?
					"defaultUserIcon" : "defaultSiteIcon";
				var tid = new tiddlyweb.Tiddler(avatarTitle);
				tid.bag = new tiddlyweb.Bag("common", host);
				tid.get(_callback, notify);
			});
		};
		tid.get(callback, errback);
	},
	savePublicTiddlerText: function(title, text, pubWorkspace) {
		var tid = new Tiddler(title);
		tid.text = text;
		tid.tags = ["excludeLists"];
		tid.fields = $.extend({}, config.defaultCustomFields);
		tid.fields["server.workspace"] = pubWorkspace;
		tid.fields["server.page.revision"] = "false";
		tid = store.saveTiddler(tid);
		autoSaveChanges(null, [tid]);
	},
	setupMarkupPreHead: function() {
		var pubWorkspace = tiddlyspace.getCurrentWorkspace("public");
		var existing = store.getTiddler("MarkupPreHead");
		if(!existing || existing.fields["server.workspace"] != pubWorkspace) {
			var context = this;
			tweb.getStatus(function(status) {
				var text = markupPreHead.format(currentSpace.name,
					tiddlyspace.getHost(status.server_host, currentSpace.name));
				context.savePublicTiddlerText("MarkupPreHead", text,
					pubWorkspace);
			});
		}
		// also set up DefaultTiddlers
		var title = "DefaultTiddlers";
		existing = store.getTiddler(title) || new Tiddler(title);
		if(existing.fields["server.workspace"] != pubWorkspace) {
			var text = existing.text || store.getShadowTiddlerText(title);
			this.savePublicTiddlerText(title, text, pubWorkspace);
		}
	}
};

$(document).bind("startup", plugin.dispatch);

})(jQuery);
//}}}
Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. [[Design Output]] procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.
!Attention points
* Design output control must ensure that each describes initial through final design output is documented, reviewed ad approved by approproate management.
* The FDA expects that the more complex the process is, the more documentation is associated with control of the process.
* Items that must be documented are:
** Output documents for all new design or development activities
** Modifications to a new or existing regulated product
** The intented use of each device, including user and patient needs

The output team is usually tasked to do the following:
* Create a [[Functional Model]] of the device
* Partition the design apprioately to facilitate design feasibility
* Identify critical design outputs
* Continue development and complete the [[Risk Analisys]] by appropriate [[Risk Management Procedures]]
* Finalize and approve the [[Functoinal Design Specification]] created by the project team
* Finish [[Detailed Design Documents]]
* Define physical design specifications including architectural requirements of the device, its subassemblies and components
* Define packaging specifications
* Implement [[Change Control Procudures]] for all activities in the design output specifications stage
* Create a master [[Verification Plan]] and [[Test Plans]] use to verify that the design conforms to its safety & reliability requirements
* Review and approve all documents used to implement the preding activities
* Prepare for a [[Formal Design Review]] and approval at the completion of the design process.

Mechanisms to document control over output specifications might include the following:
* A [[Design Input Requirements Control Matrix]]
* Detailed input documents
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Failure Mode, Effect and Criticality Analysis//'' (FMECA) is [[FMEA|Failure Mode and Effect Analysis]] process that includes an assesment of the criticality of identified fault modes.
In the [[FDA Regulations]] description of the ''Design Input Document Control Matrix'' is regarded to be a good mechanism to control design input documentation:
* By establishing a document that provides overall control to the design input process, firms provide the FDA with a good verification mechanism
* Include a checklist that identifies completed activities (in order to spot incomplete, ambigious or conflicting requirements)
* Elements that should be documented are:
** The purpose oof the device and its intended use
** A description or theory of operation
** Components of the device
** Operational modes
** Prelimairy [[Risk Analysis]]
** Controls and alarms
** Interfaces or connectors
** Standards or applicable regulations
** Performance or reliability specifications
** Environmental specifications
** Physical specificatsions
** Safety specifications
** Master verification plan and master validatio pan
** Preliminairy labels and labeling
The Legal Owner is the entity that is responsible for the [[DMS]] and [[DHF]]. The production site is the [[Legal Owner]]
!Upload an icon
<<tiddler spaceIcon>>
!Describe your space
If you haven't already done so, you should provide a brief decscription of yourself and what you're using this space for. To do this, just edit the [[SiteInfo]] tiddler (keeping the title the same of course).

!Change the title
<<tiddler spaceTitle>>
!Change the theme
<<tiddler colorScheme>>
!Change the menu
If you'd like to change the menu items along the top, you can edit the [[MainMenu]] tiddler.

!Change the default tiddlers
<<tiddler setDefaultTiddlers>>
!More Advanced customisations
If you know HTML and CSS, you can edit some or all of the following tiddlers to customise your space further:
* PageTemplate
* EditTemplate
* ViewTemplate
* StyleSheet
Summary of regulations of Food and Drug Administration rules for suppliers of Healthcare equipment
These regulations implement the FDA's criteria for and authority requiring manufacturers to:
# Register initially using form [[FDA 2891]] and update annually thereafter
# To list manufactured devices using form [[FDA 2892]] and to update this list annually.
This is the regulation that initiatiates FDA oversight
6.1 Provision of resources

The organization shall determine and provide the resources needed
a) to implement the quality management system and to maintain its effectiveness, and
b) to meet regulatory and customer requirements.
{{{
config.macros.GoogleVideoFragment = {
  handler: function (place, macroName, params, wikifier, paramString, tiddler)
  {
     var movie;

     if (params[0] != null)
     {
           movie = params[0];
     }

     resultString = '<html>';
     resultString += '<object width="425" height="344">';
     resultString += '<param name="movie" value="http://www.youtube.com/v/';
     resultString += movie;
     resultString += '&hl=en&fs=1">';

     resultString += '</param><param name="allowFullScreen" value="true">';
     resultString += '</param><param name="allowscriptaccess" value="always">';
     resultString += '</param><embed src=';
     resultString += 'http://www.youtube.com/v/';

     resultString += movie;
     resultString += '&hl=en&fs=1" ';
     resultString += 'type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="425" height="344">';
     resultString += ' </embed></object> ';
     resultString += '</html>';

     wikify(resultString,place);
   }
 }
}}}
/***
|''Name''|TiddlyTagMindMap2|
|''Requires''|excanvas jit-yc|
|''Version''|2.0.0|
!Parameters
See http://mindmaps.tiddlyspace.com#How to use
* fieldType
!StyleSheet
.ttmm {
	overflow: hidden;
	position: relative;
	height: 200px;
}
.ttmm .node {
	cursor: pointer;
	font-size: 0.7em;
}

.nodeMissing {
	color: #ccc;
}

.nodeVisited {
	color: Purple;
}

.depth0 {
	border: solid 1px black;
}
!Todo
* html labels have id of the node. This is really bad and should be fixed in the jit core.
***/
//{{{
(function($){

var tiddler = {title: "TiddlyTagMindMap2Plugin"};
var name = "StyleSheetTiddlyTagMindMap";
config.shadowTiddlers[name] = store.getTiddlerText(tiddler.title +
"##StyleSheet");
store.addNotification(name, refreshStyles);
config.shadowTiddlers.TiddlyTagMindMapNodeTemplate = "<<view title text>>";
var macro = config.macros.TiddlyTagMindMap = {
	
	rootNode: "TiddlyTagMindMapRootNode",
	defaultOptions: {
		id: null,
		rootNode: null,
		field: [ "tags" ], // dictates the parent node
		fieldsAreList: true,
		width: null,
		height: null,
		nodeType: "square",
		nodeColor: '#ddeeff',
		nodeSize: 4,
		centerOn: false,
		edgeColor: '#C17878',
		directed: false,
		edgeType: null,
		edgeWidth: 1.5,
		template: "TiddlyTagMindMapNodeTemplate",
		filter: false,
		maxNodeNameLength: false,
		labelDepth: false,
		exclude: "excludeLists",
		vizType: "radial",
		animate: true, //*
		ignoreLoneNodes: true, //*
		caseSensitive: false, //*
		hideRoot: true,
		valuePrefix: false
	},
	init: function() {
		macro._active = {};
		var _displayTiddler = Story.prototype.displayTiddler;
		Story.prototype.displayTiddler = function(srcElement,tiddler,template,animate,unused,customFields,toggle,animationSrc) {
			var el = _displayTiddler.apply(this, arguments);
			var id = typeof(tiddler) == 'string' ? tiddler : tiddler.title;
			macro.centerAll(id);
			return el;
		};
		
		var _saveTiddler = TiddlyWiki.prototype.saveTiddler;
		TiddlyWiki.prototype.saveTiddler = function(title, newTitle, newBody, modifier,
				modified, tags, fields, clearChangeCount, created, creator) {
			var tid = _saveTiddler.apply(this, arguments);
			macro.updateAllGraphs();
			return tid;
		};
		var _removeTiddler = TiddlyWiki.prototype.removeTiddler;
		TiddlyWiki.prototype.removeTiddler = function(title) {
			var tid = store.getTiddler(title);
			var flag = _removeTiddler.apply(this, arguments);
			macro.updateAllGraphs(title);
			return flag;
		};
	},
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		var options = macro.getOptions(place, paramString);
		var data = macro.getData(options);
		var id = options.id || "ttmm2_%0".format([Math.random()]);
		if(macro._active[id]) {
			$(document.getElementById(id)).empty();
		}
		var container = $("<div />").addClass("ttmm").attr("id", id).
			css({width: options.width, height: options.height}).appendTo(place)[0];
		$(container).dblclick(function(ev) {
			ev.stopPropagation();
		});
		macro.renderGraph(container, data, options);
	},
	getNodeLabelId: function(containerId,id) {
		return "node-%0-%1".format([containerId, id])
	},
	updateAllGraphs: function(changed) {
			for(var i in macro._active) {
				var el = document.getElementById(i);
				if(el) {
					var cache = macro._active[i];
					var deleted = document.getElementById(macro.getNodeLabelId(i, changed));
					if(cache) {
						var options = cache.options;
						var viz = cache.viz;
						var data = macro.getData(options);
						macro._refresh(viz, data, options);
						viz.refresh();
						$(deleted).remove();
					}
				} else {
					macro._active[i] = false;
				}
			}
	},
	centerAll: function(id) {
		for(var i in macro._active) {
			var el = document.getElementById(i);
			if(el) {
				var cache = macro._active[i];
				if(cache) {
					var viz = cache.viz;
					if(viz.graph.hasNode(id)) {
						viz.onClick(id);
					}
				}
			} else {
				macro._active[i] = false;
			}
		}
	},
	renderGraph: function(container, data, options) {
		if(options.vizType == "hypertree") {
			macro._renderHypertree(container, data, options);
		} else {
			macro._renderRGraph(container, data, options);
		}
	},
	_getViz: function(type, container, options) {
		var containerId = $(container).attr("id");
		var viz = new $jit[type]({ 
			injectInto: containerId,
			Navigation: {
				enable: true,
				panning: true,
				zooming: 10
			},
			Node: {
				color: options.nodeColor,
				type: options.nodeType,
				overridable: true,
				width: options.nodeSize,
				dim: options.nodeSize,
				height: options.nodeSize
			},
			Edge: {
				color: options.edgeColor,
				lineWidth: options.edgeWidth,
				type: options.edgeType,
				overridable: true,
				dim: 15
			},
			onBeforeCompute: function(node){},
			onAfterCompute: function(){},
			onCreateLabel: function(domElement, node){
				var el = $(domElement).empty();
				if(!options.maxNodeNameLength) {
					var ctx = store.tiddlerExists(node.id) ? store.getTiddler(node.id) : new Tiddler(node.id);
					var template = store.getTiddlerText(options.template);
					template = template ? template : store.getTiddlerText("TiddlyTagMindMapNodeTemplate");
					wikify(template, domElement, null, ctx);
				} else {
					var text = el.text();
					var maxLength = options.maxNodeNameLength;
					if(maxLength) {
						if(text.length > maxLength) {
							var diff = (text.length - maxLength);
							text = "%0...".format([text.slice(0, text.length - diff)]);
						}
					}
					el.text(text);
				}
				el.attr("id", macro.getNodeLabelId(containerId, node.id));
				var rgraph = this;
				var wasClick = false;
				$(domElement).click(function(ev){
					wasClick = true;
					window.setTimeout(function() {
						if(wasClick) {
							var cache = macro._active[containerId];
							if(cache && cache.visitedNodes) {
								cache.visitedNodes[node.id] = true;
							}
							options.centerOn = node.id;
							viz.onClick(node.id);
						}
					}, 300);
				});
				$(domElement).dblclick(function(ev) {
					wasClick = false;
					story.displayTiddler(ev.target, node.id);
					ev.stopPropagation();
					return false;
				});
			},
			onPlaceLabel: function(domElement, node){
				var el = $(domElement);
				var depth = node._depth;
				if(options.labelDepth && depth > options.labelDepth) {
					el.hide();
					return;
				}
				el.show();
				var existingDepth = el.attr("node-depth");
				if(existingDepth) {
					el.removeClass("depth%0".format([existingDepth]));
				}
				el.attr("node-depth", depth);
				el.addClass("depth%0".format([depth]));
				if(options.hideRoot && node.data.root) {
					el.hide();
				}
				if(node.data.missing) {
					el.addClass("nodeMissing");
					if(options.missingColor) {
						el.css({ color: "#ccc" });
					}
				}
				var cache = macro._active[containerId];
				if(cache && cache.visitedNodes && cache.visitedNodes[node.id]) {
					el.addClass("nodeVisited");
				}
			}
		});
		return viz;
	},
	_refresh: function(viz, data, options) {
		viz.labels = false; // hack
		viz.loadJSON(data);
    //compute positions and plot.
    try {
			viz.refresh();
		} catch(e) {
		}
		if(options.centerOn) {
			viz.onClick(options.centerOn);
		}
	},
	_patch: function(viz) {
		// customisations
		var _plotLine = viz.constructor.Plot.prototype.plotLine;
		var _plotNode = viz.constructor.Plot.prototype.plotNode;
		viz.constructor.Plot.prototype.plotLine = function(adj, canvas, animating) {
			if(adj.nodeFrom.id != macro.rootNode && adj.nodeTo.id != macro.rootNode) {
				_plotLine.apply(this, arguments);
			}
		}
		viz.constructor.Plot.prototype.plotNode = function(node, canvas, animating) {
			if(node.id != macro.rootNode) {
				_plotNode.apply(this, arguments);
			}
		};
	},
	_renderHypertree: function(container, data, options) {
		var ht = macro._getViz("Hypertree", container, options);
		macro._patch(ht);
		var id = $(container).attr("id");
		macro._active[id] = {
			data: data,
			viz: ht,
			options: options,
			visitedNodes: {}
		};
		macro._refresh(ht, data, options);
    //end
    ht.controller.onAfterCompute();
	},
	_renderRGraph: function(container, data, options) {
		var rgraph = macro._getViz("RGraph", container, options);
		macro._patch(rgraph);
		//load JSON data
		var id = $(container).attr("id");
		macro._active[id] = {
			data: data,
			viz: rgraph,
			options: options,
			visitedNodes: {}
		};
		macro._refresh(rgraph, data, options);
	},
	refresh: function(container) {
		var id = $(container).attr("id");
		var cache = macro._active[id];
		if(cache) {
			var data = cache.data;
			var options = cache.options;
			var rgraph = cache.viz;
		}
	},
	getData: function(options) {
		var root = options.rootNode || macro.rootNode;
		options = options ? options : macro.defaultOptions;
		options._tiddlers = options.filter ? store.filterTiddlers(options.filter) : store.getTiddlers(null, options.exclude);
		return macro._createNode(root, options);
	},
	getOptions: function(container, paramString) {
		var listOptions = ["field"]; // will be saved as lists
		var numberOptions = ["labelDepth"];
		var args = paramString.parseParams("name", null, true, false, true)[0];
		var options = {};
		merge(options, macro.defaultOptions);
		for(var id in args) {
			if(true) {
				var p = args[id];
				if(listOptions.contains(id)) {
					options[id] = p;
				} else if(numberOptions.contains(id)){
					options[id] = parseFloat(p[0]);
				} else {
					options[id] = p[0];
				}
			}
		}
		options.fieldsAreList = options.fieldType && options.fieldType == "string" ? false : true; 
		options.width = options.width ? parseInt(options.width) : $(container).width();
		options.height = options.height ? parseInt(options.height) : $(container).height();
		options.edgeType = options.directed ? "arrow" : options.edgeType;
		options.hideRoot = options.hideRoot && options.hideRoot == "no" ? false : true;
		// note hyperline doesn't work for RGraph
		var defaultEdgeType = options.vizType == "hypertree" ? "hyperline" : "line";
		if(!options.edgeType) {
			options.edgeType = defaultEdgeType;
		} else {
			options.edgeType = options.edgeType == "hyperline" && options.vizType != "hypertree" ? "line" : options.edgeType;
		}
		return options;
	},
	lookupFieldValue: function(tiddler, options) {
		var allValues = [];
		for(var i = 0; i < options.field.length; i++) {
			var fieldName = options.field[i];
			var values = tiddler[fieldName] ? tiddler[fieldName] : tiddler.fields[fieldName];
			if(options.fieldsAreLists) {
				values = typeof(values) == "string" ? values.readBracketedList() : values;
			} else {
				values = typeof(values) == "string" ? [ values ] : values;
			}
			if(values) {
				for(var j = 0; j < values.length; j++) {
					allValues.pushUnique(values[j]);
				}
			}
		}
		return allValues;
	},
	lookupTiddlers: function(tiddlers, value, options) {
		var matches = [];
		for(var i = 0; i < tiddlers.length; i++) {
			var tiddler = tiddlers[i];
			var values = macro.lookupFieldValue(tiddler, options);
			if(values && values.indexOf(value) > -1) {
				matches.push(tiddler);
			}
		}
		return matches;
	},
	_getChildNodes: function(title, options) {
		var children = [];
		var tiddlers = options._tiddlers;
		if(title == macro.rootNode) { // get all tiddlers with no tags
			var tags = {};
			for(var i = 0; i < tiddlers.length; i++) {
				var tiddler = tiddlers[i];
				var values = macro.lookupFieldValue(tiddler, options);
				if(values.length === 0) {
					var node = macro._createNode(tiddler.title, options);
					node.data.orphan = true;
					if(node) {
						children.push(node);
					}
				} else {
					for(var j = 0; j < values.length; j++) {
						var value = values[j];
						var tiddler = store.getTiddler(value);
						if(!tiddler) {
							var node = macro._createNode(value, options);
							if(node) {
								node.data.orphan = true;
								children.push(node);
							}
						}
					}
				}
			}
		} else {
			var lookup = options.valuePrefix ? "%0%1".format([options.valuePrefix, title]) : title;
			var matches = macro.lookupTiddlers(tiddlers, lookup, options);
			if(matches) {
				// TODO: support strings to array
				for(var i = 0; i < matches.length; i++) {
					var node = macro._createNode(matches[i].title, options);
					if(node) {
						children.push(node);
					}
				}
			}
		}
		return children;
	},
	_createNode: function(title, options) {
		var children = macro._getChildNodes(title, options);
		var node = {
			id: title,
			name: title,
			data: {
				missing: store.tiddlerExists(title) ? false : true,
				visited: false,
				root: title == macro.rootNode,
				weight: children.length
			},
			children: children
		};
		return node;
	}
};
})(jQuery);
//}}}
{{{
config.macros.YouTubeFragment = {
  handler: function (place, macroName, params, wikifier, paramString, tiddler)
  {
     var movie;

     if (params[0] != null)
     {
           movie = params[0];
     }

     resultString = '<html>';
     resultString += '<object width="425" height="344">';
     resultString += '<param name="movie" value="http://www.youtube.com/v/';
     resultString += movie;
     resultString += '&hl=en&fs=1">';

     resultString += '</param><param name="allowFullScreen" value="true">';
     resultString += '</param><param name="allowscriptaccess" value="always">';
     resultString += '</param><embed src=';
     resultString += 'http://www.youtube.com/v/';

     resultString += movie;
     resultString += '&hl=en&fs=1" ';
     resultString += 'type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="425" height="344">';
     resultString += ' </embed></object> ';
     resultString += '</html>';

     wikify(resultString,place);
   }
 }
}}}
FDA
A ''comprehensive inspection'' is an inspection performed on all elements of a firms quality system subject to FDA jurisdiction, to asses the firms compliance status.

In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] a ''//Design Risk Analysis//'' is the ongoing investigation of available information to identify hazards, potential failures, their causes or mechanisms, and the degree of risk to ensure these risks are addressed during the design process or any subsequent [[Design Review]] and change.
In the FDA's Quality System Requirements the ''Design Master Record'' (DMR) means a compilation of records containting the procedures and specifications for a finished device.
This site is build as a [[tiddlywiki|http://www.tiddlywiki.com]] and hosted using [[tiddlyspace|http://www.tiddlyspace.com]] technololgy.  Reading ~TiddlyWikis is easy, but takes some getting used to. Rather than scrolling up and down a long web page or word processing document, you open small chunks of information ("microcontent") written in boxes called "tiddlers." You read what you need from a tiddler, then close it with the close button at the top right hand corner of the tiddler.

When a tiddler is opened up, it appears at the top of the screen or below the tiddler used to link to it. After opening a few tiddlers in succession, you might feel overwhelmed by all the open tiddlers. Not to worry.

    * You can close every tiddler but the one you are using by clicking on the close others button.
    * If you have multiple tiddlers open, you can use the jump button to quickly go to the open tiddler you desire without having to scroll up and down.
    * See here for information on the other buttons at the top right of the tiddler.

