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
bag
fda_public
created
Sun, 22 Jul 2012 11:16:46 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 11:16:46 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan