Maps to
FDA QMSR (Part 820): §820.30(e)
ISO 13485: ISO 13485 §7.3.5
Requirement text
At suitable stages, systematic reviews of design and development shall be performed to evaluate the ability of results to meet requirements, identify problems, and propose necessary actions. Participants shall include representatives of functions concerned with the design stage being reviewed, as well as other specialist personnel. FDA-Plus: Reviews must include independent reviewers not directly responsible for the design stage under review.
Atomic constraints
- •Reviews must be conducted at suitable stages per the design plan.
- •Reviews must evaluate ability of design outputs to meet input requirements.
- •Review participants must include representatives of all concerned functions.
- •At least one reviewer must be independent of the design stage under review.
- •Results of reviews and subsequent actions must be recorded.
Evidence signals
- •
FILE_EXISTS
(Design.*Review|Review.*Minutes|Phase.*Gate)
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CONTENT_MATCH
Does this document record design review participants, decisions, and action items with an independent reviewer?
Audit defense
Design reviews for [your product] are documented in [your document ID]. Each review includes cross-functional attendees and at least one independent reviewer per QMSR requirements, with action items tracked to closure.