In FDA [[Design Controls|CFR 21-820.30 - Design Controls]] ''//Failure Mode, Effect and Criticality Analysis//'' (FMECA) is [[FMEA|Failure Mode and Effect Analysis]] process that includes an assesment of the criticality of identified fault modes.
bag
fda_public
created
Sun, 01 Jul 2012 15:08:03 GMT
creator
dirkjan
modified
Sun, 01 Jul 2012 15:08:03 GMT
modifier
dirkjan
tags
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Term
creator
dirkjan