To search for a tiddler, you can use the search window at the top right of the screen. All the tiddlers that contain the word that you search for will appear.  Use 'search' on (right of the screen) to find information on a topic, for instance:
* Search for M3 to find all notes taken during module '3'. Module numbers can be found at the left
* Search for 'Reading' to see abstract of articles
* Search for 'Session notes' to see notes taken during the training
Click on a module on the left to navigate to a certain module or module session.
/***
|''Name''|TiddlySpaceSearcher|
|''Version''|0.2.5|
|''Requires''|TiddlySpaceConfig TiddlySpaceFollowingPlugin|
***/
//{{{
(function($) {
var tiddlyspace = config.extensions.tiddlyspace;
var tsScan = config.macros.tsScan;

config.shadowTiddlers.SearchTemplate = "<<view server.bag SiteIcon label:no width:24 height:24 preserveAspectRatio:yes>> <<view server.bag spaceLink title external:no>> in space <<view server.bag spaceLink>>";
config.shadowTiddlers.StyleSheetSearch = [".resultsArea .siteIcon { display: inline; }",
	".searchForm {text-align: left;}"].join("\n");
store.addNotification("StyleSheetSearch", refreshStyles);

var search = config.macros.tsSearch = {
	locale: {
		advanced: "Advanced Options",
		header: "Search",
		resultsHeader: "Results (%0)",
		find: "find",
		noResults: "No tiddlers matched your search query",
		query: "QUERY: ",
		error: "please provide a search query or a tag, modifier or title!",
		titleAdvanced: "where the title is",
		modifierAdvanced: "where the last modifier is",
		spaceAdvanced: "only in the space: ",
		notspaceAdvanced: "but not in the spaces: ",
		tagsAdvanced: "with the tags: "
	},
	andConstructor: function(container, label, fieldname, negationMode) {
		var tags = $("<div />").appendTo(container);
		$('<span />').text(label).appendTo(tags);
		var id = "area" + Math.random();
		container = $("<span />").attr("id", id).appendTo(tags)[0];
		function add(container) {
			var el = $('<input type="text" />').attr("field", fieldname).appendTo(container);
			if(negationMode) {
				el.attr("negation", "true");
			}
		}
		add(container);
		var el = $("<button />").text("AND").click(function(ev) {
			add($(ev.target).data("container"));
			ev.preventDefault();
		}).appendTo(tags);
		$(el).data("container", container);
	},
	fieldConstructor: function(container, label, field) {
		container = $("<div />").appendTo(container)[0];
		$("<span />").text(label).appendTo(container);
		$("<input />").attr("text", "input").attr("field", field).appendTo(container);
	},
	advancedOptions: function(form) {
		var locale = search.locale;
		var container = $("<div />").addClass("tsAdvancedOptions").appendTo(form)[0];
		$("<h2/ >").text(search.locale.advanced).appendTo(container);
		$("<div />").addClass("separator").appendTo(container);
		search.fieldConstructor(container, locale.titleAdvanced, "title");
		search.fieldConstructor(container, locale.modifierAdvanced, "modifier");
		search.fieldConstructor(container, locale.spaceAdvanced, "space");
		search.andConstructor(container, locale.notspaceAdvanced, "space", true);
		search.andConstructor(container, locale.tagsAdvanced, "tag");
	},
	constructSearchQuery: function(form) {
		var data = [], select = [];
		var query = $("[name=q]", form).val();
		if(query) {
			data.push("q=%0".format(query));
		}

		// add tags, fields etc..
		$("[field]", form).each(function(i, el) {
			var val = $(el).val();
			var name = $(el).attr("field");
			var negate = $(el).attr("negation") == "true";
			if(val && name) {
				val = encodeURIComponent(val);
				val = negate ? "!" + val : val;
				if(name == "space") {
					val += "_public";
					name = "bag";
				}
				if(negate) {
					select.push("select=%0:%1".format(name,val));
				} else {
					var prefix = data.length === 0 ? "q=" : "";
					data.push('%0%1:"%2"'.format(prefix, name, val));
				}
			}
		});
		var dataString = data.join(" ");
		if(dataString.length === 0 && !query) {
			return false;
		}
		var selectStatement = select.join("&");
		if(dataString.length > 0 && selectStatement.length > 0) {
			dataString += "&";
		}
		dataString += selectStatement;
		return "/search?%0".format(dataString);
	},
	constructForm: function(place) {
		var locale = search.locale;
		$("<h1 />").text(locale.header).appendTo(place);
		var form = $("<form />").appendTo(place)[0];
		$('<input type="text" name="q" />').appendTo(form);
		$('<input type="submit" />').val(locale.find).appendTo(form);
		search.advancedOptions(form);
		var query = $('<h2 class="query"/>').appendTo(place)[0];
		var results = $("<div />").appendTo(place).addClass("resultsArea")[0];
		var lookup = function(url) {
			if(!url) {
				results.empty().addClass("error").text(locale.error);
				return;
			}
			config.extensions.tiddlyweb.getStatus(function(status) {
				$(query).text(locale.query);
				var href = status.server_host.url + url;
				$("<a />").attr("href", href).text(href).appendTo(query);
				tsScan.scan(results, { url: url, emptyMessage: search.locale.noResults, cache: true,
					template: "SearchTemplate", sort: "title", callback: function(tiddlers) {
						$("<h2 />").text(locale.resultsHeader.format(tiddlers.length)).prependTo(results);
					}
				});
			});
		};
		$(form).submit(function(ev) {
			ev.preventDefault();
			var url = search.constructSearchQuery(form);
			config.macros.tsSearch.lastSearch = url;
			lookup(url);
		});
		if(search.lastSearch) {
			lookup(search.lastSearch);
		}
		return form;
	},
	handler: function(place) {
		var container = $("<div />").addClass("searchForm").appendTo(place)[0];
		search.constructForm(container);
	}
};

})(jQuery);
//}}}
<<formTiddler [[NewBookTemplate]]>>

<html>
<iframe src="http://rcm.amazon.com/e/cm?t=httptiddlyweb-20&o=1&p=8&l=as1&asins=0873894553&ref=tf_til&fc1=000000&IS2=1&lt1=_blank&m=amazon&lc1=0000FF&bc1=000000&bg1=FFFFFF&npa=1&f=ifr" style="width:120px;height:240px;" scrolling="no" marginwidth="0" marginheight="0" frameborder="0"></iframe>
</html>
<data>{"Author":"Gordan Hamack","Rating":"***"}</data>

!Summary
!!Chapter 1 - Introduction
!!!Device classification
<<tiddler [[Device classification]]>>
!!!CFR
<<tiddler [[CFR]]>>
!!Chapter 2 - FDA Inspections
!!!FDA Inspections
<<tiddler [[FDA Inspections]]>>
!!Chapter 3 - Design Controls
<<tiddler [[CFR 21-820 - Quality System Regulations]]>>
!!Chapter 4 - Design Controls
<<tiddler [[CFR 21-820.30 - Design Controls]]>>
!!Chapter 5 - Document Controls
<<tiddler [[CFR 21-840 - Document Controls]]>>
At $t = 0$ $P_0$ is defined to be developer productivity without legacy obligations
(1) $\large P(0) = P_0$

At time $t$ the developer productivity is given by the following equation. $r$ denotes the rate in which productivity declines over time (see [[Derivation of developer productivity decline function]])
(2) $\large P(t) = P_0 \cdot e^{-r t} dt$

We know that after 1 year a developer has produced 10KLoc:
(3a) $\large \int^1_0 P_0 \cdot e^{-r t} dt$ = ${ProductionPerYear} = 10$

We know that over the full life time a developer can maximally maintain 50KLoc:
(4a) $\large \int^\infty_0 P_0 \cdot e^{-r t} dt$ = ${MaxMaintenance}  = 50$

Using the [[Substitution rule]] we can see that:
(5a) $\large u = -rt$
(5b) $\large t = 0 => u = 0$
(5c) $\large t = \infty => u = - r \cdot \infty$
(5d) $\large t = 1 => u = - r$
(5e) $\large du = -rdt => dt = $ $\Large -\frac{1}{r}$$\large du$

So that:
(3b) $\large -P_0 \frac {1}{r} \int^{-r}_0 e^u du$ = ${ProductionPerYear}$
(3c) $\large -P_0 \frac {1}{r} (e^{-r} - e^0)$ = ${ProductionPerYear}$
(3d) $\large P_0 \frac {1-e^r}{r}$ = ${ProductionPerYear}$
(3e) $\large P_0 = $$\Large \frac{{ProductionPerYear} \cdot r}{1-e^{-r}} $

(4b) $\large -P_0 \frac {1}{r} \int^{-\infty}_0  \cdot e^u du$ = ${MaxMaintenance}$
(4c) $\large -P_0 \frac {1}{r} (e^{-\infty} - e^0)$ = ${MaxMaintenance}$
(4d) $\large -P_0 \frac {1}{r} (0 -1)$ = ${MaxMaintenance}$
(4e) $\large \frac {P_0}{r}$ = ${MaxMaintenance}$
(4f) $\large P_0$ = ${MaxMaintenance} \cdot r $

Combining (3e) and (4f) we get:
(6a) $\large {MaxMaintenance} \cdot r = \frac{{ProductionPerYear} \cdot r}{1-e^{-r}}$
(6b) $\large {1-e^{-r}} = \frac{{ProductionPerYear} \cdot r}{{MaxMaintenance} \cdot r}$
(6c) $\large -e^{-r} = \frac{{ProductionPerYear}}{{MaxMaintenance}} -1$
(6d) $\large e^{-r} = 1 - \frac{{ProductionPerYear}}{{MaxMaintenance}} $
(6e) $\large -r =  ln(1- \frac{ProductionPerYear}{{MaxMaintenance}})$
(6f) $\large r =  -ln(1- \frac{ProductionPerYear}{{MaxMaintenance}})$

Which results in the following values for $r$ and $P_0$
(6f) $\large r = -ln(1-10/50) = 0.22314355$
(4g) $\large P_0 = 50 * 0.22314355 = 11.1571775657 $
http://htmljs.tiddlyspace.com/jquery.js
http://htmljs.tiddlyspace.com/htmljs-wikiupgrade.js
http://www.artofproblemsolving.com/Wiki/index.php/LaTeX:Commands
!UserUnplugged
<<TiddlySpaceLogin>>

!SpaceUnplugged
{{unpluggedSpaceTab{
{{wizard{
<<image unsyncedIcon width:48>> <<message messages.syncExplanation>>
}}}
{{wizard syncKey{
{{keyHeading{
Key}}}
{{changedServer keyItem{<<message macros.sync.syncStatusList.changedServer.text>>}}} {{changedBoth keyItem{<<message macros.sync.syncStatusList.changedBoth.text>>}}} {{changedLocally keyItem{<<message macros.sync.syncStatusList.changedLocally.text>>}}} {{notFound keyItem{<<message macros.sync.syncStatusList.notFound.text>>}}}
}}}
<<sync>>

!User
{{textRight{
<<TiddlySpaceLogout>>
<<tabs txtUserTab
	"Your Identities" "Manage your identities" [[Backstage##Identities]]
	"Your Spaces" "Maintain your spaces and create new ones" [[Backstage##UserSpaces]]
	"Your Password" "Change your password" [[Backstage##Password]]
>>
}}}

!Menu
{{tiddlyspaceMenu{
<<message messages.memberStatus>> <<homeLink>>
{{unsyncedList{<<message messages.syncListHeading>> <<list filter [is[unsynced]]>>}}}

<<tabs txtTiddlySpaceTab
search "search across TiddlySpace" Backstage##Search
help "quick access to useful space resources" Backstage##Resources
>>
running TiddlySpace@glossary version <<message extensions.tiddlyweb.status.tiddlyspace_version>>
}}}

!Resources
[[blog|@@blog]]
[[documentation|@@docs]]
[[featured spaces|@@featured]]

!Search
<<tsSearch>>

!Space
<<followSpace>>
<<tabs txtSpaceTab
	members Members Backstage##SpaceMembers
	includes "include spaces" Backstage##SpaceInclusions
	tiddlers "tiddlers control panel" Backstage##Tiddlers
	plugins "Manage installed plugins" PluginManager
	batch "Perform batch operations on public/private tiddlers" Backstage##BatchOps
	options "TiddlyWiki options" Backstage##Options
	tweaks "Tweak the appearance and behaviour of TiddlyWiki" AdvancedOptions
	import "Import tiddlers from a TiddlyWiki" Backstage##FileImport
	export "Export this TiddlySpace for offline use" Backstage##Export
>>

!FileImport
<<fileImport>>

!Export
You can download this TiddlySpace as an offline TiddlyWiki:
{{chunkyButton{<<exportSpace>>}}}

!Identities
You can associate your account with multiple identities. If you have an open id for example you could log into TiddlySpace with that as well as a TiddlySpace user account.
<<TiddlySpaceIdentities add>>
{{inlineList{
	<<TiddlySpaceIdentities list>>
}}}
{{backstageClear{}}}

!Login
<<tabs txtLoginTab 
"TiddlySpace Username" "Login via a TiddlySpace username and password" Backstage##UserUnplugged
"OpenID" "Login via an OpenID"  Backstage##TabOpenID
"Register" "Register a TiddlySpace account" Backstage##TabRegister
>>

!TabOpenID
<<TiddlySpaceLogin openid>>

!TabRegister
<<TiddlySpaceRegister>>

!Options
upload a <<message messages.privacySetting>> file:
<<binaryUpload>>
<<search>><<closeAll>><<permaview>><<newTiddler>><<newJournal "DD MMM YYYY" "journal">><<saveChanges>><<slider chkSliderOptionsPanel OptionsPanel "options »" "Change TiddlyWiki advanced options">>

!Password
<<TiddlySpaceChangePassword>>

!SpaceInclusions
This space includes the public tiddlers from the following spaces:
<<TiddlySpaceInclusion list>>
<<TiddlySpaceInclusion passive>>

!SpaceMembers
The following people are members of the space ''<<message extensions.tiddlyspace.currentSpace.name>>''. Only members have access to the private tiddlers in a space.
<<TiddlySpaceMembers list>>
<<TiddlySpaceMembers add>>

!Tiddlers
<<tabs
	txtMainTab
	"Recent" "Recently edited tiddlers" TabTimeline
>>

!BatchOps
<<tabs
	txtPublisherTab
	"Private" "Move tiddlers from private to public" Backstage##BatchPrivate
	"Public" "Move tiddlers from public to private" Backstage##BatchPublic
>>

!BatchPrivate
<<TiddlySpacePublisher type:private>>

!BatchPublic
<<TiddlySpacePublisher type:public>>

!UserSpaces
<<TiddlySpaceSpaces add>>
You are currently a member of the following spaces.
{{inlineList{
<<TiddlySpaceSpaces list>>
}}}
{{backstageClear{}}}
/***
|''Name''|TiddlySpaceRevertRevision|
|''Description''|Revert to a previous revision|
|''Author''|BenGillies|
|''Version''|0.1|
|''Status''|unstable|
|''Source''|http://github.com/TiddlySpace/tiddlyspace|
|''CodeRepository''|http://github.com/TiddlySpace/tiddlyspace|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''CoreVersion''|2.6.0|
|''Requires''|TiddlyWebAdaptor TiddlySpaceRevisionView|
!Usage
Add a control button to revert to a particular revision.

The button must be called from within a revision, as generated by TiddlySpaceRevisionView
!Code
***/
//{{{
(function($) {

config.commands.revert = {
	text: "revert",
	tooltip: "make this revision the current one",
	handler: function(ev, src, title) {
		var revElem = story.getTiddler(title);
		var tidToRevert = store.getTiddler($(revElem).attr("revName"));

		var revision = store.getTiddler(title);
		if ((revision) && (tidToRevert)) {
			tidToRevert.text = revision.text;
			var newFields = merge({}, revision.fields);
			for (var fieldName in newFields) {
				if (fieldName.substr(0, 7) === "server.") {
					delete newFields[fieldName];
				}
			}
			merge(tidToRevert.fields, newFields);
			tidToRevert.tags = merge([], revision.tags);
			tidToRevert.fields.changecount = 1;
			delete tidToRevert.fields.doNotSave;

			store.saveTiddler(tidToRevert.title, tidToRevert.title,
				tidToRevert.text, null, null, tidToRevert.tags,
				tidToRevert.fields, false, tidToRevert.created, tidToRevert.creator);

			autoSaveChanges(true);
		}
	}
};

})(jQuery);
//}}}
<svg xmlns="http://www.w3.org/2000/svg" xmlns:xl="http://www.w3.org/1999/xlink" version="1.1" viewBox="2 724 68 55" 
width="30" height="30">
<g stroke="none" stroke-opacity="1" stroke-dasharray="none" fill="none" fill-opacity="1">
	<g>
		<path d="M 2.25 756 L 11.25 747 L 24.75 760.4994 L 60.750004 724.4994 L 69.75 733.49902 
		L 24.749977 778.49976 Z" fill="#101010" class="glyph"/>
	</g>
</g>
</svg>
5.2 Customer focus

Top management shall ensure that customer requirements are determined and are met (see 7.2.1 and 8.2.1).
Welcome to [[Dirk-Jan Swagerman's|http://nl.linkedin.com/in/djswagerman]] [[tiddlyspace|www.tiddlyspace.com]]. I host my own tiddlyspace for notekeeping and bookmarking on different subjects. The site is primairly aimed for my own use, infrequently i may [[blog|http://blog.dirkjanswagerman.nl]] on topics that may interest me. You can explore different subjects in the menu bar on top and in addition the following spaces may be of your interest:

* [[Mbi|http://mbi.dirkjanswagerman.nl]], study notes for my Master of Business Innovation study at ~Tias-Nimbas
* [[Sales|http://sales.dirkjanswagerman.nl]], summary of 3 books on sales, negotiation and influence.
* [[Games|http://games.dirkjanswagerman.nl]], started reading the book [[Gamestorming]]@games but extended with other games i stumbled upon
* [[Software|http://software.dirkjanswagerman.nl]], bookmarks on software
* [[Management|http://management.dirkjanswagerman.nl]], softskills and management bookmarks (for instance around [[DISC|http://disc.dirkjanswagerman.nl]] and [[Situational Leadership|http://situationalleadership.dirkjanswagerman.nl]]

From my time at Philips Healthcare:
* [[FDA Regulation|http://fda.dirkjanswagerman.nl]], my summary of FDA regulation for medical devices.

From my time at FEI:
* [[Microscopy|http://microscopy.dirkjanswagerman.nl]], lectures and bookmarks about microscopy.
* [[Nanotechnology|http://nanotechnology.dirkjanswagerman.nl]], bookmarks on nano tech in general

Please send me an [[email|mailto://dirkjan@dirkjanswagerman.nl]] if you feel i need to remove certain contents from the site due to copyright infringements.

!About this space
<<tiddler [[About this space]]>>

!About ~Dirk-Jan
<<tiddler [[About Dirk Jan]]>>

!How to use
This site is build as a [[tiddlywiki|http://www.tiddlywiki.com]] and hosted using [[tiddlyspace|http://www.tiddlyspace.com]] technololgy.  Reading ~TiddlyWikis is easy, but takes some getting used to. Rather than scrolling up and down a long web page or word processing document, you open small chunks of information ("microcontent") written in boxes called "tiddlers." You read what you need from a tiddler, then close it with the close button at the top right hand corner of the tiddler.

When a tiddler is opened up, it appears at the top of the screen or below the tiddler used to link to it. After opening a few tiddlers in succession, you might feel overwhelmed by all the open tiddlers. Not to worry.

* You can close every tiddler but the one you are using by clicking on the close others button.
* If you have multiple tiddlers open, you can use the jump button to quickly go to the open tiddler you desire without having to scroll up and down.
* See here for information on the other buttons at the top right of the tiddler.

To search for a tiddler, you can use the search window at the top right of the screen. All the tiddlers that contain the word that you search for will appear.  Use 'search' on (right of the screen) to find information on a topic, for instance:
* Search for M3 to find all notes taken during module '3'. Module numbers can be found at the left
* Search for 'Reading' to see abstract of articles
* Search for 'Session notes' to see notes taken during the training
Click on a module on the left to navigate to a certain module or module session.

!Log In
<<TiddlySpaceLogin>>
!Sign Up
<<TiddlySpaceRegister>>

!Log Out
<<TiddlySpaceLogout>>
A 510(k) is a [[Premarket notification]] in which a device manufacturer anounces to the FDA its intended introduction of a medical device.
|Symbol|Command|h
|$\large 2^{2}$|2^2|
|$\large \textstyle a_i$|a_i|
|$\large \textstyle 2^{23}	$|2^{23}|
|$\large \textstyle n_{i-1}	$|n_{i-1}|
|$\large a^{i+1}_3$|a^{i+1}_3|
|$\large x^{3^2}$|x^{3^2}|
|$\large 2^{a_i}$|2^{a_i}|
|$\large 2^a_i$|2^a_i|

Once you have some content then you may choose to determine a tiddler, or set of tiddlers to display each time you load ~TiddlySpace. This is determined by the [[DefaultTiddlers]].
<!DOCTYPE html>
<html>
<head>
	<meta http-equiv="Content-Type" content="text/html;charset=utf-8">
	<title>This Space</title>
	<link href="/bags/common/tiddlers/profile.css" type='text/css' rel='stylesheet' >
	<link href="/bags/common/tiddlers/admin.css" type='text/css' rel='stylesheet' >
	<!--[if lte IE 8]>
	<script type="text/javascript" src="/bags/common/tiddlers/json2.js"></script>
	<script type="text/javascript" src="/bags/common/tiddlers/es5-shim.min.js"></script>
	<![endif]-->
</head>
<body>
<div id="container">
	<div id="text-html" class="main section">
		<a class="app" href="/">home</a>
		<div class="left">
		<h2>About this space <button class='toggleNext'></button></h2>
		<div id="siteinfo"></div>
		<h2>Site Icon</h2>
		<div>
			<img id="siteicon" class="siteicon">
			<form id="upload" method="POST" enctype="multipart/form-data">
				<input type="hidden" name="title" value="SiteIcon" />
				<input type="hidden" name="tags" value="excludeLists">
				<input type="hidden" name="csrf_token" class="csrf" />
				<input type="file" name="file" accept="image/*" />
				<input class="btn" type="submit" value="upload" />
			</form>
			<div id="dropzone">Drop file here
				<img class="notloading" src="/bags/common/tiddlers/ajax-loader.gif" alt="submitting SiteIcon" />
			</div>
		</div>
		<h2>Vital Statistics</h2>
		<div id="info">please wait while information is loaded about this space...</div>
		<button class="spacereset">Reset Space</button>
		<div class="reset-confirm-wrap messageArea">
			<button class="close-btn" title="cancel reset">×</button>
			<p>Are you sure you want to reset the space? You can't go back! This will remove all the content from the space!</p>
			<form class="cf">
				<label for="reset-confirm">Enter the space name to confirm.</label>
				<input type="text" name="reset-confirm" class="reset-confirm-input inputBox" />
				<button type="submit">Reset Now</button>
			</form>
			<div class="reset-message-area">
				<p class="performing">Resetting...</p>
				<p class="finished">Reset Done!</p>
				<p class="recipe-error-msg">Error removing includes. Please remove manually.</p>
			</div>
		</div>
		</div>
		<div class="right">
		<div class="ts-membership">
			<h2>
				Add Member
				<a href="http://docs.tiddlyspace.com/What%20is%20a%20member%3F" title="What is a Member?" class="help">What is a Member?</a>
			</h2>
			<div>
				<p>Add a new member to your space by entering their name below. Enter a space name instead and prefix with @ to add everyone who is already a member of that space.</p>
				<form class="ts-members">
					<input class="inputBox" type="text" name="username">
					<input type="submit" value="Add Member" class="btn" />
				</form>
			</div>
			<h2>
				Existing Members <button class='toggleNext'></button>
			</h2>
			<div>
				Your space currently has the following members: 
				<ul class="ts-members"></ul>
			</div>
			<h2>
				Include Space
				<a class="help" href="http://docs.tiddlyspace.com/What%20is%20space%20inclusion%3F" title="What is inclusion?">What is Inclusion?</a>
			</h2>
			<form class="ts-includes">
				<input class="inputBox" type="text" name="spacename">
				<input type="submit" value="Include Space" class="btn" />
			</form>
		</div>
		<div>
			<h2>Included Spaces <button class='toggleNext'></button></h2>
			<div>
			This space includes the following spaces:
			<ul class="ts-includes"></ul>
			</div>
		</div>
		</div>
		<div class="clear"></div>
	</div>
</div>
<script src='/bags/common/tiddlers/backstage.js'></script>
<script src='/bags/common/tiddlers/jquery.js'></script>
<script src='/bags/tiddlyspace/tiddlers/chrjs'></script>
<script src='/bags/common/tiddlers/chrjs.space'></script>
<script src='/bags/common/tiddlers/chrjs.users'></script>
<script src='/bags/common/tiddlers/chrjs.identities'></script>
<script src='/bags/tiddlyspace/tiddlers/TiddlySpaceCSRF'></script>
<script src='/bags/common/tiddlers/jquery-form.js'></script>
<script src="/bags/common/tiddlers/siteiconupload.js"></script>
<script src="/bags/common/tiddlers/ts.js"></script>
<script src="/status.js"></script>
<script src="/bags/common/tiddlers/space.js"></script>
</body>
</html>
//(3) Non-image-intensified fluoroscopy//
The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. Means shall be provided for stepless adjustment of field size. The minimum field size, at the greatest SID, shall be containable in a square of 5 cm by 5 cm.
In FDA Regulations there are three types of device:
<<image /static/files/FDA/Device%20Classification.jpg width:600>>
!Class I Medical Devices
<<tiddler [[Class I Medical Devices]]>>

!Class II Medical Devices
<<tiddler [[Class II Medical Devices]]>>

!Class III Medical Devices
<<tiddler [[Class III Medical Devices]]>>

<<image /static/files/FDA/Device%20Classification%20Workflow.jpg width:600>>

Source(s):
http://www.ece.uc.edu/POC-CENT/funding/Additional%20Information/fda-classification
The management control flow chart indicates which steps may be taken during [[FDA Inspection]]
<<image /static/files/FDA/ManagementControlFlowChart.jpg width:600>>
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] the ''//Medical Device Report//'' (MDR) means Medical Device Reporting. To be elaborated...
/***
|''Name''|TiddlySpaceCloneCommand|
|''Version''|0.5.8|
|''Description''|provides a toolbar command for cloning external tiddlers|
|''Status''|stable|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/TiddlySpaceCloneCommand.js|
|''Requires''|TiddlySpaceConfig TiddlySpaceFilters|
!Code
***/
//{{{
(function($) {

var cmd = config.commands;
var tiddlyspace = config.extensions.tiddlyspace;

var fieldsCache = {};

cmd.cloneTiddler = {
	text: cmd.editTiddler.text,
	tooltip: "Create a copy of this tiddler in the current space",
	errorMsg: "Error publishing %0: %1",

	isEnabled: function(tiddler) {
		return !config.filterHelpers.is.local(tiddler) && !readOnly;
	},
	handler: function(ev, src, title) {
		var tiddler = store.getTiddler(title);
		if(tiddler) {
			fieldsCache[title] = $.extend({}, tiddler.fields);
			tiddler.fields["server.workspace"] = tiddlyspace.getCurrentWorkspace(config.options.chkPrivateMode ?
		"private" : "public");
			tiddler.fields["server.permissions"] = "read, write, create"; // no delete
			delete tiddler.fields["server.page.revision"];
			delete tiddler.fields["server.title"];
			delete tiddler.fields["server.etag"];
			// special handling for pseudo-shadow tiddlers
			if(tiddlyspace.coreBags.contains(tiddler.fields["server.bag"])) {
				tiddler.tags.remove("excludeLists");
			}
		} else { // ensure workspace is the current space
			var el = story.findContainingTiddler(src);
			el = $(el);
			var fields = el.attr("tiddlyfields");
			if(fields) { // inherited via TiddlyLink
				fields = fields.decodeHashMap();
				fields["server.workspace"] = config.
					defaultCustomFields["server.workspace"];
			} else {
				fields = config.defaultCustomFields;
			}
			fields = String.encodeHashMap(fields);
			el.attr("tiddlyfields", fields);
		}
		cmd.editTiddler.handler.apply(this, arguments);
		if(tiddler) {
			tiddler.fields["server.permissions"] += ", delete";
		}
		return false;
	}
};

cmd.editTiddler.isEnabled = function(tiddler) {
	return !cmd.cloneTiddler.isEnabled.apply(this, arguments);
};

// hijack cancelTiddler to restore original fields
var _cancelHandler = cmd.cancelTiddler.handler;
cmd.cancelTiddler.handler = function(ev, src, title) {
	var tiddler = store.getTiddler(title);
	if(tiddler) {
		tiddler.fields = fieldsCache[title] || tiddler.fields;
		delete fieldsCache[title];
	}
	return _cancelHandler.apply(this, arguments);
};

// hijack saveTiddler to clear unused fields stash
var _saveHandler = cmd.saveTiddler.handler;
cmd.saveTiddler.handler =  function(ev, src, title) {
	delete fieldsCache[title];
	return _saveHandler.apply(this, arguments);
};

})(jQuery);
//}}}
Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of an electrical medical equipment in many countries.[1] Many companies view compliance with IEC 60601-1 as a requirement for most markets.


http://en.wikipedia.org/wiki/IEC_60601
<<forEachTiddler
    where 
        '!tiddler.tags.contains("excludeLists")'
    sortBy 
        'tiddler.modified' descending
    
    script
        '
        function getGroupCaption(tiddler) {
            return tiddler.modified.formatString("DD MMM YYYY");
        } 

        function getGroupTitle(tiddler, context) {
            if (!context.lastGroup || context.lastGroup != getGroupCaption(tiddler)) {
                context.lastGroup = getGroupCaption(tiddler); 
                return "!!!" + (context.lastGroup?context.lastGroup:"no tags")+"\n";
            } else 
                return "";
        }
        '
    
    write
         '(index < 1000) ? getGroupTitle(tiddler, context)+"[[" + tiddler.title +"]]\n" : ""'
>>
In the FDA's Quality System Requirements ''Quality'' means the totality of features and characteristics tha bear on the ability of a device to satisfy fitness for use, including safety and performance.
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Design Input//'' means the physicla and performance requirements of a device that are used as a basis for device design.
/***
|''Name''|RefreshTiddlerCommand|
|''Version''|0.3.0|
***/
//{{{
(function($) {

var cmd = config.commands.refreshTiddler = {
	text: "refresh",
	locale: {
		refreshing: "Refreshing tiddler..."
	},
	tooltip: "refresh this tiddler to be the one on the server",
	handler: function(ev, src, title) {
		var tiddler = store.getTiddler(title);
		if(!tiddler) {
			tiddler = new Tiddler(title);
			merge(tiddler.fields, config.defaultCustomFields);
		}
		$(story.getTiddler(title)).find(".viewer").
			empty().text(cmd.locale.refreshing);
		var dirtyStatus = store.isDirty();
		story.loadMissingTiddler(title, {
			"server.workspace": tiddler.fields["server.recipe"]  ? "recipes/" + tiddler.fields["server.recipe"] :
				tiddler.fields["server.workspace"] || "bags/"+tiddler.fields["server.bag"],
			"server.host": tiddler.fields["server.host"],
			"server.type": tiddler.fields["server.type"]
		}, function() {
			store.setDirty(dirtyStatus);
		});
	}
};

})(jQuery);
//}}}
//(g) Source-skin distance//

* (1) Means shall be provided to limit the source-skin distance to
** not less than 38 cm on //stationary// fluoroscopes and to 
** not less than 30 cm on //mobile and portable// fluoroscopes.
** In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, //provisions may be made// for operation at shorter source-skin distances but in //''no case less than 20 cm''//. When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in 1020.30(h).

* (2) For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm. When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in 1020.30(h).
<!--{{{-->
<div class='toolbar'
	macro='toolbar [[ToolbarCommands::ViewToolbar]] icons:yes height:16 width:16 more:popup'>
</div>
<div class='heading'>
	<span class='spaceSiteIcon'
		macro='tiddlerOrigin label:no spaceLink:yes height:48 width:48 preserveAspectRatio:yes'>
	</span>
	<span class="titleBar">
		<div class='title' macro='view title text'></div>
		<span class="subtitle" macro='viewRevisions page:5'>
			last modified on
			<span macro="view modified date"></span>
		</span>
	</span>
	<div class='tagClear'></div>
</div>
<div class='content'>
	<div class='viewer' macro='view text wikified'></div>
</div>
<div class='tagInfo'>
	<div class='tidTags' macro='tags'></div>
	<div class='tagging' macro='tagging'></div>
        <div class='counted' macro='BBClonePlugin'></div>
</div>
<!--}}}-->
The Quality System Inspection Technique (QSIT) provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer's compliance with the Quality System Regulation and related regulations. Field investigators may conduct an efficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm's quality system.

The QSIT involves four [[Top-Down Inspection]]'s of the four major subsystems of the quality system:
* [[Manufacturing Controls]]
* [[Design Controls]]
* [[Corrective and Preventive actions]]
* [[Production and Process Controls]]

The QSIT (Quality System Inspection Technique) Handbook (copy available [[here|/static/files/FDA/QSIT_Inspection_handbook.pdf]]) is used to train FDA inspectiors in this technique.

Find the FDA description [[here|http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm]]
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<!DOCTYPE html>
<html lang="en">
<head>
	<meta charset="UTF-8">
	<meta http-equiv="X-UA-Compatible" content="IE=edge,chrome=1">
	<title>Reply</title>
	<link rel="stylesheet" href="//tiddlyspace.com/bags/benspa_public/tiddlers/bootvelcro.css">
	<style>
		html,
		body {
			overflow: hidden;
			background-color: transparent;
		}

		#container {
			/* prevent a fouc if no images present */
			display: none;
		}

		.modal-header {
			border-bottom: none;
			padding: 5px 0 0;
			position: absolute;
			width: 100%;
			background-color: #e0e0e0;
			-webkit-border-radius: 6px 6px 0 0;
			-moz-border-radius: 6px 6px 0 0;
			border-radius: 6px 6px 0 0;
			cursor: move;
		}

		.form-actions {
			position: absolute;
			bottom: 0;
			box-sizing: border-box;
			-moz-box-sizing: border-box;
			width: 100%;
			margin: 0;
			border-radius: 0 0 6px 6px;
			background-color: #e0e0e0;
			border-top: 1px solid gray;
		}

		.form-actions input.btn {
			width: auto;
			float: right;
			margin: 0 0.2em;
		}

		.closeBtn {
			background-color: #DCE7F1 !important;
		}

		.primary {
			background-color: #09F !important;
		}

		h1 {
			margin-bottom: 9px;
			margin-top: 9px;
		}

		body {
			width: 100%;
			height: 100%;
			position: absolute;
		}

		.modal {
			margin: 10px;
			top: 0;
			left: 0;
			bottom: 0;
			width: 510px;
			position: absolute;
			box-shadow: #444 0px 0px 10px 2px;
			border-radius: 6px;
			background-color: white;
			border: 1px solid gray;
			background-color: #F0F4F8;
		}

		label em {
			cursor: pointer;
		}

		.modal-body {
			overflow: auto;
			position: absolute;
			top: 0;
			bottom: 0;
			left: 0;
			right: 0;
			margin: 65px 20px 67px;
			background-color: transparent;
		}

		.nav-tabs {
			padding-left: 1%;
			margin: 0;
			width: 99%;
			border-color: gray;
		}

		.nav-tabs > li {
			cursor: pointer;
		}

		.nav-tabs > li > a {
			line-height: 2.4em;
			font-weight: bold;
			font-size: 100%;
		}

		.nav-tabs > li.active > a{
			background-color: #F0F4F8;
			border-color: gray;
			border-bottom-color: #F0F4F8;
		}

		.active {
			display: block;
		}

		input,
		textarea,
		select,
		.uneditable-input {
			color: #606060;
		}

		.imagePicker {
			-moz-box-shadow: inset 0 1px 3px rgba(0, 0, 0, 0.1);
			-webkit-box-shadow: inset 0 1px 3px rgba(0, 0, 0, 0.1);
			box-shadow: inset 0 1px 3px rgba(0, 0, 0, 0.1);
			border: 1px solid #CCC;
			height: 110px;
			overflow: auto;
			-webkit-border-radius: 3px;
			-moz-border-radius: 3px;
			border-radius: 3px;
			margin-left: 0;
		}

		.imagePicker img {
			margin: 5px;
			border: 2px solid transparent;
		}

		.imagePicker .current {
			border: 2px dotted #555;
		}

		label {
			font-weight: bold;
		}

		.form-actions label {
			float: left;
			margin-top: 0.75em;
		}

		fieldset input,
		fieldset textarea {
			width: 90%;
			border-color: gray;
		}

		@media all and (max-width: 550px) {
			.modal {
				width: 95%;
			}
		}

		#help {
			position: absolute;
			border: 0;
			right: 4px;
			top: 5px;
			text-indent: -9999px;
			color: transparent;
			height: 16px;
			width: 16px;
			background: none;
			background-image: url(/bags/common/tiddlers/help.png);
			background-repeat: no-repeat;
			background-color: white;
			z-index: 2;
			border-radius: 10px;
		}

		#help-info {
			padding: 0;
			border: 1px solid gray;
			width: 60%;
			height: 50px;
			color: #404040;
			background-color: white;
			position: absolute;
			top: 5px;
			right: 5px;
			z-index: 1;
			cursor: auto;
			border-radius: 5px;

		}

		#help-info p {
			padding: 10px 25px;
			margin-bottom: 0;
		}
	</style>
</head>
<body>
	<div id="container">
		<form action="#" class="modal">
			<div class="modal-header">
				<button id="help">help</button>
				<div id="help-info" style="display:none;"><p>
				Found something interesting? Write about it in your own space. <a href="//docs.tiddlyspace.com/Reply to this Tiddler" target="_blank">Find out more</a>
				</p></div>
				<ul class="nav nav-tabs" data-tabs="tabs">
					<li class="active" data-tab-name="post"><a href="#postForm">Reply</a></li>
				</ul>
			</div>


			<fieldset id="postForm" class="modal-body">
				<label>Title
					<input type="text" name="title">
				</label>
				<input type="hidden" name="url">
				<label>Post
					<textarea name="text" rows="8"></textarea>
				</label>
				<label>Tags
					<input type="text" name="tags" value="">
				</label>
			</fieldset>


			<div class="form-actions">
				<label class="checkbox">
					<input type="checkbox" name="private" val="private">
					keep private
				</label>
				<input type="submit" class="btn primary btn-large" value="Done">
				<input type="button" class="btn btn-large closeBtn" value="Cancel">
			</div>
		</form>
	</div>

	<script type="text/javascript"
            src="/bags/common/tiddlers/jquery.js"></script>
	<script type="text/javascript" src="/bags/tiddlyspace/tiddlers/chrjs"></script>
	<script type="text/javascript" src="/bags/common/tiddlers/_reply.js"></script>
</body>
</html>
A ''Directed Inspection'' is an inspection performed on specific elements of a firm's quality system subject to FDA jurisdiction, as identified by agency manuals, assignments, or officials to assess those elements compliance staus or technological characteristics
The CFR regulations described with respect to Personnel are:
<<forEachTiddler
    where
        'tiddler.tags.contains("CFR 21-820.25")'
    sortBy 
         'tiddler.title.toUpperCase()'
   write
         '"* [["+tiddler.title+"]]" + "\n"'

>>

!FDA Inspection

During inspection attention points will be:
* If procedures identifying training needs exist
* Review all training records to ensure that training is documented and being conducted
* Verify if employees are made aware of defects and errors that may occur if they fail to perform their job.
* Verify that quality personnel have been made aware of defects and errors thaht may occuring during bad perfomance in their job.
/***
|''Name''|TiddlyWebAdaptor|
|''Description''|adaptor for interacting with TiddlyWeb|
|''Author:''|FND|
|''Contributors''|Chris Dent, Martin Budden|
|''Version''|1.4.10|
|''Status''|stable|
|''Source''|http://svn.tiddlywiki.org/Trunk/association/adaptors/TiddlyWebAdaptor.js|
|''CodeRepository''|http://svn.tiddlywiki.org/Trunk/association/|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''CoreVersion''|2.5|
|''Keywords''|serverSide TiddlyWeb|
!Notes
This plugin includes [[jQuery JSON|http://code.google.com/p/jquery-json/]].
!To Do
* createWorkspace
* document custom/optional context attributes (e.g. filters, query, revision) and tiddler fields (e.g. server.title, origin)
!Code
***/
//{{{
(function($) {

var adaptor = config.adaptors.tiddlyweb = function() {};

adaptor.prototype = new AdaptorBase();
adaptor.serverType = "tiddlyweb";
adaptor.serverLabel = "TiddlyWeb";
adaptor.mimeType = "application/json";

adaptor.parsingErrorMessage = "Error parsing result from server";
adaptor.noBagErrorMessage = "no bag specified for tiddler";
adaptor.locationIDErrorMessage = "no bag or recipe specified for tiddler"; // TODO: rename

// retrieve current status (requires TiddlyWeb status plugin)
adaptor.prototype.getStatus = function(context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	var uriTemplate = "%0/status";
	var uri = uriTemplate.format([context.host]);
	var req = httpReq("GET", uri, adaptor.getStatusCallback, context,
		null, null, null, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.getStatusCallback = function(status, context, responseText, uri, xhr) {
	context.status = responseText ? status : false;
	try {
		context.statusText = xhr.statusText;
	} catch(exc) { // offline (Firefox)
		context.status = false;
		context.statusText = null;
	}
	context.httpStatus = xhr.status;
	if(context.status) {
		context.serverStatus = $.evalJSON(responseText); // XXX: error handling!?
	}
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// retrieve a list of workspaces
adaptor.prototype.getWorkspaceList = function(context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	context.workspaces = [];
	var uriTemplate = "%0/recipes"; // XXX: bags?
	var uri = uriTemplate.format([context.host]);
	var req = httpReq("GET", uri, adaptor.getWorkspaceListCallback,
		context, { accept: adaptor.mimeType }, null, null, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.getWorkspaceListCallback = function(status, context, responseText, uri, xhr) {
	context.status = status;
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(status) {
		try {
			var workspaces = $.evalJSON(responseText);
		} catch(ex) {
			context.status = false; // XXX: correct?
			context.statusText = exceptionText(ex, adaptor.parsingErrorMessage);
			if(context.callback) {
				context.callback(context, context.userParams);
			}
			return;
		}
		context.workspaces = workspaces.map(function(itm) { return { title: itm }; });
	}
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// retrieve a list of tiddlers
adaptor.prototype.getTiddlerList = function(context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	var uriTemplate = "%0/%1/%2/tiddlers%3";
	var params = context.filters ? "?" + context.filters : "";
	if(context.format) {
		params = context.format + params;
	}
	var workspace = adaptor.resolveWorkspace(context.workspace);
	var uri = uriTemplate.format([context.host, workspace.type + "s",
		adaptor.normalizeTitle(workspace.name), params]);
	var req = httpReq("GET", uri, adaptor.getTiddlerListCallback,
		context, merge({ accept: adaptor.mimeType }, context.headers), null, null, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.getTiddlerListCallback = function(status, context, responseText, uri, xhr) {
	context.status = status;
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(status) {
		context.tiddlers = [];
		try {
			var tiddlers = $.evalJSON(responseText); //# NB: not actual tiddler instances
		} catch(ex) {
			context.status = false; // XXX: correct?
			context.statusText = exceptionText(ex, adaptor.parsingErrorMessage);
			if(context.callback) {
				context.callback(context, context.userParams);
			}
			return;
		}
		for(var i = 0; i < tiddlers.length; i++) {
			var tiddler = adaptor.toTiddler(tiddlers[i], context.host);
			context.tiddlers.push(tiddler);
		}
	}
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// perform global search
adaptor.prototype.getSearchResults = function(context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	var uriTemplate = "%0/search?q=%1%2";
	var filterString = context.filters ? ";" + context.filters : "";
	var uri = uriTemplate.format([context.host, context.query, filterString]); // XXX: parameters need escaping?
	var req = httpReq("GET", uri, adaptor.getSearchResultsCallback,
		context, { accept: adaptor.mimeType }, null, null, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.getSearchResultsCallback = function(status, context, responseText, uri, xhr) {
	adaptor.getTiddlerListCallback(status, context, responseText, uri, xhr); // XXX: use apply?
};

// retrieve a particular tiddler's revisions
adaptor.prototype.getTiddlerRevisionList = function(title, limit, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	var uriTemplate = "%0/%1/%2/tiddlers/%3/revisions";
	var workspace = adaptor.resolveWorkspace(context.workspace);
	var uri = uriTemplate.format([context.host, workspace.type + "s",
		adaptor.normalizeTitle(workspace.name), adaptor.normalizeTitle(title)]);
	var req = httpReq("GET", uri, adaptor.getTiddlerRevisionListCallback,
		context, merge({ accept: adaptor.mimeType }, context.headers), null, null, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.getTiddlerRevisionListCallback = function(status, context, responseText, uri, xhr) {
	context.status = status;
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(status) {
		context.revisions = [];
		try {
			var tiddlers = $.evalJSON(responseText); //# NB: not actual tiddler instances
		} catch(ex) {
			context.status = false; // XXX: correct?
			context.statusText = exceptionText(ex, adaptor.parsingErrorMessage);
			if(context.callback) {
				context.callback(context, context.userParams);
			}
			return;
		}
		for(var i = 0; i < tiddlers.length; i++) {
			var tiddler = adaptor.toTiddler(tiddlers[i], context.host);
			context.revisions.push(tiddler);
		}
		var sortField = "server.page.revision";
		context.revisions.sort(function(a, b) {
			return a.fields[sortField] < b.fields[sortField] ? 1 :
				(a.fields[sortField] == b.fields[sortField] ? 0 : -1);
		});
	}
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// retrieve an individual tiddler revision -- XXX: breaks with standard arguments list -- XXX: convenience function; simply use getTiddler?
adaptor.prototype.getTiddlerRevision = function(title, revision, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	context.revision = revision;
	return this.getTiddler(title, context, userParams, callback);
};

