Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a [[Design Review]], including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the [[DHF]]).
!Attention points
The FDA expects that each deviced designs is formally reviewed. The review should:
* Be performed by appriopriate design teams or individuals with review responsibility
* Occur at appropriate stages
* Include the design team participants that include representatives of all functions concerned with that design stage and at least one //''individual who does not havve a direct responsibility for the design stage being reviewed''// ([[Peer Review]])

The following deliverables should be subject to review:
* Schematics
* Device components
* Subassemblies
* Final [[Risk Analysis]] documents
* Final master [[Verification Plan]]
* Device manufacturing specifications and documentation
* Process validation protocol, if required
* Draft user, maintenance and service documentation
* Initiation of clinical trials if required
* Design and completion of any required integrity testing of the device packaging
* All documentation of verification actvities

Review meeting minutes should be created. Forms and checklists are also useful mechanisms. The may include:
* a [[Design Development Stage Identification Matrix]]
* Review and approval cover sheet
* Review checklists for each review stages
bag
fda_public
created
Mon, 17 Sep 2012 08:01:47 GMT
creator
dirkjan
modified
Mon, 17 Sep 2012 08:01:47 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan