Each manufacturer shall establish and maintain procedures for verifying the device design. Design [[verification|Verification]] shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the [[Design History File]] (DHF).
!Attention points
Design verification and validation are two different activities:
* Design verifications intent is to ensure that the [[Design Outputs|CFR 21-820.30d - Design Output]] meet the [[Design Inputs|CFR 21-820.30c - Design Input]]. Design verification can be described as the activities with determining if the device was made 'right'.
* Design validation refers to activities that determine whether the device was made correctly and whether the device meets its intended uses.

See also the picture below to see the difference:
<<image /static/files/FDA/82030a.jpg width:400>>

!Design verification and validation activities
<<tiddler [[Design verification and validation activities]]>>

[[Software Verification]] is a special topic in the context of design verification.
bag
fda_public
created
Sat, 08 Sep 2012 14:16:16 GMT
creator
dirkjan
modified
Sat, 08 Sep 2012 14:16:16 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan