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]]
bag
fda_public
created
Sun, 01 Jul 2012 14:56:53 GMT
creator
dirkjan
modified
Sun, 01 Jul 2012 14:56:53 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Term
creator
dirkjan