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.
bag
fda_public
created
Sun, 01 Jul 2012 15:00:18 GMT
creator
dirkjan
modified
Sun, 01 Jul 2012 15:00:18 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Term
creator
dirkjan