Dirkjan: Created page with "Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the..."

2020-08-25T07:18:42Z

Created page with "Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the..."

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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|Design History File]] (DHF).
=Attention points=
Design verification and validation are two different activities:
* Design verifications intent is to ensure that the [[CFR 21-820.30d - Design Output|Design Outputs]] meet the [[CFR 21-820.30c - Design Input|Design Inputs]]. 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:

<html><img src = "/static/files/FDA/82030a.jpg" width="400"/></html>

=Design verification and validation activities=
{{:Design verification and validation activities}}

[[Software Verification|Software Verification]] is a special topic in the context of design verification.
[[Category:fda]]

[[Category:CFR]]

[[Category:CFR 21-820.30]]

[[Category:Design Controls]]

[[Category:FDA]]

[[Category:Quality System Requirements]]

[[Category:Section]]

CFR 21-820.30f - Design Verification - Revision history

Dirkjan: Created page with "Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the..."