// retrieve an individual tiddler
//# context is an object with members host and workspace
//# callback is passed the new context and userParams
adaptor.prototype.getTiddler = function(title, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	context.title = title;
	if(context.revision) {
		var uriTemplate = "%0/%1/%2/tiddlers/%3/revisions/%4";
	} else {
		uriTemplate = "%0/%1/%2/tiddlers/%3";
	}
	if(!context.tiddler) {
		context.tiddler = new Tiddler(title);
	}
	context.tiddler.fields["server.type"] = adaptor.serverType;
	context.tiddler.fields["server.host"] = AdaptorBase.minHostName(context.host);
	context.tiddler.fields["server.workspace"] = context.workspace;
	var workspace = adaptor.resolveWorkspace(context.workspace);
	var uri = uriTemplate.format([context.host, workspace.type + "s",
		adaptor.normalizeTitle(workspace.name), adaptor.normalizeTitle(title),
		context.revision]);
	var req = httpReq("GET", uri, adaptor.getTiddlerCallback, context,
		merge({ accept: adaptor.mimeType }, context.headers), null, null, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.getTiddlerCallback = function(status, context, responseText, uri, xhr) {
	context.status = status;
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(status) {
		try {
			var tid = $.evalJSON(responseText);
		} catch(ex) {
			context.status = false;
			context.statusText = exceptionText(ex, adaptor.parsingErrorMessage);
			if(context.callback) {
				context.callback(context, context.userParams);
			}
			return;
		}
		var tiddler = adaptor.toTiddler(tid, context.host);
		tiddler.title = context.tiddler.title;
		tiddler.fields["server.etag"] = xhr.getResponseHeader("Etag");
		// normally we'd assign context.tiddler = tiddler here - but we can't do
		// that because of IE, which triggers getTiddler in putTiddlerCallback,
		// and since ServerSideSavingPlugin foolishly relies on persistent
		// object references, we need to merge the data into the existing object
		$.extend(context.tiddler, tiddler);
	}
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// retrieve tiddler chronicle (all revisions)
adaptor.prototype.getTiddlerChronicle = function(title, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	context.title = title;
	var uriTemplate = "%0/%1/%2/tiddlers/%3/revisions?fat=1";
	var workspace = adaptor.resolveWorkspace(context.workspace);
	var uri = uriTemplate.format([context.host, workspace.type + "s",
		adaptor.normalizeTitle(workspace.name), adaptor.normalizeTitle(title)]);
	var req = httpReq("GET", uri, adaptor.getTiddlerChronicleCallback,
		context, { accept: adaptor.mimeType }, null, null, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.getTiddlerChronicleCallback = function(status, context, responseText, uri, xhr) {
	context.status = status;
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(status) {
		context.responseText = responseText;
	}
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// store an individual tiddler
adaptor.prototype.putTiddler = function(tiddler, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	context.title = tiddler.title;
	context.tiddler = tiddler;
	context.host = context.host || this.fullHostName(tiddler.fields["server.host"]);
	var uriTemplate = "%0/%1/%2/tiddlers/%3";
	try {
		context.workspace = context.workspace || tiddler.fields["server.workspace"];
		var workspace = adaptor.resolveWorkspace(context.workspace);
	} catch(ex) {
		return adaptor.locationIDErrorMessage;
	}
	var uri = uriTemplate.format([context.host, workspace.type + "s",
		adaptor.normalizeTitle(workspace.name),
		adaptor.normalizeTitle(tiddler.title)]);
	var etag = adaptor.generateETag(workspace, tiddler);
	var headers = etag ? { "If-Match": etag } : null;
	var payload = {
		type: tiddler.fields["server.content-type"] || null,
		text: tiddler.text,
		tags: tiddler.tags,
		fields: $.extend({}, tiddler.fields)
	};
	delete payload.fields.changecount;
	$.each(payload.fields, function(key, value) {
		if(key.indexOf("server.") == 0) {
			delete payload.fields[key];
		}
	});
	payload = $.toJSON(payload);
	var req = httpReq("PUT", uri, adaptor.putTiddlerCallback,
		context, headers, payload, adaptor.mimeType, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.putTiddlerCallback = function(status, context, responseText, uri, xhr) {
	context.status = [204, 1223].contains(xhr.status);
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(context.status) {
		var loc = xhr.getResponseHeader("Location");
		var etag = xhr.getResponseHeader("Etag");
		if(loc && etag) {
			var bag = loc.split("/bags/").pop().split("/")[0];
			context.tiddler.fields["server.bag"] = bag;
			context.tiddler.fields["server.workspace"] = "bags/" + bag;
			var rev = etag.split("/").pop().split(/;|:/)[0];
			context.tiddler.fields["server.page.revision"] = rev;
			context.tiddler.fields["server.etag"] = etag;
			if(context.callback) {
				context.callback(context, context.userParams);
			}
		} else { // IE
			context.adaptor.getTiddler(context.tiddler.title, context,
				context.userParams, context.callback);
		}
	} else if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// store a tiddler chronicle
adaptor.prototype.putTiddlerChronicle = function(revisions, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	context.title = revisions[0].title;
	var headers = null;
	var uriTemplate = "%0/%1/%2/tiddlers/%3/revisions";
	var host = context.host || this.fullHostName(tiddler.fields["server.host"]);
	var workspace = adaptor.resolveWorkspace(context.workspace);
	var uri = uriTemplate.format([host, workspace.type + "s",
		adaptor.normalizeTitle(workspace.name),
		adaptor.normalizeTitle(context.title)]);
	if(workspace.type == "bag") { // generate ETag
		var etag = [adaptor.normalizeTitle(workspace.name),
			adaptor.normalizeTitle(context.title), 0].join("/"); //# zero-revision prevents overwriting existing contents
		headers = { "If-Match": '"' + etag + '"' };
	}
	var payload = $.toJSON(revisions);
	var req = httpReq("POST", uri, adaptor.putTiddlerChronicleCallback,
		context, headers, payload, adaptor.mimeType, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.putTiddlerChronicleCallback = function(status, context, responseText, uri, xhr) {
	context.status = [204, 1223].contains(xhr.status);
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// store a collection of tiddlers (import TiddlyWiki HTML store)
adaptor.prototype.putTiddlerStore = function(store, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	var uriTemplate = "%0/%1/%2/tiddlers";
	var host = context.host;
	var workspace = adaptor.resolveWorkspace(context.workspace);
	var uri = uriTemplate.format([host, workspace.type + "s",
		adaptor.normalizeTitle(workspace.name)]);
	var req = httpReq("POST", uri, adaptor.putTiddlerStoreCallback,
		context, null, store, "text/x-tiddlywiki", null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.putTiddlerStoreCallback = function(status, context, responseText, uri, xhr) {
	context.status = [204, 1223].contains(xhr.status);
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// rename an individual tiddler or move it to a different workspace -- TODO: make {from|to}.title optional
//# from and to are objects with members title and workspace (bag; optional),
//# representing source and target tiddler, respectively
adaptor.prototype.moveTiddler = function(from, to, context, userParams, callback) { // XXX: rename parameters (old/new)?
	var self = this;
	var newTiddler = store.getTiddler(from.title) || store.getTiddler(to.title); //# local rename might already have occurred
	var oldTiddler = $.extend(true, {}, newTiddler); //# required for eventual deletion
	oldTiddler.title = from.title; //# required for original tiddler's ETag
	var _getTiddlerChronicle = function(title, context, userParams, callback) {
		return self.getTiddlerChronicle(title, context, userParams, callback);
	};
	var _putTiddlerChronicle = function(context, userParams) {
		if(!context.status) {
			return callback(context, userParams);
		}
		var revisions = $.evalJSON(context.responseText); // XXX: error handling?
		// change current title while retaining previous location
		for(var i = 0; i < revisions.length; i++) {
			delete revisions[i].revision;
			if(!revisions[i].fields.origin) { // NB: origin = "<workspace>/<title>"
				revisions[i].fields.origin = ["bags", revisions[i].bag, revisions[i].title].join("/");
			}
			revisions[i].title = to.title;
		}
		// add new revision
		var rev = $.extend({}, revisions[0]);
		$.each(newTiddler, function(i, item) {
			if(!$.isFunction(item)) {
				rev[i] = item;
			}
		});
		rev.title = to.title;
		rev.created = rev.created.convertToYYYYMMDDHHMM();
		rev.modified = new Date().convertToYYYYMMDDHHMM();
		delete rev.fields.changecount;
		revisions.unshift(rev);
		if(to.workspace) {
			context.workspace = to.workspace;
		} else if(context.workspace.substring(0, 4) != "bags") { // NB: target workspace must be a bag
			context.workspace = "bags/" + rev.bag;
		}
		var subCallback = function(context, userParams) {
			if(!context.status) {
				return callback(context, userParams);
			}
			context.adaptor.getTiddler(newTiddler.title, context, userParams, _deleteTiddler);
		};
		return self.putTiddlerChronicle(revisions, context, context.userParams, subCallback);
	};
	var _deleteTiddler = function(context, userParams) {
		if(!context.status) {
			return callback(context, userParams);
		}
		$.extend(true, newTiddler, context.tiddler);
		context.callback = null;
		return self.deleteTiddler(oldTiddler, context, context.userParams, callback);
	};
	callback = callback || function() {};
	context = this.setContext(context, userParams);
	context.host = context.host || oldTiddler.fields["server.host"];
	context.workspace = from.workspace || oldTiddler.fields["server.workspace"];
	return _getTiddlerChronicle(from.title, context, userParams, _putTiddlerChronicle);
};

// delete an individual tiddler
adaptor.prototype.deleteTiddler = function(tiddler, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	context.title = tiddler.title; // XXX: not required!?
	var uriTemplate = "%0/bags/%1/tiddlers/%2";
	var host = context.host || this.fullHostName(tiddler.fields["server.host"]);
	var bag = tiddler.fields["server.bag"];
	if(!bag) {
		return adaptor.noBagErrorMessage;
	}
	var uri = uriTemplate.format([host, adaptor.normalizeTitle(bag),
		adaptor.normalizeTitle(tiddler.title)]);
	var etag = adaptor.generateETag({ type: "bag", name: bag }, tiddler);
	var headers = etag ? { "If-Match": etag } : null;
	var req = httpReq("DELETE", uri, adaptor.deleteTiddlerCallback, context, headers,
		null, null, null, null, true);
	return typeof req == "string" ? req : true;
};

adaptor.deleteTiddlerCallback = function(status, context, responseText, uri, xhr) {
	context.status = [204, 1223].contains(xhr.status);
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// compare two revisions of a tiddler (requires TiddlyWeb differ plugin)
//# if context.rev1 is not specified, the latest revision will be used for comparison
//# if context.rev2 is not specified, the local revision will be sent for comparison
//# context.format is a string as determined by the TiddlyWeb differ plugin
adaptor.prototype.getTiddlerDiff = function(title, context, userParams, callback) {
	context = this.setContext(context, userParams, callback);
	context.title = title;

	var tiddler = store.getTiddler(title);
	try {
		var workspace = adaptor.resolveWorkspace(tiddler.fields["server.workspace"]);
	} catch(ex) {
		return adaptor.locationIDErrorMessage;
	}
	var tiddlerRef = [workspace.type + "s", workspace.name, tiddler.title].join("/");

	var rev1 = context.rev1 ? [tiddlerRef, context.rev1].join("/") : tiddlerRef;
	var rev2 = context.rev2 ? [tiddlerRef, context.rev2].join("/") : null;

	var uriTemplate = "%0/diff?rev1=%1";
	if(rev2) {
		uriTemplate += "&rev2=%2";
	}
	if(context.format) {
		uriTemplate += "&format=%3";
	}
	var host = context.host || this.fullHostName(tiddler.fields["server.host"]);
	var uri = uriTemplate.format([host, adaptor.normalizeTitle(rev1),
		adaptor.normalizeTitle(rev2), context.format]);

	if(rev2) {
		var req = httpReq("GET", uri, adaptor.getTiddlerDiffCallback, context, null,
			null, null, null, null, true);
	} else {
		var payload = {
			title: tiddler.title,
			text: tiddler.text,
			modifier: tiddler.modifier,
			tags: tiddler.tags,
			fields: $.extend({}, tiddler.fields)
		}; // XXX: missing attributes!?
		payload = $.toJSON(payload);
		req = httpReq("POST", uri, adaptor.getTiddlerDiffCallback, context,
			null, payload, adaptor.mimeType, null, null, true);
	}
	return typeof req == "string" ? req : true;
};

adaptor.getTiddlerDiffCallback = function(status, context, responseText, uri, xhr) {
	context.status = status;
	context.statusText = xhr.statusText;
	context.httpStatus = xhr.status;
	context.uri = uri;
	if(status) {
		context.diff = responseText;
	}
	if(context.callback) {
		context.callback(context, context.userParams);
	}
};

// generate tiddler information
adaptor.prototype.generateTiddlerInfo = function(tiddler) {
	var info = {};
	var uriTemplate = "%0/%1/%2/tiddlers/%3";
	var host = this.host || tiddler.fields["server.host"]; // XXX: this.host obsolete?
	host = this.fullHostName(host);
	var workspace = adaptor.resolveWorkspace(tiddler.fields["server.workspace"]);
	info.uri = uriTemplate.format([host, workspace.type + "s",
		adaptor.normalizeTitle(workspace.name),
		adaptor.normalizeTitle(tiddler.title)]);
	return info;
};

// create Tiddler instance from TiddlyWeb tiddler JSON
adaptor.toTiddler = function(json, host) {
	var created = Date.convertFromYYYYMMDDHHMM(json.created);
	var modified = Date.convertFromYYYYMMDDHHMM(json.modified);
	var fields = json.fields;
	fields["server.type"] = adaptor.serverType;
	fields["server.host"] = AdaptorBase.minHostName(host);
	fields["server.bag"] = json.bag;
	fields["server.title"] = json.title;
	if(json.recipe) {
		fields["server.recipe"] = json.recipe;
	}
	if(json.type && json.type != "None") {
		fields["server.content-type"] = json.type;
	}
	fields["server.permissions"] = json.permissions.join(", ");
	fields["server.page.revision"] = json.revision;
	fields["server.workspace"] = "bags/" + json.bag;
	var tiddler = new Tiddler(json.title);
	tiddler.assign(tiddler.title, json.text, json.modifier, modified, json.tags,
		created, json.fields, json.creator);
	return tiddler;
};

adaptor.resolveWorkspace = function(workspace) {
	var components = workspace.split("/");
	return {
		type: components[0] == "bags" ? "bag" : "recipe",
		name: components[1] || components[0]
	};
};

adaptor.generateETag = function(workspace, tiddler) {
	var revision = tiddler.fields["server.page.revision"];
	var etag = revision == "false" ? null : tiddler.fields["server.etag"];
	if(!etag && workspace.type == "bag") {
		if(typeof revision == "undefined") {
			revision = "0";
		} else if(revision == "false") {
			return null;
		}
		etag = [adaptor.normalizeTitle(workspace.name),
			adaptor.normalizeTitle(tiddler.title), revision].join("/");
		etag = '"' + etag + '"';
	}
	return etag;
};

adaptor.normalizeTitle = function(title) {
	return encodeURIComponent(title);
};

})(jQuery);


/*
 * jQuery JSON Plugin
 * version: 1.3
 * source: http://code.google.com/p/jquery-json/
 * license: MIT (http://www.opensource.org/licenses/mit-license.php)
 */
(function($){function toIntegersAtLease(n)
{return n<10?'0'+n:n;}
Date.prototype.toJSON=function(date)
{return this.getUTCFullYear()+'-'+
toIntegersAtLease(this.getUTCMonth())+'-'+
toIntegersAtLease(this.getUTCDate());};var escapeable=/["\\\x00-\x1f\x7f-\x9f]/g;var meta={'\b':'\\b','\t':'\\t','\n':'\\n','\f':'\\f','\r':'\\r','"':'\\"','\\':'\\\\'};$.quoteString=function(string)
{if(escapeable.test(string))
{return'"'+string.replace(escapeable,function(a)
{var c=meta[a];if(typeof c==='string'){return c;}
c=a.charCodeAt();return'\\u00'+Math.floor(c/16).toString(16)+(c%16).toString(16);})+'"';}
return'"'+string+'"';};$.toJSON=function(o,compact)
{var type=typeof(o);if(type=="undefined")
return"undefined";else if(type=="number"||type=="boolean")
return o+"";else if(o===null)
return"null";if(type=="string")
{return $.quoteString(o);}
if(type=="object"&&typeof o.toJSON=="function")
return o.toJSON(compact);if(type!="function"&&typeof(o.length)=="number")
{var ret=[];for(var i=0;i<o.length;i++){ret.push($.toJSON(o[i],compact));}
if(compact)
return"["+ret.join(",")+"]";else
return"["+ret.join(", ")+"]";}
if(type=="function"){throw new TypeError("Unable to convert object of type 'function' to json.");}
var ret=[];for(var k in o){var name;type=typeof(k);if(type=="number")
name='"'+k+'"';else if(type=="string")
name=$.quoteString(k);else
continue;var val=$.toJSON(o[k],compact);if(typeof(val)!="string"){continue;}
if(compact)
ret.push(name+":"+val);else
ret.push(name+": "+val);}
return"{"+ret.join(", ")+"}";};$.compactJSON=function(o)
{return $.toJSON(o,true);};$.evalJSON=function(src)
{return eval("("+src+")");};$.secureEvalJSON=function(src)
{var filtered=src;filtered=filtered.replace(/\\["\\\/bfnrtu]/g,'@');filtered=filtered.replace(/"[^"\\\n\r]*"|true|false|null|-?\d+(?:\.\d*)?(?:[eE][+\-]?\d+)?/g,']');filtered=filtered.replace(/(?:^|:|,)(?:\s*\[)+/g,'');if(/^[\],:{}\s]*$/.test(filtered))
return eval("("+src+")");else
throw new SyntaxError("Error parsing JSON, source is not valid.");};})(jQuery);
//}}}
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
/*{{{*/
.tiddler .originButton div {
	display: inline-block;
}

.tiddler .spaceSiteIcon .siteIcon {
	_display: inline; /* IE doesn't like inline-block */
}

.tiddler .originButton {
	display: block;
}

.selected .tagging,
.selected .tagged,
.selected .tagging:hover,
.selected .tagged:hover {
	border: none;
	background: none;
}

.tagged {
	float: right;
	position: relative;
	right: -2.4em;
}

.tiddler .tagged ul {
	margin: 0;
}

.tagging {
	float: none;
}

.tagging, .tagged {
	background: none;
	border: none;
}

.tagging li.listTitle {
	margin-left: 0px;
}
.tagging li {
	display: block;
	margin-right: 8px;
	clear: both;
	margin-left: 8px;
}

.tagging .tiddlyLink {
	-webkit-border-radius: 3px;
	-moz-border-radius: 3px;
	-o-border-radius: 3px;
	border-radius: 3px;
	margin: 0;
	padding: 1px 2px;
	line-height: 1.2em;
}

.tagged .button {
	-webkit-border-radius: 15px 0px 0px 15px;
	-moz-border-radius: 15px 0px 0px 15px;
	-o-border-radius: 15px 0px 0px 15px;
	border-radius: 15px 0px 0px 15px;
	background-color: white;
	border-bottom: 2px solid #ccc;
	border-left: 2px solid #ccc;
	border-top: 2px solid #ccc;
	display: block;
	margin: 0 0 0.3em -1.1em;
	padding: 0.4em;
	font-size: 0.9em;
	width: 8em;
	word-wrap: break-word;
	color: [[ColorPalette::Background]];
	background: [[ColorPalette::TertiaryMid]];
}

/* for following */
#popup .siteIcon {
	float: left;
	height: 25px;
}

.content {
	position: relative;
	top: 0;
	left: 0;
	width: 100%; /* IE */
	font-size: 0.9em;
}

.content .info {
	float: right;
	position: relative;
	right: 1em;
	top: 0;
	width: 9em;
	z-index: 2;
}

.editorHeading {
	height: 48px;
}

.heading {
	left: 0;
	margin-bottom: 40px;
	position: relative;
	top: 32px;
}

.followButton a {
	display: block;
	margin-top: -20px;
}

.tiddler .followPlaceHolder {
	display: block;
	position: absolute;
	top: 16px;
	right: 64px;
	_right: 138px; // add width of modifierIcon
}

.tiddler .followButton {
	position: relative;
	height: 24px;
	text-align: left;
	color: #fff;
	background: [[ColorPalette::PrimaryMid]];
	padding: 10px 0px 0px 10px;
	width: 38px;
	margin: -16px -8px 24px 0;
}

/* creates the larger triangle */
.followButton:before {
	content: "\00a0";
	display: block; /* reduce the damage in FF3.0 */
	position: relative;
	bottom: -20px;
	right: 0;
	width: 0;
	height: 0;
	border-width: 0 0 20px 20px;
	border-style: solid;
	border-color: transparent [[ColorPalette::PrimaryMid]];
}

.toolbar svg {
	height: 16px;
	width: 16px;
}

.toolbar svg .glyph {
	fill: #ccc;
}

.toolbar a:hover .glyph {
	fill: black;
}

.toolbar a:active .glyph {
	fill: [[ColorPalette::Background]];
}

.originButton,
.followPlaceHolder,
.tiddler .subtitle {
	cursor: pointer;
}

.editSpaceSiteIcon .originButton {
	cursor: auto;
}

.tiddler .subtitle:hover {
	font-weight: bold;
	background: none;
}

a.originButton:hover {
	color: [[ColorPalette::PrimaryMid]];
}

.originButton img,
.originButton svg {
	margin-left: 0px;
}

.modifierIcon {
	margin-right: 0px;
	position: absolute;
	width: 74px;
	top: 0px;
	right: 0px;
	_right: 74px; /* in IE6 positioning works incorrectly so use -width instead */
	text-align: right;
}

.modifierIcon .siteIcon div {
	height: 52px; /* include border */
}

.modifierIcon img,
.modifierIcon svg {
	margin-right: 8px;
}

.tiddler .viewer {
	padding-bottom: 16px;
	margin: 0 0 0 56px;
	line-height: 1.4em;
}

.viewer pre {
	margin-left: 0;
}

.spaceIcon img {
	height: 40px;
}

.siteIcon .label {
	color: [[ColorPalette::TertiaryDark]];
}

.tiddler .spaceSiteIcon {
	float: left;
	margin-right: 0;
	margin-top: 0;
	position: relative;
	display: block;
}

.tiddler .titleBar {
	display: block;
	margin-right: 136px;
	margin-left: 56px;
}

.followButton a {
	color: [[ColorPalette::Background]];
}

.tiddler {
	position: relative;
	padding: 0;
	margin-bottom: 3em;
	border-top: 3px solid [[ColorPalette::PrimaryMid]];
	background: #fff;
}

.tiddler .editor {
	padding-left: 8px;
	padding-right: 8px;
}

.tiddler .heading .title {
	position: relative;
	display: block;
	word-wrap: break-word;
	font-size: 24px;
	line-height: 24px;
}
.tiddler .heading .editor.title {
	font-size: 1.7em;
	line-height: normal;
}

.tiddler .title a {
	color: [[ColorPalette::Foreground]];
	text-decoration: none;
}
.tiddler .title a:hover {
	background: none;
	color: [[ColorPalette::Foreground]];
	text-decoration: none;
}

.tiddler .headingClear {
	clear: both;
}

.tiddler .subtitle {
	font-style: italic;
	font-size: 0.9em;
	color: #a6a59e;
	margin-top: 0;
}

.toolbar {
	position: absolute;
	padding: 0;
	top: 8px;
	right: -8px;
}

.toolbar .moreCommand.highlight {
	background: none;
}

.tiddler .toolbar .button {
	border: none;
	display: inline;
	padding: 0px;
	margin-right: 16px;
}

.tiddler .toolbar a:hover {
	background: none;
}

.tiddler .tags {
	float: right;
}

.tiddler .tags .listTitle {
	display: none;
}

.tiddler .tags li {
	font-size: 0.9em;
	list-style: none;
	margin-bottom: 8px;
	overflow: hidden;
	margin-right: 8px;
	text-align: right;
	border-bottom: solid 2px [[ColorPalette::PrimaryPale]];
}

.tiddler .tags li .button {
	padding: 0px;
}

.tiddler .tagged .listTitle {
	display: none;
}

.revButton {
	float: right;
}

/*! EditTemplate specific*/
.tiddler .privacySettings {
	text-align: center;
}
.tiddler .privacySettings .originButton {
	display: inline;
}

.editSpaceSiteIcon, .privacyEdit {
	float: left;
}

.editSpaceSiteIcon svg,
.editSpaceSiteIcon img,
.editSpaceSiteIcon .roundelLabel {
	float: left;
}

.tagTitle {
	position: absolute;
	text-align: center;
	width: 48px;
	top: 0px;
	left: -56px;
}

.editSpaceSiteIcon .originButton img,
.editSpaceSiteIcon .originButton svg {
	height: 16px;
	margin-left: 24px;
	margin-right: 32px;
	width: 16px;
}

.tagAnnotation {
	margin-top: 8px;
	padding-bottom: 8px;
}
.annotationsBox {
	margin-top: 8px;
}

.editorFooter {
	position: relative;
	padding: 0;
	margin-top: 16px;
	margin-left: 64px;
}

.tiddler .editorFooter .editor {
	padding-left: 0px;
}

.heading .editor input {
	width: 100%;
	font-size: 1.5em;
}

.spaceSiteIcon .externalImage .image a:hover,
.modifierIcon .externalImage .image a:hover {
	background: none;
}

div.toolbar {
	visibility:hidden;
	right:-16px;
}

.selected div.toolbar {
	visibility: visible;
}

.followButton a:hover {
	background: [[ColorPalette::PrimaryMid]];
	text-decoration: underline;
}

@media all and (max-device-width: 480px) {
	div.toolbar {
		visibility:visible;
	}
}
@media only screen and (device-width: 768px) {
	div.toolbar {
		visibility:visible;
	}
}
@media all and (max-width: 960px) {
	.tiddler .titleBar {
		margin-left: 36px;
		margin-right: 80px;
	}

	.tiddler .heading {
		margin-bottom: 48px;
	}

	.tiddler .heading .title {
		font-size: 32px;
		line-height: 32px;
	}

	.tiddler .modifierIcon img,
	.tiddler .modifierIcon svg,
	.tiddler .spaceSiteIcon .originButton img,
	.originButton svg {
		width: 32px;
		height: 32px;
		margin-left: 0px;
		margin-right: 0px;
	}

