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.
bag
fda_public
created
Sun, 22 Jul 2012 12:18:09 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 12:18:09 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan