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.
bag
fda_public
created
Sun, 01 Jul 2012 20:15:55 GMT
creator
dirkjan
modified
Sun, 01 Jul 2012 20:15:55 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Term
creator
dirkjan