	.tiddler .followPlaceHolder {
		right: 48px;
	}

	.tiddler .followButton {
		width: 24px;
	}

	.tiddler .viewer {
		margin: 0px 0px 0px 36px;
		padding-top: 0;
	}

	br {
		line-height: 0.5em;
	}
}
/*}}}*/
/***
|Name|SnapshotPlugin|
|Source|http://www.TiddlyTools.com/#SnapshotPlugin|
|Documentation|http://www.TiddlyTools.com/#SnapshotPluginInfo|
|Version|1.3.0|
|Author|Eric Shulman|
|License|http://www.TiddlyTools.com/#LegalStatements|
|~CoreVersion|2.1|
|Type|plugin|
|Description|save or print HTML+CSS image of rendered document content|
This plugin provides a macro as well as tiddler toolbar commands to create a file or browser window containing the //rendered// CSS-and-HTML that is currently being displayed for selected elements of the current document.
!!!!!Documentation
>see [[SnapshotPluginInfo]]
!!!!!Configuration
<<<
<<option chkSnapshotHTMLOnly>> output HTML only (omit CSS)
<<<
!!!!!Revisions
<<<
2009.10.12 1.3.0 added multi-file story snapshot
|please see [[SnapshotPluginInfo]] for additional revision details|
2008.04.21 1.0.0 initial release - derived from [[NewDocumentPlugin]] with many improvements...
<<<
!!!!!Code
***/
//{{{
version.extensions.SnapshotPlugin= {major: 1, minor: 3, revision: 0, date: new Date(2009,10,12)};

if (config.options.chkSnapshotHTMLOnly===undefined)
	config.options.chkSnapshotHTMLOnly=false;

config.macros.snapshot = {
	snapLabel: "save a snapshot",
	printLabel: "print a snapshot",
	snapPrompt: "save an HTML image",
	printPrompt: "print an HTML image",
	hereID: "here",
	viewerID: "viewer",
	storyID: "story",
	allID: "all",
	askID: "ask",
	askTiddlerID: "askTiddler",
	askDOMID: "askDOM",
	askMsg: "select an element...",
	hereItem: "tiddler: '%0'",
	viewerItem: "tiddler: '%0' (content only)",
	storyItem: "story column (one file)",
	storyFilesItem: "story column (multiple files)",
	allItem: "entire document",
	tiddlerItem: "select a tiddler...",
	IDItem: "select a DOM element by ID...",
	HTMLItem: "[%0] output HTML only (omit CSS)",
	fileMsg: "select or enter a target path/filename",
	defaultFilename: "snapshot.html",
	okmsg: "snapshot written to %0",
	failmsg: "An error occurred while creating %0",
	handler: function(place,macroName,params,wikifier,paramString,tiddler) {
		var printing=params[0]&&params[0]=="print"; if (printing) params.shift();
		params = paramString.parseParams("anon",null,true,false,false);
		var id=getParam(params,"id","here");
		var label=getParam(params,"label",printing?this.printLabel:this.snapLabel);
		var prompt=getParam(params,"prompt",printing?this.printPrompt:this.snapPrompt);
		var btn=createTiddlyButton(place,label,prompt, function(ev){
			this.setAttribute("snapID",this.getAttribute("startID"));
			config.macros.snapshot.go(this,ev)
		});
		btn.setAttribute("startID",id);
		btn.setAttribute("snapID",id);
		btn.setAttribute("printing",printing?"true":"false");
		btn.setAttribute("HTMLOnly",config.options.chkSnapshotHTMLOnly?"true":"false");
	},
	go: function(here,ev) {
		var cms=config.macros.snapshot; // abbreviation
		var id=here.getAttribute("snapID");
		var printing=here.getAttribute("printing")=="true";
		var HTMLOnly=here.getAttribute("HTMLOnly")=="true";

		if (id==cms.askID||id==cms.askTiddlerID||id==cms.askDOMID) {
			cms.askForID(here,ev);
		} else if (id==cms.storyID) {
			story.forEachTiddler(function(t,e) {
				var out=cms.getsnap(e,e.id,printing,HTMLOnly);
				if (printing) cms.printsnap(out);
				else cms.savesnap(out,e.getAttribute('tiddler')+'.html');
			});
		} else {
			if (id==cms.allID) id="contentWrapper";
			var snapElem=document.getElementById(id);
			if (id==cms.hereID || id==cms.viewerID)
				var snapElem=story.findContainingTiddler(here);
			if (snapElem && hasClass(snapElem,"tiddler") && (id==cms.viewerID || HTMLOnly)) {
				// find viewer class element within tiddler element
				var nodes=snapElem.getElementsByTagName("*");
				for (var i=0; i<nodes.length; i++)
					if (hasClass(nodes[i],"viewer")) { snapElem=nodes[i]; break; }
			}
			if (!snapElem) // not in a tiddler or no viewer element or unknown ID
				{ e.cancelBubble=true; if(e.stopPropagation)e.stopPropagation(); return(false); }
			// write or print snapshot
			var out=cms.getsnap(snapElem,id,printing,HTMLOnly);
			if (printing) cms.printsnap(out); else cms.savesnap(out);
		}
		return false;
	},
	askForID: function(here,ev) {
		var ev = ev ? ev : window.event; 
		var cms=config.macros.snapshot; // abbreviation
		var id=here.getAttribute("snapID");
		var indent='\xa0\xa0\xa0\xa0';
		var p=Popup.create(here); if (!p) return false; p.className+=' sticky smallform';
		var s=createTiddlyElement(p,'select'); s.button=here;
		if (id==cms.askID) {
			s.options[s.length]=new Option(cms.askMsg,cms.askID);
			var tid=story.findContainingTiddler(here);
			if(tid) { 
				var title=tid.getAttribute("tiddler");
				if (here.getAttribute("HTMLOnly")!="true")
					s.options[s.length]=new Option(indent+cms.hereItem.format([title]),cms.hereID);
				s.options[s.length]=new Option(indent+cms.viewerItem.format([title]),cms.viewerID);
			}
			s.options[s.length]=new Option(indent+cms.tiddlerItem,cms.askTiddlerID);
			s.options[s.length]=new Option(indent+cms.IDItem,cms.askDOMID);
			s.options[s.length]=new Option(indent+cms.storyItem,"tiddlerDisplay");
			s.options[s.length]=new Option(indent+cms.storyFilesItem,cms.storyID);
			s.options[s.length]=new Option(indent+cms.allItem,"contentWrapper");
		}
		if (id==cms.askDOMID) {
			s.options[s.length]=new Option(cms.IDItem,cms.askDOMID);
			var elems=document.getElementsByTagName("*");
			var ids=[];
			for (var i=0;i<elems.length;i++)
				if (elems[i].id.length && elems[i].className!="animationContainer")
					ids.push(elems[i].id);
			ids.sort();
			for (var i=0;i<ids.length;i++) s.options[s.length]=new Option(indent+ids[i],ids[i]);
		}
		if (id==cms.askTiddlerID) {
			s.options[s.length]=new Option(cms.tiddlerItem,cms.askTiddlerID);
			var elems=document.getElementsByTagName("div");
			var ids=[];
			for (var i=0;i<elems.length;i++) { var id=elems[i].id;
				if (id.length && id.substr(0,story.idPrefix.length)==story.idPrefix && id!="tiddlerDisplay")
					ids.push(id);
			}
			ids.sort();
			for (var i=0;i<ids.length;i++) s.options[s.length]=new Option(indent+ids[i].substr(story.idPrefix.length),ids[i]);
		}
		s.options[s.length]=new Option(cms.HTMLItem.format([here.getAttribute("HTMLOnly")=="true"?"\u221a":"_"]),cms.HTMLItem);
		s.onchange=function(ev){
			var ev = ev ? ev : window.event; 
			var cms=config.macros.snapshot; // abbreviation
			var here=this.button;
			if (this.value==cms.HTMLItem) {
				config.options.chkSnapshotHTMLOnly=!config.options.chkSnapshotHTMLOnly;
				here.setAttribute("HTMLOnly",config.options.chkSnapshotHTMLOnly?"true":"false");
				config.macros.option.propagateOption("chkSnapshotHTMLOnly","checked",
					config.options.chkSnapshotHTMLOnly,"input");
			} else
				here.setAttribute("snapID",this.value);
			config.macros.snapshot.go(here,ev);
			return false;
		};
		Popup.show();
		ev.cancelBubble=true;
		if(ev.stopPropagation)ev.stopPropagation();
		return false;
	},
	getpath: function() {
		// get current path
		var path=getLocalPath(window.location.href);
		var slashpos=path.lastIndexOf("/");
		if (slashpos==-1) slashpos=path.lastIndexOf("\\"); 
		if (slashpos!=-1) path=path.substr(0,slashpos+1); // trim filename
		return path;
	},
	getsnap: function(snapElem,id,printing,HTMLOnly) {
		var cms=config.macros.snapshot; // abbreviation
		var out='<head><meta http-equiv="Content-Type" content="text/html;charset=utf-8" />';
		if (printing)
			out+='<base href="file:///'+cms.getpath().replace(/\\/g,'/')+'"></base>\n';
		if (!HTMLOnly) {
			var styles=document.getElementsByTagName('style');
			var fmt='<style>\n/* stylesheet=%0 */\n%1\n\n</style>\n';
			for(var i=0; i < styles.length; i++)
				out+=fmt.format([styles[i].getAttribute('id'),styles[i].innerHTML]);
		}
		out+='</head>\n';

		var elems=snapElem.getElementsByTagName('input');
		for (var i=0; i<elems.length; i++) { var e=elems[i];
			if (e.type=='text')		e.defaultValue=e.value;
			if (e.type=='checkbox')	 	e.defaultChecked=e.checked;
			if (e.type=='radiobutton')	e.defaultChecked=e.checked;
		}
		var elems=snapElem.getElementsByTagName('textarea');
		for (var i=0; i<elems.length; i++)	elems[i].defaultValue=elems[i].value;

		var fmt='<body>\n\n<div class="%0">%1</div>\n\n</body>\n';
		out+=fmt.format([(id==cms.viewerID?'tiddler viewer':''),snapElem.innerHTML]);

		return '<html>\n'+out+'</html>';
	},
	printsnap: function(out) {
		var win=window.open("","_blank","");
		win.document.open();
		win.document.writeln(out);
		win.document.close();
		win.focus(); // bring to front
		win.print(); // trigger print dialog
	},
	savesnap: function(out,target) {
		var cms=config.macros.snapshot; // abbreviation
		// make sure we are local
		if (window.location.protocol!="file:")
			{ alert(config.messages.notFileUrlError); return; }
		var target=target||cms.askForFilename(cms.fileMsg,cms.getpath(),cms.defaultFilename);
		if (!target) return; // cancelled by user
		// if specified file does not include a path, assemble fully qualified path and filename
		var slashpos=target.lastIndexOf("/"); if (slashpos==-1) slashpos=target.lastIndexOf("\\");
		if (slashpos==-1) {
			var h=document.location.href;
			var cwd=getLocalPath(decodeURIComponent(h.substr(0,h.lastIndexOf('/')+1)));
			target=cwd+target;
		}
		var link="file:///"+target.replace(/\\/g,'/'); // link for message text
		var ok=saveFile(target,convertUnicodeToUTF8(out));
		var msg=ok?cms.okmsg.format([target]):cms.failmsg.format([target]);
		displayMessage(msg,link);
	},
	askForFilename: function(msg,path,file) {
		if(window.Components) { // moz
			try {
				netscape.security.PrivilegeManager.enablePrivilege('UniversalXPConnect');
				var nsIFilePicker = window.Components.interfaces.nsIFilePicker;
				var picker = Components.classes['@mozilla.org/filepicker;1'].createInstance(nsIFilePicker);
				picker.init(window, msg, nsIFilePicker.modeSave);
				var thispath = Components.classes['@mozilla.org/file/local;1'].createInstance(Components.interfaces.nsILocalFile);
				thispath.initWithPath(path);
				picker.displayDirectory=thispath;
				picker.defaultExtension='html';
				picker.defaultString=file;
				picker.appendFilters(nsIFilePicker.filterAll|nsIFilePicker.filterText|nsIFilePicker.filterHTML);
				if (picker.show()!=nsIFilePicker.returnCancel) var result=picker.file.persistentDescriptor;
			}
			catch(e) { alert('error during local file access: '+e.toString()) }
		}
		else { // IE
			try { // XP/Vista only
				var s = new ActiveXObject('UserAccounts.CommonDialog');
				s.Filter='All files|*.*|Text files|*.txt|HTML files|*.htm;*.html|';
				s.FilterIndex=3; // default to HTML files;
				s.InitialDir=path;
				s.FileName=file;
				if (s.showOpen()) var result=s.FileName;
			}
			catch(e) { var result=prompt(msg,path+file); } // fallback for non-XP IE
		}
		return result;
	}
};
//}}}

// // TOOLBAR DEFINITIONS
//{{{
config.commands.snapshotSave = {
	text: "snap",
	tooltip: config.macros.snapshot.snapPrompt,
	handler: function(ev,src,title) {
		src.setAttribute("snapID","ask");
		src.setAttribute("printing","false");
		src.setAttribute("HTMLOnly",config.options.chkSnapshotHTMLOnly?"true":"false");
		config.macros.snapshot.go(src,ev);
		return false;
	}
};
config.commands.snapshotPrint = {
	text: "print",
	tooltip: config.macros.snapshot.printPrompt,
	handler: function(ev,src,title) {
		src.setAttribute("snapID","ask");
		src.setAttribute("printing","true");
		src.setAttribute("HTMLOnly",config.options.chkSnapshotHTMLOnly?"true":"false");
		config.macros.snapshot.go(src,ev);
		return false;
	}
};
//}}}

// // COPIED FROM [[StickyPopupPlugin]] TO ELIMINATE PLUGIN DEPENDENCY
//{{{
if (config.options.chkStickyPopups==undefined) config.options.chkStickyPopups=false;
Popup.stickyPopup_onDocumentClick = function(ev)
{
	// if click is in a sticky popup, ignore it so popup will remain visible
	var e = ev ? ev : window.event; var target = resolveTarget(e);
	var p=target; while (p) {
		if (hasClass(p,"popup") && (hasClass(p,"sticky")||config.options.chkStickyPopups)) break;
		else p=p.parentNode;
	}
	if (!p) // not in sticky popup (or sticky popups disabled)... use normal click handling
		Popup.onDocumentClick(ev);
	return true;
};
try{removeEvent(document,"click",Popup.onDocumentClick);}catch(e){};
try{addEvent(document,"click",Popup.stickyPopup_onDocumentClick);}catch(e){};
//}}}
/%

Hello,

If you choose to change this GettingStarted tiddler, you may wish to add the following to your new content if you expect you space to be included:

<<<
----
Hello,
''This ~GettingStarted tiddler has been customized.''
If you want to see the original system tiddler just click the following link: GettingStarted@system-info at system-info.
<<<
%/

Welcome to your brand new [[TiddlySpace|http://docs.tiddlyspace.com/TiddlySpace]].

You're almost ready to go, there are just a couple of things left to do.

!Customise your space
Go to [[SpaceSettings]] to finish customising  your space. When you're done, come back here (just scroll up). Don't worry though, this will still be open when you've finished.

!Further Customisation

For advanced options, the [[ServerSettings]] tiddler is used to enable the following features:

#index: The value is the name of a tiddler that will be presented when loading the space.  For example, when set to {{{Hello}}} for the space hello.tiddlyspace.com, navigating to that URL will present the Hello tiddler. If there is no {{{Hello}}} you will get an error.
#editor: The name of an [[editor application|http://docs.tiddlyspace.com/Example%20Tiddler%20Editors]] to edit tiddlers with.  Applications come from [[included spaces|http://docs.tiddlyspace.com/How%20do%20I%20include%2Fexclude%20spaces%3F]]

//If you do not need or understand these features there is no need to create a ServerSettings tiddler.//

To edit these options: 

* click [[here|ServerSettings]] to open the [[ServerSettings]] tiddler
* click on the edit button (the pencil icon)
* add the options you wish to set 
* click on the save button (the tick icon).

An example [[ServerSettings]] tiddler:
{{{
index: HelloThere
editor: /edit#{tiddler}
}}}

The additional text after /edit allows a tiddler to be opened in edit mode e.g:
{{{http://hello.tiddlyspace.com/edit#MyTiddler}}}

!!See Also

* [[ServerSettings shadow tiddler|http://docs.tiddlyspace.com/ServerSettings%20shadow%20tiddler]]
* [[Choosing a non-TiddlyWiki Default Application for your Space|http://docs.tiddlyspace.com/Choosing%20a%20non-TiddlyWiki%20Default%20Application%20for%20your%20Space]]

!Finished customising?
You can [[Start writing]] some [[tiddlers|http://docs.tiddlyspace.com/Tiddler]].
If you're not done tweaking yet though, you can always [[Customise this space|SpaceSettings]] a bit more.

You can also [[access and read other tiddlers in various ways|http://docs.tiddlyspace.com/Viewing%20Tiddlers]].

!Administration
If you'd like to change your password or create another space, visit "Your Account" from the [[Universal Backstage|http://docs.tiddlyspace.com/UniversalBackstage]] (the blue dot in the upper right of the page). If you'd like to add a member or [[include a space|http://docs.tiddlyspace.com/How%20do%20I%20include%2Fexclude%20spaces%3F]] visit "This Space" from the [[Universal Backstage|http://docs.tiddlyspace.com/UniversalBackstage]].

You can have as many spaces as you like and each space can have as many members as you or your group need.

!Stuck?
If you're stuck, and would like some help, please visit the [[help|http://help.tiddlyspace.com]] space, which can point you in the right direction.
/***
|Name|SnapshotPluginInfo|
|Source|http://www.TiddlyTools.com/#SnapshotPlugin|
|Documentation|http://www.TiddlyTools.com/#SnapshotPluginInfo|
|Version|1.3.0|
|Author|Eric Shulman|
|License|http://www.TiddlyTools.com/#LegalStatements|
|~CoreVersion|2.1|
|Type|documentation|
|Description|Documentation for SnapshotPlugin|
This plugin provides a macro as well as tiddler toolbar commands that creates a file or opens a new browser window containing the //rendered// HTML and CSS style definitions that are being displayed for selected elements of the current document.
!!!!!Usage:
<<<
As a macro embedded in tiddler content:
{{{
<<snapshot print label:text prompt:text id:elementID|here|viewer|story|all|ask>
}}}
where:
*''print'' //(optional)//<br>when present, causes the snapshot output to be directed to a new browser tab/window instead of saving it to a file.  In addition, the print dialog for that tab/window is automatically invoked.
*''label'' //(optional)//<br>is the text to be displayed for the command link generated by the macro
*''prompt'' //(optional)//<br>is the 'tool tip' message displayed when you mouseover the command link
*''id:...'' //(optional)//<br>specifies the document element to be captured, and can be one of:
**''elementID''<br>is a specific DOM element ID, such as "displayArea", "mainMenu", "contentWrapper", etc.
**''here''<br>the containing tiddler in which the macro (or toolbar command) occurs, including the tiddler title and subtitle (date/time/author) information.
**''viewer''<br>same as ''here'', but omits the tiddler title, subtitle and toolbar elements (i.e., it includes //only// the content of the tiddler)
**''story''<br>selects all currently displayed tiddlers (i.e., the 'story column')
**''all''<br>selects the entire document contents, including page header, main menu and sidebar displays
**''ask''<br>when the snapshot command link is clicked, a droplist is displayed so you can choose from several pre-defined elements: "current tiddler", "story column", or "entire document", or "DOM element ID..."  When DOM element ID is chosen, the droplist is refreshed to show the individual ID's for all currently rendered DOM elements (at least, the ones that have ID's).  For any given DOM element ID, only the portions of the document that are contained //within// the specified DOM element will be transcribed to the resulting snapshot or print output.  
//''NOTE: when no parameters are specified, the macro creates a snapshot file using the containing tiddler as the default element.'' (e.g., equivalent to {{{<<snapshot id:here>>}}}//

The snapshot/print functions can also be embedded as tiddler toolbar commands in [[ViewTemplate]]:
{{{
<span class='toolbar' macro='toolbar snapshotSave'></span>
<span class='toolbar' macro='toolbar snapshotPrint'></span>
}}}
* when invoked via toolbar commands, the "id:ask" option is automatically applied, and a droplist of elements to choose from is displayed.

Please note that, although the snapshot/print that is created using the HTML+CSS of the displayed content, ''there is NO javascript code'' written into the snapshot.  As a result, the snapshot only ''reproduces the //appearance// of the displayed content, allowing you to //view// or //print// the result'', but does not permit you to interact with it in other ways.

For example, even simple processing (such as mouseover highlighting) will not function from the snapshot.  You can't click a TiddlyLink to open other tiddlers, because A) there is no code that handles the click and B) there is no underlying 'storeArea' (and core code) to retrieve and render anything!  You also can't use ANY command links, since these also require javascript code (and the core) to operate. 
<<<
!!!!!Examples:
<<<
{{{<<snapshot>>}}}: <<snapshot>>
{{{<<snapshot id:mainMenu>>}}}: <<snapshot id:mainMenu>>
{{{<<snapshot print id:story>>}}}: <<snapshot print id:story>>
{{{<<snapshot print id:ask>>}}}: <<snapshot print id:ask>>
{{{<<snapshot print noCSS id:viewer>>}}}: <<snapshot print noCSS id:viewer>>
<<<
!!!!!Configuration
<<<
<<option chkSnapshotHTMLOnly>> output HTML only (omit CSS)
<<<
!!!!!Revisions
<<<
2009.10.12 1.3.0 added multi-file story snapshot
2009.09.25 1.2.1 in getSnap(), added META tag to set UTF-8 encoding for I18N support
2009.06.04 1.2.0 added handling in getSnap() so current form input values are shown in snapshots
2008.05.16 1.1.1 added try..catch around addEvent/removeEvent calls to avoid error in Opera
2008.04.28 1.1.0 removed 'viewerHTML' from 'ask' droplist and replaced with toggle for "output HTML only".  Removed 'noCSS' parameter and replaced with config.options.chkSnapshotHTMLOnly global option.  Added "select a tiddler..." to 'ask' droplist
2008.04.24 1.0.1 in saveSnap(), convert output from Unicode to UTF before passing to saveFile().  Fixes "unknown name" error in IE's file.Write() function.
2008.04.21 1.0.0 initial release - derived from [[NewDocumentPlugin]] with many improvements, including: "ask for ID" using droplist of available DOM elements, use "<base href=...>" for correctly resolving image references, wrap 'viewer only' output in class="tiddler viewer" for proper application of inherited CSS styles, snapshotSave and snapshotPrint tiddler toolbar command definitions, and more...

__Excerpted revisions from [[NewDocumentPlugin]] (obsolete)__
2008.04.20 1.8.0 added support for 'noCSS' and 'viewer' params for alternative snapshot output
2007.03.30 1.7.0 added support for "print" param as alternative for "snap".  When "print" is used, the filename is ignored and ouput is directed to another browser tab/window, where the print dialog is then automatically triggered.
2007.03.30 1.6.1 added support for "here" keyword for current tiddler elementID and "prompt:text" param for specifying tooltip text
2006.10.18 1.5.0 new optional param for 'snap'... specify alternative DOM element ID (default is still "contentWrapper").  Based on a suggestion from Xavier Verges.
2006.03.09 1.2.0 added special "snap" filter parameter to generate and write "snapshot" files containing static HTML+CSS for currently rendered document.
2006.02.03 1.0.0 Created.
<<<
/***
|''Name''|TiddlySpacePublishingCommands|
|''Version''|0.8.5|
|''Status''|@@beta@@|
|''Description''|toolbar commands for drafting and publishing|
|''Author''|Jon Robson|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/TiddlySpacePublishingCommands.js|
|''CoreVersion''|2.6.1|
|''Requires''|TiddlySpaceConfig TiddlySpaceFilters|
!Usage
Provides changeToPrivate, changeToPublic and saveDraft commands
Provides TiddlySpacePublisher macro.
{{{<<TiddlySpacePublisher type:private>>}}} make lots of private tiddlers public.
{{{<<TiddlySpacePublisher type:public>>}}} make lots of public tiddlers public.
!TODO
* add public argument?
!Code
***/
//{{{
(function($) {

var tiddlyspace = config.extensions.tiddlyspace;
var originMacro = config.macros.tiddlerOrigin;

tiddlyspace.getTiddlerStatusType = function(tiddler) {
	var isShadow = store.isShadowTiddler(tiddler.title);
	var exists = store.tiddlerExists(tiddler.title);
	if(isShadow && !exists) {
		return "shadow";
	} else if(!exists) {
		return "missing";
	} else {
		var types = ["private", "public"];
		var type = "external";
		for(var i = 0; i < types.length; i++) {
			var t = types[i];
			type = config.filterHelpers.is[t](tiddler) ? t : type;
		}
		if(config.filterHelpers.is.unsynced(tiddler)) {
			type = type == "private" ? "unsyncedPrivate" : "unsyncedPublic";
		}
		return type;
	}
};

var cmd = config.commands.publishTiddler = {
	text: "make public",
	tooltip: "Change this private tiddler into a public tiddler",
	errorMsg: "Error publishing %0: %1",

	isEnabled: function(tiddler) {
		return !readOnly && config.filterHelpers.is["private"](tiddler);
	},
	handler: function(ev, src, title) {
		var tiddler = store.getTiddler(title);
		if(tiddler) {
			var newBag = cmd.toggleBag(tiddler.fields["server.bag"]);
			this.moveTiddler(tiddler, {
				title: tiddler.fields["publish.name"] || tiddler.title,
				fields: { "server.bag": newBag }
			});
		}
	},
	toggleBag: function(bag, to) {
		var newBag;
		if(typeof bag != typeof "") {
			var tiddler = bag;
			bag = tiddler.fields["server.bag"];
		}
		if(bag.indexOf("_private") > -1) { // should make use of endsWith
			to = to ? to : "public";
			newBag = bag.replace("_private", "_" + to);
		} else {
			to = to ? to : "private";
			newBag = bag.replace("_public", "_" + to);
		}
		return newBag;
	},
	copyTiddler: function(title, newTitle, newBag, callback) {
		var original = store.getTiddler(title);
		newTitle = newTitle ? newTitle : title;
		var adaptor = original.getAdaptor();
		var publish = function(original, callback) {
			var tiddler = $.extend(new Tiddler(newTitle), original);
			tiddler.fields = $.extend({}, original.fields, {
				"server.bag": newBag,
				"server.workspace": "bags/%0".format(newBag),
				"server.page.revision": "false"
			});
			delete tiddler.fields["server.title"];
			tiddler.title = newTitle;
			adaptor.putTiddler(tiddler, null, null, callback);
		};
		publish(original, callback);
	},
	moveTiddler: function(tiddler, newTiddler, callback) {
			var info = {
			copyContext: {},
			deleteContext: {}
		};
		var _dirty = store.isDirty();
		var adaptor = tiddler.getAdaptor();
		var newTitle = newTiddler.title;
		var oldTitle = tiddler.title;
		delete tiddler.fields["server.workspace"];
		var oldBag = tiddler.fields["server.bag"];
		var newBag = newTiddler.fields["server.bag"];
		var newWorkspace = "bags/%0".format(newBag);
		cmd.copyTiddler(oldTitle, newTitle, newBag, function(ctx) {
				info.copyContext = ctx;
				var context = {
					tiddler: tiddler,
					workspace: newWorkspace
				};
				store.addTiddler(ctx.tiddler);
				tiddler.title = oldTitle; // for cases where a rename occurs
				if(ctx.status) { // only do if a success
					if(oldBag != newBag) {
						adaptor.deleteTiddler(tiddler, context, {}, function(ctx) {
							info.deleteContext = ctx;
							var el;
							if(tiddler) {
								tiddler.fields["server.workspace"] = newWorkspace;
								tiddler.fields["server.bag"] = newBag;
							}
							el = el ? el : story.refreshTiddler(oldTitle, null, true);
							if(oldTitle != newTitle) {
								store.deleteTiddler(oldTitle);
								store.notify(oldTitle, true);
							}
							if(el) {
								story.displayTiddler(el, newTitle);
							}
							if(oldTitle != newTitle) {
								story.closeTiddler(oldTitle);
							}
							if(callback) {
								callback(info);
							}
							store.setDirty(_dirty);
						});
					} else {
						if(callback) {
							callback(info);
						}
					}
					refreshDisplay();
				}
		});
	}
};

var changeToPrivate = config.commands.changeToPrivate = {
	text: "make private",
	tooltip: "turn this public tiddler into a private tiddler",
	isEnabled: function(tiddler) {
		return !readOnly && config.filterHelpers.is["public"](tiddler);
	},
	handler: function(event, src, title) {
		var tiddler = store.getTiddler(title);
		var newBag = cmd.toggleBag(tiddler, "private");
		var newTiddler = { title: title, fields: { "server.bag": newBag }};
		cmd.moveTiddler(tiddler, newTiddler);
	}
};
config.commands.changeToPublic = cmd;

/* Save as draft command */
var saveDraftCmd = config.commands.saveDraft = {
	text: "save draft",
	tooltip: "Save as a private draft",
	isEnabled: function(tiddler) {
		return changeToPrivate.isEnabled(tiddler);
	},
	getDraftTitle: function(title) {
		var draftTitle;
		var draftNum = "";
		while(!draftTitle) {
			var suggestedTitle = "%0 [draft%1]".format(title, draftNum);
			if(store.getTiddler(suggestedTitle)) {
				draftNum = !draftNum ? 2 : draftNum + 1;
			} else {
				draftTitle = suggestedTitle;
			}
		}
		return draftTitle;
	},
	createDraftTiddler: function(title, gatheredFields) {
		var tiddler = store.getTiddler(title);
		var draftTitle = saveDraftCmd.getDraftTitle(title);
		var draftTiddler = new Tiddler(draftTitle);
		if(tiddler) {
			$.extend(true, draftTiddler, tiddler);
		} else {
			$.extend(draftTiddler.fields, config.defaultCustomFields);
		}
		for(var fieldName in gatheredFields) {
			if(TiddlyWiki.isStandardField(fieldName)) {
				draftTiddler[fieldName] = gatheredFields[fieldName];
			} else {
				draftTiddler.fields[fieldName] = gatheredFields[fieldName];
			}
		}
		var privateBag = tiddlyspace.getCurrentBag("private");
		var privateWorkspace = tiddlyspace.getCurrentWorkspace("private");
		draftTiddler.title = draftTitle;
		draftTiddler.fields["publish.name"] = title;
		draftTiddler.fields["server.workspace"] = privateWorkspace;
		draftTiddler.fields["server.bag"] = privateBag;
		draftTiddler.fields["server.title"] = draftTitle;
		draftTiddler.fields["server.page.revision"] = "false";
		delete draftTiddler.fields["server.etag"];
		return draftTiddler;
	},
	handler: function(ev, src, title) {
		var tiddler = store.getTiddler(title); // original tiddler
		var tidEl = story.getTiddler(title);
		var uiFields = {};
		story.gatherSaveFields(tidEl, uiFields);
		var tid = saveDraftCmd.createDraftTiddler(title, uiFields);
		tid = store.saveTiddler(tid.title, tid.title, tid.text, tid.modifier,
			new Date(), tid.tags, tid.fields);
		autoSaveChanges(null, [tid]);
		story.closeTiddler(title);
		story.displayTiddler(src, title);
		story.displayTiddler(src, tid.title);
	}
};

var macro = config.macros.TiddlySpacePublisher = {
	locale: {
		title: "Batch Publisher",
		changeStatusLabel: "Make %0",
		noTiddlersText: "No tiddlers to publish",
		changeStatusPrompt: "Make all the selected tiddlers %0.",
		description: "Change tiddlers from %0 to %1 in this space"
	},

	listViewTemplate: {
		columns: [
			{ name: "Selected", field: "Selected", rowName: "title", type: "Selector" },
			{ name: "Tiddler", field: "tiddler", title: "Tiddler", type: "Tiddler" },
			{ name: "Status", field: "status", title: "Status", type: "WikiText" }
		],
		rowClasses: []
	},

	changeStatus: function(tiddlers, status, callback) { // this is what is called when you click the publish button
		var publicBag;
		for(var i = 0; i < tiddlers.length; i++) {
			var tiddler = tiddlers[i];
			var newTiddler = {
				title: tiddler.title,
				fields: { "server.bag": cmd.toggleBag(tiddler, status) }
			};
			cmd.moveTiddler(tiddler, newTiddler, callback);
		}
	},
	getMode: function(paramString) {
		var params = paramString.parseParams("anon")[0];
		var status = params.type ?
			(["public", "private"].contains(params.type[0]) ? params.type[0] : "private") :
			"private";
		var newStatus = status == "public" ? "private" : "public";
		return [status, newStatus];
	},
	handler: function(place, macroName, params, wikifier, paramString, tiddler) {
		var wizard = new Wizard();
		var locale = macro.locale;
		var status = macro.getMode(paramString);
		wizard.createWizard(place, locale.title);
		wizard.addStep(macro.locale.description.format(status[0], status[1]),
			'<input type="hidden" name="markList" />');
		var markList = wizard.getElement("markList");
		var listWrapper = $("<div />").addClass("batchPublisher").
			attr("refresh", "macro").attr("macroName", macroName).
			attr("params", paramString)[0];
		markList.parentNode.insertBefore(listWrapper, markList);
		$.data(listWrapper, "wizard", wizard);
		macro.refresh(listWrapper);
	},
	getCheckedTiddlers: function(listWrapper, titlesOnly) {
		var tiddlers = [];
		$(".chkOptionInput[rowName]:checked", listWrapper).each(function(i, el) {
			var title = $(el).attr("rowName");
			if(titlesOnly) {
				tiddlers.push(title);
			} else {
				tiddlers.push(store.getTiddler(title));
			}
		});
		return tiddlers;
	},
	refresh: function(listWrapper) {
		var checked = macro.getCheckedTiddlers(listWrapper, true);
		var paramString = $(listWrapper).empty().attr("params");
		var wizard = $.data(listWrapper, "wizard");
		var locale = macro.locale;
		var params = paramString.parseParams("anon")[0];
		var publishCandidates = [];
		var status = macro.getMode(paramString);
		var pubType = status[0];
		var newPubType = status[1];
		var tiddlers = params.filter ? store.filterTiddlers(params.filter[0]) :
			store.filterTiddlers("[is[%0]]".format(pubType));
		var enabled = [];
		for(var i = 0; i < tiddlers.length; i++) {
			var tiddler = tiddlers[i];
			var title = tiddler.title;
			if(!tiddler.tags.contains("excludePublisher") && title !== "SystemSettings") {
				publishCandidates.push({ title: title, tiddler: tiddler, status: pubType});
			}
			if(checked.contains(title)) {
				enabled.push("[rowname=%0]".format(title));
			}
		}

		if(publishCandidates.length === 0) {
			createTiddlyElement(listWrapper, "em", null, null, locale.noTiddlersText);
		} else {
			var listView = ListView.create(listWrapper, publishCandidates, macro.listViewTemplate);
			wizard.setValue("listView", listView);
			var btnHandler = function(ev) {
				var tiddlers = macro.getCheckedTiddlers(listWrapper);
				var callback = function(status) {
					$(".batchPublisher").each(function(i, el) {
						macro.refresh(el);
					});
				};
				macro.changeStatus(tiddlers, newPubType, callback);
			};
			wizard.setButtons([{
				caption: locale.changeStatusLabel.format(newPubType),
				tooltip: locale.changeStatusPrompt.format(newPubType),
				onClick: btnHandler
			}]);
			$(enabled.join(",")).attr("checked", true); // retain what was checked before
		}
	}
};

})(jQuery);
//}}}
Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a [[Design Review]], including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the [[DHF]]).
!Attention points
The FDA expects that each deviced designs is formally reviewed. The review should:
* Be performed by appriopriate design teams or individuals with review responsibility
* Occur at appropriate stages
* Include the design team participants that include representatives of all functions concerned with that design stage and at least one //''individual who does not havve a direct responsibility for the design stage being reviewed''// ([[Peer Review]])

The following deliverables should be subject to review:
* Schematics
* Device components
* Subassemblies
* Final [[Risk Analysis]] documents
* Final master [[Verification Plan]]
* Device manufacturing specifications and documentation
* Process validation protocol, if required
* Draft user, maintenance and service documentation
* Initiation of clinical trials if required
* Design and completion of any required integrity testing of the device packaging
* All documentation of verification actvities

Review meeting minutes should be created. Forms and checklists are also useful mechanisms. The may include:
* a [[Design Development Stage Identification Matrix]]
* Review and approval cover sheet
* Review checklists for each review stages
!Spaces
<<groupBy server.bag>>

!Private
<<list filter [is[private]]>>

!Public
<<list filter [is[public]]>>

!Drafts
<<list filter [is[draft]]>>
/***
|''Description''|Sanitisation for dynamically pulling tiddlers into your space and displaying them|
!Notes
Works both inside and outside TiddlyWiki. Uses the HTML Sanitizer provided by the Google Caja project
(see http://code.google.com/p/google-caja/wiki/JsHtmlSanitizer for more on this), which is licensed under
an Apache License (see http://www.apache.org/licenses/LICENSE-2.0).
!Code
***/
//{{{
(function($) {

var cleanURL = function(url) {
	var regexp = /^(?:http|https|mailto|ftp|irc|news):\/\//;
	return (regexp.test(url)) ? url : null;
};

$.sanitize = function(html) {
	return html_sanitize(html, cleanURL);
};

/*
 * HTML Sanitizer, provided by Google Caja
 */

/* Copyright Google Inc.
 * Licensed under the Apache Licence Version 2.0
 * Autogenerated at Tue May 17 17:39:24 BST 2011
 * @provides html4
 */var 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// stop here if we're not in TiddlyWiki
// XXX: is this the correct way of checking for TiddlyWiki?
if (!window.TiddlyWiki || !window.store || !store instanceof TiddlyWiki) {
	return;
}

var tiddlyspace = config.extensions.tiddlyspace;

var _subWikify = Wikifier.prototype.subWikify;

var cleanedTitle = 'This section has been cleaned of any potentially harmful code';

var replaceFunctions = {
	html: function(w) {
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			w.nextMatch = this.lookaheadRegExp.lastIndex;
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	},
	customFormat: function(w) {
		switch(w.matchText) {
			case '@@':
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				var styles = config.formatterHelpers.inlineCssHelper(w);
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				break;
		}
	}
};

Wikifier.prototype.subWikify = function(output, terminator) {
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			// external tiddler, so replace dangerous formatters
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		}
	} catch(e) {
		// do nothing. There's no tiddler, so assume it's safe (?!?!?)
	}

	_subWikify.apply(this, arguments);

	if (stripped) {
		// change back to the original function
		unstripHTML(stripped, this.formatter);
	}
};

// replace potentially unsafe formatters with versions that strip bad HTML/CSS
var stripHTML = function(tid, formatter) {
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	for (var i = 0; i < formatter.formatters.length; i++) {
		var f = formatter.formatters[i];
		if (replaceFunctions[f.name]) {
			_handler = f.handler;
			popped[f.name] = _handler;
			f.handler = replaceFunctions[f.name];
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	return popped;
};

// put the original formatters back where they belong
var unstripHTML = function(stripped, formatter) {
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		var f = formatter.formatters[i];
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	};
};

})(jQuery);
//}}}
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//(k) Displays of values of AKR and cumulative air kerma//

Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:
* (1) When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.
* (2) The cumulative air kerma in units of mGy shall be displayed either within 5 seconds of termination of an exposure or displayed continuously and updated at least once every 5 seconds.
* (3) The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.
* (4) The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope. The reference location shall be identified and described specifically in the information provided to users according to 1020.30(h)(6)(iii).
** (i) For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference locations shall be the respective locations specified in 1020.32(d)(3)(i), (d)(3)(ii), or (d)(3)(v) for measuring compliance with air-kerma rate limits.
** (ii) For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin.
* (5) Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.
* (6) The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than +/-35 percent over the range of 6 mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than 3 seconds.
Welcome to your brand new [[TiddlySpace]]@glossary.

To get started with this blank [[TiddlySpace]]@glossary, you'll need to modify the following [[tiddlers|Tiddler]]@glossary:
* If you don't like the color scheme click <<RandomColorPaletteButton>> to generate a new random acolor scheme.
* Upload a [[SiteIcon|SiteIcon tiddler]]@glossary. [[Your SiteIcon|SiteIcon]] gives your space an identity to make it recognisable to others. A good site icon will be square and at least 48*48 pixels size.
<<binaryUploadPublic title:SiteIcon>>
* [[SiteTitle]] & [[SiteSubtitle]]: The title and subtitle of the site, as shown above (after saving, they will also appear in the browser title bar)
* [[MainMenu]]: The menu (usually on the left)
* [[DefaultTiddlers]]: Contains the names of the tiddlers that you want to appear when the ~TiddlySpace is opened
* Many features of ~TiddlySpace are accessed via the backstage bar located at the top of the page. You can toggle it on or off using the button in the top right corner of the screen.
lso known als [[Not to file]]. Its a procedure that documents why a manfactures believes he is not eligible to file [[510(k)]]
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In FDA [[Design Controls|CFR 21-820.30 - Design Controls]]  ''//Risk Analysis//'' is the ongoing investigation of the available inormation to identify hazards and estimate their risk.
Sub System Risk Management Matrix
Class I Medical Devices are subject only to the FDA's [[General Controls]] because they are the least complicated and present the least risk. The FDA's general controls are though to provide reasonable asurance of the safe and effective use of these devices:
# Register manufacturing and distribution locations
# List&nbsp;device to be marketed&nbsp;with FDA
# Manufacture the devices in accordance with [[Good Manufacturing Practices]]
# Label medical devices in accordance with the labeling regulations, [[21 CFR 801|CFR 21-801 - Labeling]] or [[21 CFR 809]]
# Report adverse events&nbsp;of medical device&nbsp;as identified by the user, manufacturer and/or distributor
!Examples
Examples of Class I devices include tongue depressors, arm slings, and stethoscopes:
<<image /static/files/FDA/Example%20Class%20I.jpg width:600>>
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In probability theory and statistics, covariance is a measure of how much two variables change together.

$\Large {Cov}(X,Y) = {E}\big[X Y\big]  - {E}[X] \cdot {E}[Y]$

Where where ${E[}X]$ is the [[Expected Value]] of X. 
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Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
!Attention points
* Learn about what the FDA considers [[Production Specifications]]
* Particular care should be taken when the product involves new and unproved manufacturing processes, or established processes which are new to the manufacturer.
** It may not be possible to determine the adequacy of full-scale manufacturing on the basis of successfully building prototypes or models in a laboratory and testing these prototypes or models.
* No design team can anticipate all factors bearing on the success of the design, but procedures for design transfer should address at least the following basic elements.
** First, the design and development procedures should include a qualitative assessment of the completeness and adequacy of the [[Production Specifications]]
** Second, the procedures should ensure that all documents and articles which constitute the production specifications are reviewed and approved.
** Third, the procedures should ensure that only approved specifications are used to manufacture production devices.

The first item in the preceding list may be addressed during design transfer. The second and third elements are among the basic principles of [[Document Control]] and [[Configuration Management]].
In FDA Inspections Form 482, notice of inspections is the form the FDA presents to firms prior to an inspection. Typically this form is presented to the senior management individual available at the firm.

The form available at the FDA at the time of search can be found [[here|http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127428.pdf]]

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To understand FDA Inspections the following concepts & definitions are important during inspections:
* A [[Bottum-up inspection]] was the FDA standard inspection prior to 1998.
* [[Comprehensive inspection]] is an inspection on all elements of a firms quality system.
* [[Directed inspection]] is an inspection performed on specific elements of a firm's quality system.
* [[Establishment Inspection Report]], is a report completed by the FDA after an inspection.
* Form [[FDA 482]], is a notice of inspection.
* Form [[FDA 483]], contains the inspectional observations.
* [[Quality System Inspection Technique]] (QSIT) is the FDA's current inspection technique.
* A [[Table-Top Inspection]] is an inspection strategy of reviewing a firm's written procedures and records.
* A [[Top-Down Inspection]] is the FDA's latest inspection strategy in which inspectors are taught to evaluate the quality system and sampling quality system records
* [[Track I Inspection]] is a limitted inspection of the quality system conduced every two years
* [[Track II Inspection]] is a complete audit every four years
* [[Situation I]] conditions are those conditions that provide evidence that there are significant errors in the manufacturers production process leading to defective devices.
* [[Situation II]] conditions are those conditions that are not meeting the Situation I conditions.
* A [[Warning Letter]] is an administrative action typically issued to firms with Situation I conditions.

!Inspection frequency
The FDA does not need a warrant to inspect any device manufacturer. Refusal to permit the inspection is a violation of [[The Act]].

The following situations enter into the inspection assesment:
# Manufacturers whose last inspection was violative and who provided little or no compelling evidence of corrective measures
# Manufacures who received [[510(k)]] clearance for a high-risk device within the past 12 months and who have not been inspected within the previous 2 years.
# Manufacturers of class II and class III devices who have never been inspected
# Manufacturers who have newly registered
# Manufacturers with a recently cleared [[510(k)]]
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] a ''//[[Controlled Document]]//'' means a document subject to procedural control as well as review and approval by an appropriate individual or group.
''Production specifications'' must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities. One normally associates the term “production specifications” with written documents, such as assembly drawings, component procurement specifications, workmanship standards, manufacturing instructions, and inspection and test specifications.

While these types of documents are widely employed in medical device production, other equally acceptable means of conveying design information exist. For example, each of the following could constitute “production specifications” within the meaning of the quality system requirements:
* documentation (in electronic format as well as paper)
* training materials, e.g., manufacturing processes, test and inspection methods
* digital data files, e.g., programmable device files, master EPROM, computer-aided manufacturing (CAM) programming files
* manufacturing jigs and aids, e.g., molds, sample wiring harness to be duplicated
Each manufacturer shall establish and maintain a [[Design History File]] (DHF) for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
!Attention points
* Every section of the design control requirements specifies information which should be recorded.  The compilation of these records is sometimes referred to as the ''design history file''
* These diverse records need not be consolidated at a single location! There are ''no requirements on the location or organization of the design history file.''
** The intent is simply that manufacturers have access to the information when it is needed. 
** If a manufacturer has established procedures for multiple filing systems which together satisfy that intent, there is no need to create additional procedures or records.
* Example documents that can be part of the Design History File:
** The design controls procedures, forms and guidelines
** Executed forms that identify design control departments or activities
** Executed forms that identify design and development teams
** Executed forms that identify design and development interfaces
** Executed forms that identify design and development change requests
** All [[Product Proposals]]
** All general device requirements
** All [[Design Input Documentation Control Matrix]]es
** All detailed [[Design Input]] documents
** All [[Design Input Requirements Control Matrix]]es
** All [[Design Output Documentation Control Matrix]]es
** All general device specifications
** All [[Design Output Specifications Control Matrix]]es
** All detailed [[Design Output]] documents
** All design development stage identification
** All review and approval cover sheets
** All design review checklists
** All design review notes/minutes
** All master verification plans and design verification checklists
** All verification test plans
** All master validation plans and design validation checklists
** All validation test plans
** A copy of the [[Design Transfer Checklist]]
** All change requests and design change checklists
!Project size
Based on the structure (or lack thereof) of the product development organization, more or less extensive controls will be required:
* As design decisions often directly affect the well-being of device users and patients, it is to the manufacturer’s benefit to maintain the knowledge base which forms a basis for the product design.
** Quality system plans applicable to a development project may reside in the quality assurance department, while the chief engineer may be responsible for maintaining design and development plans.
** In some cases, especially for simple designs, the designer will assemble and maintain the entire design history file.
** For larger projects, a document control system will likely be established for design documents, and these files will likely be maintained in some central location, usually within the product development department
!Laboratory notebooks
* Company policy should state unequivocally that all design history documentation is the property of the manufacturer, not the employee or contractor.
** Design and development contracts should explicitly specify the manufacturer’s right to design information and establish standards for the form and content of design documentation.
** Finally, certain basic design information may be maintained in a single project file in a specified location.  This may include the following: 
** Detailed design and development plan specifying design tasks and deliverables.
** Copies of approved design input documents and design output documents.
**  Documentation of design reviews.
** Validation documentation.
** When applicable, copies of controlled design documents and change control records
* Many design engineers maintain laboratory notebooks which are typically retained in the engineers’ personal files.  In addition, the design history may include memoranda and electronic mail correspondence which are stored at various physical locations.
* As an example of the level of detail which may be entailed, some manufacturers have policies covering laboratory notebooks procedures which might address the following points.
** Laboratory notebooks are the property of the manufacturer, not the individual
** A separate notebook is to be maintained for each project, and surrendered to the engineering librarian at the conclusion of the engineer’s active participation in the project.
** Laboratory notebooks are to be surrendered if the employee leaves the company.
** Product development supervisors shall review employees’ laboratory notebooks at specified intervals to ensure that records are complete, accurate, and legible. *
NEN is a Dutch Standard published by the ”nederlands normalisatie instituut”
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Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
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Sec. 820.100 Corrective and preventive action.

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

# Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
# Investigating the cause of nonconformities relating to product, processes, and the quality system;
# Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
# Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
# Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
# Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
# Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.
7.3.7 Control of design and development changes

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
{{{
config.macros.PDF = {
  handler: function (place, macroName, params, wikifier, paramString, tiddler)
  {
     var url;

     if (params[0] != null)
     {
           url = params[0];
     }

     resultString = "<html>";
     resultString += '<iframe src ="http://docs.google.com/gview?url='
     resultString += url;
     resultString += ' &embedded=true" style="width:600px;height:340px;" frameborder="0"';
     resultString += '</iframe>'
     resultString += '</html>';

     wikify(resultString,place);
   }
 }
}}}
These regulations implement FDA's responsibility for and authority over each medical device's labeling. Labeling inclues all labels and other written, printed, or graphic matter on any device or its containers or wrappers or accompanying such devices and includes advertising matter and oral or written statements made by manufacturers or their representatives.
<<image /static/files/FDA/CFR%20801%20Labeling.jpg width:200>>
<!DOCTYPE html>
<html lang="en">
<head>
	<meta charset="utf-8"/>
	<title>TiddlySpace Apps</title>
	<link rel="stylesheet" href="/bags/common/tiddlers/reset.css" />
	<link rel="stylesheet" href="/bags/common/tiddlers/appspage.css" />
	<!--[if lt IE 7 ]>
	<link rel="stylesheet" href="/bags/common/tiddlers/appspageie6.css" />
	<![endif]-->
</head>
<body>
	
	<div id="wrapper">
		<div id="TSbar"></div>
		<div id="main-content">
			<div id="space-details">
				<a href="/_space"><img class="siteicon"></a>
				<div id="title-subtitle">
					<h1 class="spaceaddress">
						<span class="spaceName"></span><span class="hostName"></span>
					</h1>
					<p class="tagline"><span class="subTitle"></span><a class="managespaces" href="/_space">manage space</a></p>
				</div>
			</div>
			<div id="holder">
				<div id="appswitcher-wrapper">
					<div id="appswitcher">
						<h2>Your Apps</h2>
						<ul id="app-list">
							<li class="htmlserialisation">
								<a href="/tiddlers.html?select=tag:!excludeLists;sort=-modified">
									<img src="/bags/common/tiddlers/browse_read_blue.png" alt="Icon for the HTML Serialisation" class="app-img" />
									BROWSE
								</a>
							</li>
							<li class="tiddlywiki">
								<a href="/tiddlers.wiki">
									<img src="/bags/common/tiddlers/tiddlywiki2_blue.png" alt="Icon for TiddlyWiki" class="app-img" />
									TIDDLYWIKI
								</a>
							</li>
						</ul>
						<div id="addapp">
							<button class="inactive">Add More!</button>
						</div>
					</div>
					<div id="app-desc">
						<ul>
							<li class="htmlserialisationdesc"><p>an easy to understand HTML representation of your content.</p></li>
							<li class="tiddlywikidesc"><p>use TiddlyWiki to create, edit and organise your content.</p></li>
						</ul>
					</div>
					<div style="clear: both;"></div>
				</div>
			</div>
		</div>
		<div id="footer"><!-- ie doesn't support footer tag -->
			<div id="footer-content">
				<div class="links">
					<a href="http://blog.tiddlyspace.com">blog</a>
					<a href="http://featured.tiddlyspace.com">featured</a>
					<a href="http://docs.tiddlyspace.com">documentation</a>
					<a href="https://github.com/TiddlySpace/tiddlyspace">source</a>
				</div>
				<p>TiddlySpace 2011, created by <a href="http://osmosoft.com">Osmosoft</a></p>
			</div>
		</div>
	</div>
	
	<script type="text/javascript" src="/bags/common/tiddlers/backstage.js"></script>
	<script type="text/javascript" src="/bags/common/tiddlers/jquery.js"></script>
	<script type="text/javascript" src="/bags/tiddlyspace/tiddlers/chrjs"></script>
	<script type="text/javascript" src="/bags/common/tiddlers/chrjs-store.js"></script>
	<script type="text/javascript" src="/bags/common/tiddlers/jquery-json.js"></script>
	<script type="text/javascript" src="/bags/common/tiddlers/appspage.js"></script>
</body>
</html>
<!--{{{-->
<div id='headerFix'>
</div>
<div class='header'>
		<table width="100%">
<td width=30px></td>
			<td ALIGN=left>
				<span class='siteTitle' refresh='content' tiddler='SiteTitle'></span>
			</td>
			<td ALIGN=right>
				<span macro='search'></span>
			</td>
			<td> </td>
			<td> </td>
		</table>
</div>
<div id='menuBar'>
	<div id='mainMenu' refresh='content' tiddler='MainMenu'></div>
</div>
<div id='menuBarOptions'>
	<div id='sidebarOptions' refresh='content' tiddler='SideBarOptions'></div>
</div>
<div id='displayArea'>
	<div id='messageArea'></div>
	<div id='tiddlerDisplay'></div>
        <div id='sidebarTabs' refresh='content' force='true' tiddler='SideBarTabs'></div>
</div>
<!--}}}-->
PMA is an abreviation for [[Premarket approval]] and is required for [[Class II Medical Devices]]
A warning letter is an administrative action typically issued to firms with a [[Situation I]] condition identified on their [[FDA 483]] observations. Warning letters require a written repsonse from the firm within 15 working days.

Warning letters are normally received within 30 days of the firm's receipt of the from [[FDA 483]] observations.
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/***
|''Name:''|TiddlySpaceLinkPlugin|
|''Description:''|Formatter to reference other spaces from wikitext |
|''Author:''|PaulDowney (psd (at) osmosoft (dot) com) |
|''Source:''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/TiddlySpaceLinkPlugin.js|
|''Version:''|1.4.2|
|''License:''|[[BSD License|http://www.opensource.org/licenses/bsd-license.php]] |
|''Comments:''|Please make comments at http://groups.google.co.uk/group/TiddlyWikiDev |
|''~CoreVersion:''|2.4|
!!Documentation
This plugin provides wikitext formatters for referencing another [[space|Space]] on the same TiddlySpace server, as in the following examples:
<<<
  {{{@space}}} -- @space 
  {{{~@space}}} -- ~@space 
  {{{Tiddler@space}}} -- Tiddler@space
  {{{[[Tiddler Title]]@space}}} -- [[Tiddler Title]]@space 
  {{{[[Link text|Tiddler Title]]@space}}} -- [[Link text|Tiddler Title]]@space
<<<
Links to tiddlers with a title begining with an "@" remain as tiddlyLinks:
<<<
  {{{[[@tiddler]]}}} -- [[@tiddler]]
<<<
and these may be changed into a space link using {{{@@}}}:
<<<
  {{{[[@@space]]}}} -- [[@@space]]
  {{{[[Link to an another space|@@space]]}}} -- [[Link to another space|@@space]]
  {{{[[@space|@@space]]}}} -- [[@space|@@space]]
<<<
TiddlySpace includes the [[TiddlySpaceLinkPlugin]] which provides WikiText markup for linking to other spaces on the same server. For example @glossary is a link to the {{{glossary}}} space and [[Small Trusted Group]]@glossary a link to an individual tiddler in the @glossary space. Prefixing the link with a tilde escapes the link, for example {{{~@space}}}.
Email addresses, for example joe.bloggs@example.com and mary@had.a.little.lamb.org should be unaffected.
!!Features
The plugin provides external links decorated so that other plugins may be included to add features such as the ability to dynamically pull externally linked tiddlers into the current TiddlyWiki.
Wikitext linking to a space on another server, for example from a tiddler in a space on tiddlyspace.com to a tiddler or a space on example.com, isn't currently supported. 
!!Code
***/
//{{{
/*jslint onevar: false nomen: false plusplus: false */
/*global jQuery config createTiddlyText createExternalLink createTiddlyLink */

function createSpaceLink(place, spaceName, title, alt, isBag) {
	var link, a, currentSpaceName, label;
	try {
		if (spaceName === config.extensions.tiddlyspace.currentSpace.name) {
			title = title || spaceName;
			a = createTiddlyLink(place, title, false);
			jQuery(a).text(alt || title);
			return a;
		}
	} catch (ex1) {
		currentSpaceName = false;
	}

	a = jQuery("<a />").addClass('tiddlySpaceLink externalLink').appendTo(place)[0];
	if(title) {
		jQuery(a).attr('tiddler', title);
	}
	if(isBag) {
		jQuery(a).attr('bag', spaceName);
	} else {
		jQuery(a).attr('tiddlyspace', spaceName);
	}

	config.extensions.tiddlyweb.getStatus(function(status) {
		link = status.server_host.url;
		if (title) {
			label = alt || title;
			link = link + "/" + encodeURIComponent(title);
		} else {
			label = alt || spaceName;
		}
		// assumes a http URI without user:pass@ prefix
		if(!isBag) {
			link = link.replace("http://", "http://" + spaceName.toLowerCase() + ".");
		} else {
			link += "/bags/" + spaceName + "/tiddlers.wiki";
		}
		jQuery(a).attr("href", link).text(label);
	});
	return a;
}

(function ($) {

	config.textPrimitives.spaceName = "[a-zA-Z][a-zA-Z0-9-]*[a-zA-Z0-9]";
	config.textPrimitives.spaceNameStrict = "[a-z][a-z0-9-]*";
	config.textPrimitives.bareTiddlerLetter = config.textPrimitives.anyLetterStrict;

	config.formatters.splice(0, 0, {
		name: "spacenameLink",
		match: config.textPrimitives.unWikiLink + "?" + config.textPrimitives.bareTiddlerLetter + "*@" + config.textPrimitives.spaceName + "\\.?.?",
		lookaheadRegExp: new RegExp(config.textPrimitives.unWikiLink + "?(" + config.textPrimitives.bareTiddlerLetter + "*)@(" + config.textPrimitives.spaceName + ")", "mg"),
		handler: function (w) {
			if (w.matchText.substr(w.matchText.length - 2, 1) === '.' && w.matchText.substr(w.matchText.length - 1, 1).match(/[a-zA-Z]/)) {
				w.outputText(w.output, w.matchStart, w.nextMatch);
				return;
			}
			if (w.matchText.substr(0, 1) === config.textPrimitives.unWikiLink) {
				w.outputText(w.output, w.matchStart + 1, w.nextMatch);
				return;
			}
			this.lookaheadRegExp.lastIndex = w.matchStart;
			var lookaheadMatch = this.lookaheadRegExp.exec(w.source);
			if (lookaheadMatch && lookaheadMatch.index === w.matchStart) {
				createSpaceLink(w.output, lookaheadMatch[2], lookaheadMatch[1]);
				w.nextMatch = this.lookaheadRegExp.lastIndex;
			}
		}
	},
	{
		name: "tiddlySpaceLink",
		match: "\\[\\[[^\\|\\]]*\\|*@@" + config.textPrimitives.spaceName + "\\]",
		lookaheadRegExp: new RegExp("\\[\\[(.*?)(?:\\|@@(.*?))?\\]\\]", "mg"),
		handler: function (w) {
			this.lookaheadRegExp.lastIndex = w.matchStart;
			var lookaheadMatch = this.lookaheadRegExp.exec(w.source);
			if (lookaheadMatch && lookaheadMatch.index === w.matchStart) {
				var alt = lookaheadMatch[2] ? lookaheadMatch[1] : lookaheadMatch[1].replace(/^@@/, "");
				var space = lookaheadMatch[2] || alt;
				createSpaceLink(w.output, space, "", alt);
				w.nextMatch = this.lookaheadRegExp.lastIndex;
			}
		}
	},
	{
		name: "tiddlyLinkSpacenameLink",
		match: "\\[\\[[^\\[]*\\]\\]@",
		lookaheadRegExp: new RegExp("\\[\\[(.*?)(?:\\|(.*?))?\\]\\]@(" + config.textPrimitives.spaceName + ")", "mg"),
		handler: function (w) {
			this.lookaheadRegExp.lastIndex = w.matchStart;
			var lookaheadMatch = this.lookaheadRegExp.exec(w.source);
			if (lookaheadMatch && lookaheadMatch.index === w.matchStart) {
				var title = lookaheadMatch[2] || lookaheadMatch[1];
				var alt = lookaheadMatch[1] || lookaheadMatch[2];
				createSpaceLink(w.output, lookaheadMatch[3], title, alt);
				w.nextMatch = this.lookaheadRegExp.lastIndex;
			}
		}
	});

	// ensure space links don't appear as missing links
	config.textPrimitives.brackettedLink = "\\[\\[([^\\]][^@\\]][^\\]]*)\\]\\](?=[^@])";
	config.textPrimitives.titledBrackettedLink = "\\[\\[([^\\[\\]\\|]+)\\|([^\\[\\]\\|]+)\\]\\](?=[^@])";

	// reevaluate derrived expressions ..
	config.textPrimitives.tiddlerForcedLinkRegExp = new RegExp("(?:" + config.textPrimitives.titledBrackettedLink + ")|(?:" +
		config.textPrimitives.brackettedLink + ")|(?:" +
		config.textPrimitives.urlPattern + ")","mg");
	config.textPrimitives.tiddlerAnyLinkRegExp = new RegExp("("+ config.textPrimitives.wikiLink + ")|(?:" +
		config.textPrimitives.titledBrackettedLink + ")|(?:" +
		config.textPrimitives.brackettedLink + ")|(?:" +
		config.textPrimitives.urlPattern + ")","mg");

	// treat space links in titledBracketedLink as external links
	var missingTiddlySpaceLink = new RegExp("^@@" + config.textPrimitives.spaceName + "$", "");
	var isExternalLink = config.formatterHelpers.isExternalLink;
	config.formatterHelpers.isExternalLink = function(link) {
		return missingTiddlySpaceLink.test(link) || isExternalLink(link);
	};

}(jQuery));
//}}}
//(4) Exemptions//
Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in paragraph (d) of this section.
''Responsibility and authority''

Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.

Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the ''//independence//'' and authority necessary to perform these tasks.

NOTE National or regional regulations might require the nomination of specific persons as responsible for activities
related to monitoring experience from the post-production stage and reporting adverse events (see 8.2.1 and 8.5.1).
//(1)(i) Fluoroscopic equipment manufactured before June 10, 2006//

* Shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube.
** The maximum cumulative time of the timing device shall not exceed 5 minutes without resetting.
** A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation-time. 
** Such signal shall continue to sound while x-rays are produced until the timing device is reset.
** Fluoroscopic equipment may be modified in accordance with 1020.30(q) to comply with the requirements of 1020.32(h)(2).
** When the equipment is modified, it shall bear a label indicating the statement:
** ''Modified to comply with 21 CFR 1020.32(h)(2).''

* (ii) As an alternative to the requirements of this paragraph, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.
Read the official FDA guidance to design controls [[here|http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf]]. The CFR regulations described with respect to Design Controls are:
<<forEachTiddler
    where
        'tiddler.tags.contains("CFR 21-820.30") && tiddler.tags.contains("Section")'
    sortBy 
         'tiddler.title.toUpperCase()'
   write
         '"* [["+tiddler.title+"]]" + "\n"'
>>
! Overview of Medical Device Design and its Control

<<image /static/files/FDA/82030a.jpg width:400>>

!Terms

<<forEachTiddler
 where
 'tiddler.tags.contains("Term") && tiddler.tags.contains("CFR 21-820.30")'
 sortBy 
        'tiddler.title.toUpperCase()'
 script
 '
 function getFirstLine(s) {
 var m = s.match(/\s*(.*)/);
 return m != null && m.length >= 1 ? m[1] : "";
 }
 '
 write
 '"|[["+tiddler.title+"]]"+"|"+ getFirstLine(tiddler.text)+"|\n"' 

>>
Book tips on this subject:
<<forEachTiddler
    where
        'tiddler.tags.contains("Book")'
    sortBy 
         'tiddler.title.toUpperCase()'
 script
 '
 function getFirstLine(s,a,rc,rt) {
 var r = "";
 var m = s.match(/\s*(.*)/);
 if (a == undefined)
 {
    r = m != null && m.length >= 1 ? m[1] : ""
 }
 else
 {
   r = "Author: " + a;
 }
if (rc == undefined)
{
  r = r + ", @@color(red):Not read yet@@";
}
else
{
  if (rc == true)
  {
    r = r + ", \'\'@@color(green):Completed@@\'\'";
  }
  else
  {
    r = r + ", To read";
  }
}
if (rt == undefined)
{
  r = r + ", not rated";
}
else
{
    r = r + ", @@color(green):" + rt + "@@";
}


 return (r);
 }
 '
 write
 '"* [["+tiddler.title+"]]"+", \/\/"+ getFirstLine(tiddler.text, tiddler.data("Author"), tiddler.data("ReadingCompleted"), tiddler.data("Rating"))+"\/\/\n"' 
>>

<<newTiddlerWithForm NewBookTemplate "New book"  '"Title"' askUser>>
In the FDA's Quality System Requirements ''Management with executive responsibility'' means those senior employees of a manufacturer who have the authority to [[Establish]] or make changes to the manufacturer's quality policy and [[Quality System]]
7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Validation shall be completed prior to the delivery or implementation of the product (see Note 1).

Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

As part of design and development validation, the organization shall perform clinical evaluations and/or evaluation of performance of the medical device, as required by national or regional regulations (see Note 2).

NOTE 1 If a medical device can only be validated following assembly and installation at point of use, delivery is not considered to be complete until the product has been formally transferred to the customer.

NOTE 2 Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is not
considered to be delivery.
/***
|''Name''|TiddlySpaceToolbar|
|''Description''|augments tiddler toolbar commands with SVG icons|
|''Author''|Osmosoft|
|''Version''|0.6.6|
|''Status''|@@beta@@|
|''Source''|http://github.com/TiddlySpace/tiddlyspace/raw/master/src/plugins/TiddlySpaceToolbar.js|
|''CodeRepository''|http://github.com/TiddlySpace/tiddlyspace|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
|''CoreVersion''|2.5.0|
|''Requires''|ImageMacroPlugin|
|''Keywords''|toolbar icons SVG|
!Description
replaces tiddler toolbar commands with SVG icons if available
!Notes
requires [[ImageMacroPlugin|http://svn.tiddlywiki.org/Trunk/contributors/JonRobson/plugins/ImageMacroPlugin/plugins/ImageMacroPlugin.tid]]

SVG icons are drawn from tiddlers titled {{{<command>.svg}}}
In readonly mode a tiddler called {{{<command>ReadOnly.svg}}} will be used if it exists.
!TODO
* rename (IconToolbarPlugin?)
* support more than one more popup menu in the toolbar.
!Code
***/
//{{{
(function($) {

if(!config.macros.image) {
	throw "Missing dependency: ImageMacroPlugin";
}

var macro = config.macros.toolbar;

macro.icons = {
	cloneTiddler: "editTiddler"
};

var _handler = macro.handler;
macro.handler = function(place, macroName, params, wikifier,
		paramString, tiddler) {
	var toolbar = $(place);
	toolbar.attr({
		refresh: "macro",
		macroName: macroName
	}).data("args", arguments);
	var status = _handler.apply(this, arguments);
	if(tiddler.isReadOnly()) {
		toolbar.addClass("toolbarReadOnly");
	} else {
		toolbar.removeClass("toolbarReadOnly");
	}
	var parsedParams = paramString.parseParams("name")[0];
	if(parsedParams.icons && parsedParams.icons == "yes") {
		this.augmentCommandButtons(place);
	}
	if(parsedParams.more && parsedParams.more == "popup") {
		// note we must override the onclick event like in createTiddlyButton
		// otherwise the click event is the popup AND the slider
		$(".moreCommand", place).each(function(i, el) {
			el.onclick = macro.onClickMorePopUp;
		});
		// buttons that are after a less command should not be in more menu.
		$(".lessCommand ~ .button", place).appendTo(place);
		$(".lessCommand", place).remove();
	}
	return status;
};

macro.refresh = function(place, params) {
	var args = $(place).empty().data("args");
	this.handler.apply(this, args);
};

var imageMacro = config.macros.image;
macro.augmentCommandButtons = function(toolbar) {
	$(".button", toolbar).each(function(i, el) {
		var cmd = $(el).attr("commandname");
		cmd = cmd ? cmd : "moreCommand"; // XXX: special-casing of moreCommand due to ticket #1234
		var icon = store.tiddlerExists(cmd) ? cmd : macro.icons[cmd];
		var text = $(el).text();
		if(readOnly) {
			var readOnlyAlternative = "%0ReadOnly".format([icon]);
			if(store.tiddlerExists(readOnlyAlternative)) {
				icon = readOnlyAlternative;
			}
		}
		if(store.tiddlerExists(icon)) {
			$(el).css({display: "inline-block"}).empty();
			imageMacro.renderImage(el, icon, { alt: text });
		}
	});
};

// provide onClickMore to provide extra commands in a popup
macro.onClickMorePopUp = function(ev) {
	ev = ev || window.event;
	var sibling = this.nextSibling;
	if(sibling) {
		var commands = sibling.childNodes;
		var popup = Popup.create(this);
		$(popup).addClass("taggedTiddlerList");
		for(var i = 0; i < commands.length; i++) {
			var li = createTiddlyElement(popup, "li", null);
			var oldCommand = commands[i];
			var command = oldCommand.cloneNode(true);
			command.onclick = oldCommand.onclick;
			li.appendChild(command);
		}
		Popup.show();
	}
	ev.cancelBubble = true;
	if(ev.stopPropagation) {
		ev.stopPropagation();
	}
	return false;
};

})(jQuery);
//}}}
These regulations implement the FDA's responsibilities for and authority over
# Medical devices that are permanently implanted or life sustaining or life supporting
# Any other device that the agency may designate
The FDA Modernization Act [[FDAMA]] removed the mandatory tracking requiement and limited FDA's discretionairt authority to require tracking only to class II and class III devices that are:
# Reasonably likely to have serious adverse health consequences upon failure of the device
# Intended to be implanted for over one year
# Life sustaining or life supporting and intended for use outside a device user facility
/***
|''Name:''|FCKeditorPlugin|
|''Description:''|Wysiwyg editor for TiddlyWiki using FCKeditor.|
|''Version:''|1.1.1|
|''Date:''|Dec 21,2007|
|''Source:''|http://visualtw.ouvaton.org/VisualTW.html|
|''Author:''|Pascal Collin|
|''License:''|[[BSD open source license|License]]|
|''~CoreVersion:''|2.2.0|
|''Browser:''|Firefox 2.0; InternetExplorer 6.0, others|
!Demo:
On the plugin [[homepage|http://visualtw.ouvaton.org/VisualTW.html]], see and edit [[WysiwygDemo]].
!Installation:
#download and unzip [[FCKeditor|http://www.fckeditor.net/download]] (by default, in a wiki subfolder, such that the relative path "fckeditor/fckeditor.js" is right).
#import [[FCKeditorPlugin]] (systemConfig tagged)
#add the following text to MarkupPreHead : {{{<script type="text/javascript" src="fckeditor/fckeditor.js"></script>}}}
#customize FCKeditorPath if needed (in MarkupPreHead and in options below)
#save and reload
#use the <<toolbar editHtml>> button in the tiddler's toolbar (in default ViewTemplate) or add {{{editHtml}}} command in your own toolbar.
! Useful Addons
*[[HTMLFormattingPlugin|http://www.tiddlytools.com/#HTMLFormattingPlugin]] to embed wiki syntax in html tiddlers.<<br>>//__Tips__ : When this plugin is installed, you can use anchor syntax to link tiddlers in wysiwyg mode (example : #example). Anchors are converted back and from wiki syntax when editing.//
*[[TaggedTemplateTweak|http://www.TiddlyTools.com/#TaggedTemplateTweak]] to use alternative ViewTemplate/EditTemplate for tiddler's tagged with specific tag values.
!Configuration options :
|FCKeditor folder (absolute or relative)|<<option txtFCKeditorPath>> |
|FCKeditor custom configuration script path (relative or absolute)<<br>>[[Example|fckeditor/editor/custom_config.js]] : {{{ fckeditor/editor/custom_config.js}}}|<<option txtFCKCustomConfigScript>>|
|Toolbar name ("Default", "Basic" or custom)<<br>>See [[FCKeditor documentation|http://wiki.fckeditor.net/Developer%27s_Guide/Configuration/Toolbar]] for more information on custom toolbars|<<option txtFCKToolbar>>|
|FCKeditor default height (if blank = 500px)|<<option txtFCKheight>>|
|Template called by the {{{wysiwyg}}} button|EditHtmlTemplate|
!Code
***/
//{{{
config.options.txtFCKeditorPath = config.options.txtFCKeditorPath ? config.options.txtFCKeditorPath : "/static/fckeditor/";
config.options.txtFCKCustomConfigScript = config.options.txtFCKCustomConfigScript ? config.options.txtFCKCustomConfigScript : "";
config.options.txtFCKToolbar = config.options.txtFCKToolbar ? config.options.txtFCKToolbar : "";
config.options.txtFCKheight = config.options.txtFCKheight ? config.options.txtFCKheight : "500px";

config.macros.editHtml = {
	handler : function(place,macroName,params,wikifier,paramString,tiddler) {
		var field = params[0];
		var height = params[1] ? params[1] : config.options.txtFCKheight;
		if (typeof FCKeditor=="undefined"){
			displayMessage(config.macros.editHtml.FCKeditorUnavailable);
			config.macros.edit.handler(place,macroName,params,wikifier,paramString,tiddler);

		}
		else if (field) {
			var e = createTiddlyElement(null,"div");
			var fckName = "FCKeditor"+ Math.random();
			if(tiddler.isReadOnly())
				e.setAttribute("readOnly","readOnly");
			e.setAttribute("editHtml",field);
			if (height) e.setAttribute("height",height);
			e.setAttribute("fckName",fckName);
			place.appendChild(e);
			var fck = new FCKeditor(fckName);
			fck.BasePath = config.options.txtFCKeditorPath;
			if (config.options.txtFCKCustomConfigScript) fck.Config["CustomConfigurationsPath"] = config.options.txtFCKCustomConfigScript ;
			if (config.options.txtFCKToolbar) fck.ToolbarSet = config.options.txtFCKToolbar;
			fck.Height=height;
			var re = /^<html>(.*)<\/html>$/m;
			var fieldValue=store.getValue(tiddler,field);
			var htmlValue = re.exec(fieldValue);
			var value = (htmlValue && (htmlValue.length>0)) ? htmlValue[1] : fieldValue;
			value=value.replace(/\[\[([^|\]]*)\|([^\]]*)]]/g,'<a href="#$2">$1</a>');
			config.macros.editHtml.FCKvalues[fckName]=value;
			e.innerHTML = fck.CreateHtml();
		}
	},
        gather : function(e) {
            var name = e.getAttribute("fckName");
            var oEditor = window.FCKeditorAPI ? FCKeditorAPI.GetInstance(name) : null;
            if (oEditor) {
                        var html = oEditor.GetHTML();
			if (html!=null) 
                                    return "<html>"+html.replace(/<a href="#([^>]*)">([^<]*)<\/a>/gi,"[[$2|$1]]")+"</html>"; 
            }	
        },
	FCKvalues : {},
	FCKeditorUnavailable : "FCKeditor was unavailable. Check plugin configuration and reload."
}


window.FCKeditor_OnComplete= function( editorInstance ) {
        var name=editorInstance.Name;
	var value = config.macros.editHtml.FCKvalues[name];
	delete config.macros.editHtml.FCKvalues[name];
	oEditor = FCKeditorAPI.GetInstance(name);
	if (value) oEditor.SetHTML(value);
}

Story.prototype.previousGatherSaveEditHtml = Story.prototype.previousGatherSaveEditHtml ? Story.prototype.previousGatherSaveEditHtml : Story.prototype.gatherSaveFields; // to avoid looping if this line is called several times
Story.prototype.gatherSaveFields = function(e,fields){
	if(e && e.getAttribute) {
		var f = e.getAttribute("editHtml");
		if(f){
			var newVal = config.macros.editHtml.gather(e);
			if (newVal) fields[f] = newVal;
		}
		this.previousGatherSaveEditHtml(e, fields);
	}
};

config.shadowTiddlers.EditHtmlTemplate = config.shadowTiddlers.EditTemplate.replace(/macro='edit text'/,"macro='editHtml text'");

config.commands.editHtml={
	text: "wysiwyg",
	tooltip: "Edit this tiddler with a rich text editor",
	readOnlyText: "",
	handler : function(event,src,title) {
		clearMessage();
		var tiddlerElem = document.getElementById(story.idPrefix + title);
		var fields = tiddlerElem.getAttribute("tiddlyFields");
		story.displayTiddler(null,title,"EditHtmlTemplate",false,null,fields);
		return false;
	}
}

config.shadowTiddlers.ViewTemplate = config.shadowTiddlers.ViewTemplate.replace(/\+editTiddler/,"+editTiddler editHtml");

//}}}
Premarket notification or [[510(k)]] is a process by which a submitter notifies the FDA at least 90 days prior to the submitters inroduction of any appropriate device (some Class I and most Class II devices) into interstate commerce. The submission must include a product classification based on safety and effectiveness. Based on the information and the date submitted, the FDA determines whether the product is substantially equivalent to a legally marketed predicate device. When the FDA makes that finding, the submitter is notified and may market the device. These submissions are called [[510(k)]]s because the report submission requirement is identifies in the Act under this section number

See: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
<!--{{{-->
<div class='toolbar'
	macro='toolbar [[ToolbarCommands::EditToolbar]] icons:yes'>
</div>
<div class='heading editorHeading'>
	<div class='editor title' macro='edit title'></div>
	<div class='tagClear'></div>
</div>
<div class='annotationsBox' macro='annotations'>
	<div class='editSpaceSiteIcon'
		macro='tiddlerOrigin height:16 width:16 label:no interactive:no'>
	</div>
	<div class="privacyEdit" macro='setPrivacy label:no interactive:no'></div>
	<div class='tagClear'></div>
</div>
<div class='editor' macro='edit text'></div>
<div class='editorFooter'>
	<div class='tagTitle'>tags</div>
	<div class='editor' macro='edit tags'></div>
	<div class='tagAnnotation'>
		<span macro='message views.editor.tagPrompt'></span>
		<span macro='tagChooser excludeLists'></span>
	</div>
</div>
<!--}}}-->
These regulations implement the FDA's responsibilities for and authority over the establishment, amendment and revocation of performance standards for medical devices. Congress intended performance standards to be a means of establishing generic premarket review of devices by defining requirements for devices that, when met, would reasonably assure safe and effective devices.
/***
|''Name''|RandomColorPalettePlugin|
|''Description''|Adds a random color palette to TiddlyWiki|
|''Author''|Jon Robson|
|''Version''|1.4.0|
|''Status''|stable|
|''Source''|https://github.com/jdlrobson/TiddlyWikiPlugins/raw/master/plugins/RandomColorPalettePlugin/RandomColorPalettePlugin.js|
|''License''|[[BSD|http://www.opensource.org/licenses/bsd-license.php]]|
!Usage
{{{
<<RandomColorPalette>>
}}}
Sets and saves a random color palette on execution

{{{
<<RandomColorPaletteButton>>
}}}
Creates a button, which when clicked will change the color palette
More information at http://macros.tiddlyspace.com/#%5B%5BRandomColorPaletteButton%20macro%5D%5D
!Code
***/
//{{{
RGB.prototype.toRGBString = function() {
	return "rgb(%0,%1,%2)".format(parseInt(this.r * 255, 10),
		parseInt(this.g * 255, 10), parseInt(this.b * 255, 10))
}
function HSL_TO_RGB(h, s, l) { // h (hue) between 0 and 360, s (saturation) & l (lightness) between 0 and 1
	var c = l <= 0.5 ? 2 * l * s : ( 2 - (2 * l)) * s;
	var h1 = h / 60;
	var x = c * (1 - Math.abs((h1 % 2) - 1)); 
	var r, g, b;
	if(typeof(h) == 'undefined') {
		r = 0;
		g = 0;
		b = 0;
	} else if(0 <= h1 && h1 < 1) {
		r = c;
		g = x;
		b = 0;
	} else if(1 <= h1 && h1 < 2) {
		r = x;
		g = c;
		b = 0;
	} else if(2 <= h1 && h1 < 3) {
		r = 0;
		g = c;
		b = x;
	} else if(3 <= h1 && h1 < 4) {
		r = 0;
		g = x;
		b = c;
	} else if(4 <= h1 && h1 < 5) {
		r = x;
		g = 0;
		b = c;
	} else if(5 <= h1 && h1 < 6) {
		r = c;
		g = 0;
		b = x;
	}
	m = l - (0.5 * c);
	return new RGB(r + m, g + m, b + m);
}

(function($){
	var macro = config.macros.RandomColorPalette = {
		messagesOn: false, 
		changedPaletteText: "We have assigned you a random theme by adjusting the [[ColorPalette]] tiddler.\nDon't like it? Click <<RandomColorPalette>> for another one.", 
		handler: function(place, macroName, params, wikifier, paramString, tiddler) {
			paramString = paramString || "";
			var options = macro.getOptions(paramString);
			macro.generatePalette(options, true);
		},
		optionTypes: {
			floats: ["hue", "saturation", "darkest", "lightness", "huevariance", "dark", "pale", "light", "mid",
				"saturation_light", "saturation_pale", "saturation_mid", "saturation_dark"
			]
		},
		getOptions: function(paramString) {
			var args = paramString.parseParams("name", null, true, false, true)[0];
			var options = {};
			var numbers = macro.optionTypes.floats;
			for(var i in args) {
				options[i] = numbers.indexOf(i) > -1 ? parseFloat(args[i][0], 10) : args[i][0];
			}
			return options;
		},
		generateRandomNumber: function(min, max, info) {
			var num = (Math.random() * 1);
			info = !info ? { attempts:0 } : info;
			info.attempts += 1;
			var good = true;
			if(min == max) {
				return max;
			}
			if(min && num < min) {
				good = false;
			} else if(max && num > max) {
				good = false;
			}
			if(!good) {
				if(info.attempts < 5) {
					return macro.generateRandomNumber(min, max, info);
				} else {
					if(max) {
						return max;
					} else if(min) {
						return min;
					} else {
						return 1;
					}
				}
			}
			return num;
		},
		getExistingPalette: function(asJSON) {
			var title = "ColorPalette";
			var tiddlerText;
			if(store.tiddlerExists(title)) {
				tiddlerText = store.getTiddlerText(title);
			} else if(store.isShadowTiddler(title)){
				tiddlerText = config.shadowTiddlers[title];
			}
			if(asJSON) {
				var json = {};
				if(tiddlerText) {
					var lines = tiddlerText.split("\n");
					for(var i = 0; i < lines.length; i++) {
						var definition = lines[i].split(":");
						if(definition.length == 2) {
							var name = definition[0].trim();
							var value = definition[1].trim();
							json[name] = value;
						}
					}
				}
				return json;
			} else {
				return tiddlerText;
			}
		},
		generatePalette: function(options, save) {
			var outputRGB = options.rgb;
			var palette = macro.getExistingPalette(true);
			var hue = options.hue || Math.floor(Math.random() * 359);
			var saturation = options.saturation || macro.generateRandomNumber(0.3, 0.7);
			var dark = options.dark || options.darkest || macro.generateRandomNumber(0, 0.10);
			var pale = options.pale || options.lightness || macro.generateRandomNumber(0.90, 1);
			var delta = ( ( pale - dark ) / 3 );
			var mid = options.mid || dark + delta;
			var light = options.light || dark + (delta * 2);
			var lightness_values = {Dark: dark, Mid: mid, Light: light, Pale: pale};
			var saturation_values = {};
			for(i in lightness_values) {
				if(true) {
					saturation_values[i] = options["saturation_" + i.toLowerCase()] || saturation;
				}
			}

			var opposite_hue = (hue + 180) % 360;
			var seed = options.huevariance || Math.floor((85 * Math.random()) + 5); // we want it to be at least 5 degrees
			var huetwo = (opposite_hue + seed) % 360;
			var huethree = (opposite_hue - seed) % 360;
			if(huetwo < 0) {
				huetwo = 360 + huetwo;
			}
			if(huethree < 0) {
				huethree = 360 + huethree;
			}
			for(var j in lightness_values) {
				if(true) {
					var saturation = saturation_values[j];
					palette["Primary" + j] = HSL_TO_RGB(hue, saturation, lightness_values[j]);
					palette["Secondary" + j] = HSL_TO_RGB(huetwo, saturation, lightness_values[j]);
					palette["Tertiary" + j] = HSL_TO_RGB(huethree, saturation, lightness_values[j]);
				}
			}
			palette.Background = HSL_TO_RGB(hue, saturation, 0.92);
			palette.Foreground = HSL_TO_RGB(hue, saturation, 0.08);
			palette.ColorPaletteParameters = ["HSL([", hue, "|", seed, "], [", saturation_values.Pale, "|",
				saturation_values.Light, "|", saturation_values.Mid, "|", saturation_values.Dark, "],",
				"[", dark, "|", mid, "|", light, "|", pale, "])"].join("");
			// construct new ColorPalette
			var text = ["/*{{{*/\n"];
			var colorcode;
			for(var id in palette) {
				if(true) {
					var color = palette[id];
					colorcode = outputRGB ? color.toRGBString() : color.toString();
					text.push("%0: %1\n".format(id, colorcode));
				}
			}
			text.push("/*}}}*/");
			text = text.join("");
			if(save) {
				macro.saveColorPalette(text);
			}
			return text;
		},
		saveColorPalette: function(text) {
			var tid = store.getTiddler("ColorPalette");
			if(!tid) {
				tid = new Tiddler("ColorPalette");
				tid.fields = merge({}, config.defaultCustomFields);
			} // TODO: detect that the ColorPalette in the space comes from outside recipe
			tid.fields["server.page.revision"] = "false"; // edit conflicts dont matter

			// save the color palette in tid
			tid = store.saveTiddler(tid.title, tid.title, text, tid.modifier, tid.modified,
				tid.tags, tid.fields, false, tid.created, tid.creator);
			// an interval is used to cope with users clicking on the palette button quickly.
			if(macro._nextSave) {
				window.clearTimeout(macro._nextSave);
			}
			macro._nextSave = window.setTimeout(function() {
					autoSaveChanges(null, [tid]);
				}, 2000);
			// temporary workaround for IE.
			$.twStylesheet.remove({ id: "StyleSheetColors" });
			$.twStylesheet.remove({ id: "StyleSheet" });
			refreshAll();
			macro.reportChange();
			return tid;
		},
		reportChange: function() {
			if(macro.messagesOn) { // only display message once..
				var msgPlace = getMessageDiv();
				if(!$(".changedPalette", msgPlace)[0]) {
					var tempPlace = document.createElement("div");
					wikify("{{changedPalette{" + macro.changedPaletteText + "}}}", tempPlace);
					msgPlace.appendChild(tempPlace);
				}
			}
		}
	};
	var btnMacro = config.macros.RandomColorPaletteButton = {
			text: "New ColorPalette",
			tooltip: "Generate a random colour scheme for your TiddlyWiki",
			makeButton: function(place, options) {
				var btnHandler = function(ev) {
					var t = $(ev.target);
					var options = t.data("options");
					macro.generatePalette(options, true);
					ev.preventDefault();
					return false;
				};
				var btn = createTiddlyButton(place, this.text, this.tooltip, btnHandler);
				$(btn).data("options", options);
				return btn;
			},
			handler: function(place, macroName, params, wikifier, paramString, tiddler) {
				var options = macro.getOptions(paramString);
				btnMacro.makeButton(place, options);
			}
	};
})(jQuery);
//}}}
''4.2.2 Quality manual''

The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusion and/or non-application (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

The [[Quality Manual]] shall outline the structure of the documentation used in the quality management system
These regulations implement the FDA's responsibilities for and authority over classification of devices.

<<tiddler [[Device classification]]>>
Each manufacturer shall establish a [[Quality Plan]] which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

!Attention Points
* Establishing how requirements are met is typically achieved in individual appropriate procedures
* During [[management review|CFR 21.820c - Management review]] quality planning should be briefly discussed and their corrective actions should be identifies.

Any quality plan should reference existing system documentation.


<<image /static/files/FDA/Quality%20Plan.jpg width:300>>
Verification test plans are created following the master test plan to ensure that each new or modified device is appriopiate for its intended use and approved prior to implementation.
The form FDA 483, Notice of inspection os the form the FDA present to firms as the conclusions of an inspection. You can find the form [[here|http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127434.pdf]]

Form FDA 483 observations are considered by the agenace as a guide to corrective action and should be responsded to promptly and thoroughly, generally within ''10 working days''

<html>
<iframe src="http://docs.google.com/viewer?url=http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127434.pdf&embedded=true" width="600" height="780" style="border: none;"></iframe></html>

!FDA 483 Response letter
Tips:
* Your response letter should request that a copy of your response be included with any request for your forms 483.
User-agent: *
Disallow: /bags
Disallow: /recipes
<<forEachTiddler
 where
 'tiddler.tags.contains("Audio")'
 sortBy 
        'tiddler.title.toUpperCase()'
 script
 '
 function getFirstLine(s) {
 var m = s.match(/\s*(.*)/);
 return m != null && m.length >= 1 ? m[1] : "";
 }
 '
 write
 '"[["+tiddler.title+"]]\n"' 

>>
/***
|Name|BookmarkletPlugin|
|Version|0.1|
|Author|Ben Gillies|
|Type|plugin|
|Description|Generate a bookmarklet that will pop up your TiddlyWiki inside a different web page|
!Usage
To generate the bookmarklet, use:

<<bookmarklet tiddler>>

where tiddler is the (optional) name of the tiddler you want to view.

It will generate a bookmarklet for you that will pop up whichever tiddler you specify from within whichever bag/recipe you call it from from any website.

It will load everything up using the BookmarkletTheme tiddler which has been designed to work in a small space (the side of your screen).

This plugin comprises 4 tiddlers. All of which should be accessible from the recipe/bag you load the bookmarklet in:
*bookmarklet.css (the CSS for the side bar that loads up when you click the bookmarklet)
*bookmarklet.js
*BookmarkletPlugin (this tiddler)
*BookmarkletTheme

Requires TiddlyWeb
!Code
***/
//{{{
if(!version.extensions.BookmarkletPlugin)
{ //# ensure that the plugin is only installed once
    version.extensions.BookmarkletPlugin = { installed: true }
};

config.macros.bookmarklet = {
    root: {},
	bookmarkletTemplate: '!URL\n{URL}\n\n!Description\n{Description}',
    handler: function(place, macroName, params, wikifier, paramString, tiddler){
        if (!config.defaultCustomFields)
            throw 'defaultCustomFields Not Found. This plugin requires TiddlyWeb to work.';
        var urlBase = config.defaultCustomFields['server.host'];
        urlBase += urlBase[urlBase.length - 1] !== '/' ? '/' : '';
        var path = escape(config.defaultCustomFields['server.workspace']);
        var siteTitle = document.title;
        var escapedSiteTitle = ',%22' + escape(siteTitle) + '%22';

        var tiddler = params.length > 0 ? ',%22' + escape(params[0]) + '%22' : ',null';

        var bookmarklet = 'javascript:(function(){'
            + 'var%20u=%22' + urlBase + '%22;var%20p=%22' + path + '%22;'
            + 'var%20s=document.createElement(%22script%22);'
            + 's.type=%22text/javascript%22;'
            + 's.src=u+p+%22/tiddlers/bookmarklet.js%22;'
            + 'document.body.appendChild(s);'
            + 'var%20lT=setInterval(function(){'
            + 'if(window.openTiddlyWiki){'
            + 'window.openTiddlyWiki(u,p' + tiddler + escapedSiteTitle + ');'
            + 'clearTimeout(lT);'
            + '}},100);})();';

        var link = jQuery('<a/>')
            .attr('href', bookmarklet)
            .text(siteTitle)
            .appendTo(place);
    },
    receiveMessageHandler: function(message) {
        var rootData = config.macros.bookmarklet.root;

        if (/^title:/.test(message.data)) {
            rootData.title = message.data.substr(6);
        } else if (/^desc:/.test(message.data)) {
            rootData.desc = message.data.substr(5);
        } else if (/^url:/.test(message.data)) {
            rootData.url = message.data.substr(4);
        }

        if ((rootData['desc']) && (rootData['title']) && (rootData['url'])) {
            //try and find the tiddler
            //If we got here via query string (aka - a lack of window.postMessage), the page won't have finished loading properly yet.
            //so we have to wait for a bit until we can call story.displayTiddler properly.
            if (!window.postMessage) {
                oldRestart = window.restart;
                window.restart = function() {
                    config.macros.bookmarklet.findTiddler(rootData);
                    oldRestart();
                    window.restart = oldRestart;
                };
            } else {
                config.macros.bookmarklet.findTiddler(rootData);
            }
        }
    },
    findTiddler: function(data) {
        var tiddler = store.getTiddler(data['title']);
        if (tiddler) {
            story.displayTiddler(document.body, tiddler.title, 2);
            return;
        }

        var tiddlers = store.search(data['url'], null, 'excludeSearch');
        if (tiddlers.length > 0) {
            story.search(data['url']);
            return;
        }
        //we haven't found it. So create a new one.
        tiddler = new Tiddler(data['title']);
        tiddler.tags = ['bookmark'];
        tiddler.text = config.macros.bookmarklet.bookmarkletTemplate
            .replace('{URL}', data['url'])
            .replace('{Description}', data['desc']);
        tiddler.fields = merge({}, config.defaultCustomFields);
        store.addTiddler(tiddler);
        story.displayTiddler(document.body, tiddler.title, 2);
    }
};

;

/********************************************/
/****Bookmarklet Theme and switching code****/
/********************************************/
(function() {
    if (window.self !== window.top) {
        config.options.txtTheme = 'BookmarkletTheme';
        var receiveMessage = config.macros.bookmarklet.receiveMessageHandler;
        if (!window.postMessage) {
            //the message will be coming through the query string #ie6 probably
            var queryObj = {};
            var data = (window.location.search.substr(0, 1) === '?') ? window.location.search.substr(1) : window.location.search;
            data = data.split('&');
            for (var i=0; i<data.length; i++) {
                var keyValPair = data[i].split('=');
                queryObj[keyValPair[0]] = decodeURIComponent(keyValPair[1]);
            }
            if (queryObj['bookmarkletParentURL']) {
                var message = {};
                message.data = 'url:' + queryObj['bookmarkletParentURL'];
                receiveMessage(message);
                if (queryObj['bookmarkletParentTitle']) {
                    message.data = 'title:' + queryObj['bookmarkletParentTitle'];
                    receiveMessage(message);
                }
                if (queryObj['bookmarkletParentDesc']) {
                    message.data = 'desc:' + queryObj['bookmarkletParentDesc'];
                    receiveMessage(message);
                }
            }
        } else {
            if (typeof window.addEventListener != 'undefined') {
                window.addEventListener('message', receiveMessage, false);
            } else if (type.attachEvent != 'undefined') {
                window.attachEvent('onmessage', receiveMessage);
            }
        }
    } else if (config.options.txtTheme == 'BookmarkletTheme') {
        config.options.txtTheme = '';
    }
})();
//}}}
''Software Validation'' is a part of the [[Design Validation]] for a finished device, but is not separately defined in the Quality System regulation. For purposes of this guidance, FDA considers software validation to be:
''//confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled//''
In practice, software validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled. Since software is usually part of a larger hardware system, the validation of software typically includes:
//''evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements''//

A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle. Testing of device software functionality in a simulated use environment, and user site testing are typically included as components of an overall design validation program for a software automated device
In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Human Factors//'' are those design activiies that addres the human interface, for example, the device and the user performance, and the user's training in the operation, maintenance and installation of a medical device.
//(2) Measuring compliance//
The [[AKR]] shall be measured in accordance with paragraph (d) of this section. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of 100 square cm with no linear dimension greater than 20 cm. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 cm. Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.
<svg xmlns="http://www.w3.org/2000/svg" xmlns:xl="http://www.w3.org/1999/xlink" version="1.1" viewBox="364 157 64 51" width="30" height="30"><g stroke="none" stroke-opacity="1" stroke-dasharray="none" fill="none" fill-opacity="1"><g><path class="glyph" d="M 364.50006 184.50061 L 386.99985 207.00037 L 396 198.00002 L 373.50003 175.50066 Z M 403.02295 181.97704 C 400.38693 179.34099 396.11307 179.34099 393.47702 181.97704 C 390.841 184.61307 390.841 188.88695 393.47702 191.52298 C 396.11307 194.15903 400.38693 194.15903 403.02295 191.52298 C 405.65906 188.88695 405.65906 184.61307 403.02295 181.97704 M 414.27298 170.72704 C 411.63693 168.091 407.36307 168.091 404.72702 170.72704 C 402.091 173.36308 402.091 177.63693 404.72702 180.27296 C 407.36307 182.90901 411.63693 182.90901 414.27298 180.27296 C 416.90903 177.63693 416.90903 173.36308 414.27298 170.72704 M 425.523 159.47705 C 422.88696 156.841 418.6131 156.841 415.97705 159.47705 C 413.341 162.11308 413.341 166.38695 415.97705 169.02295 C 418.6131 171.65903 422.88696 171.65903 425.523 169.02295 C 428.15906 166.38695 428.15906 162.11308 425.523 159.47705" fill="#020202"/></g></g></svg>
In the FDA's Quality System Requirements ''Quality Policy'' means the overall quality intentions and direction of an organization with respect to [[Quality]] by [[Management with executive responsibility]]
In the FDA's Quality System Requirements ''Establish'' means define, document (in writing or electronically), and implement