Maps to
QMSR / ISO 13485: §820.30(e)
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.
What changed
Part 820.30(e) required formal documented reviews of design results at appropriate stages. Each review had to include an independent reviewer — someone who does not have direct responsibility for the design stage being reviewed. Results of the review, including identification of problems and actions taken, had to be documented.
ISO 13485:2016 clause 7.3.5 requires systematic reviews at suitable stages to evaluate the ability of results to meet requirements, identify any problems, and propose necessary actions. Participants must include representatives of functions concerned with the design stage being reviewed, as well as other specialist personnel. However, ISO 13485 does not explicitly require an 'independent reviewer' — this is a significant structural difference.
The FDA addressed this gap directly in the QMSR preamble (Comment 46 response). The agency concluded that while ISO 13485's requirement for 'specialist personnel' could encompass independent review, the FDA continues to expect that design reviews include an independent reviewer as a best practice. The FDA stated that independent review adds 'an important contribution, such as a fresh perspective to matters and can challenge general assumptions made by the design and development team.' This means that while the literal text of ISO 13485 7.3.5 does not mandate independent reviewers, FDA inspectors will still look for this practice during inspections.
ISO 13485 also adds specificity around the purpose of reviews: evaluating the ability of design results to meet requirements and identifying problems. Part 820 was less prescriptive about review objectives. The documentation requirement is similar — both mandate recording results and any necessary actions — but ISO 13485 is more explicit about recording follow-up actions and their status.
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.
- •Reviews must be systematic, not informal, and must explicitly evaluate whether design results are capable of meeting requirements.
- •Review records must document identified problems and proposed necessary actions, with assigned responsible parties and target completion dates.
- •Design reviews must be conducted at the stages specified in the design and development plan, not ad hoc.
- •Follow-up on action items from prior reviews must be confirmed before or at the subsequent review.
Common gaps
No independent reviewer despite FDA expectation
majorWhile ISO 13485 7.3.5 does not explicitly require an independent reviewer, the FDA's QMSR preamble makes clear that independent review remains an expectation. Companies that relied on Part 820's explicit language and have now shifted to ISO 13485's text alone may drop the independent reviewer requirement from their procedures, creating an inspection risk.
Lack of independent reviewer
majorDesign reviews are attended only by the core project team, missing the 'independent' reviewer required by the QMSR (retained from 820.30(e)).
Design review records lack problem identification and proposed actions
moderateISO 13485 7.3.5 requires that review records include identification of problems and proposed actions. Many legacy design review meeting minutes capture attendees, agenda, and decisions but do not systematically document identified problems, proposed actions, responsible parties, and follow-up status.
Reviews not conducted at stages defined in the design plan
moderateISO 13485 7.3.5 requires reviews 'at suitable stages, in accordance with planned and documented arrangements.' Some companies conduct ad hoc design reviews rather than reviews formally linked to the stages defined in their design and development plan per 7.3.2.
Missing cross-functional representation at reviews
moderateISO 13485 7.3.5 requires participants to include 'representatives of functions concerned with the design and development stage(s) being reviewed.' Some companies conduct design reviews with only engineering participants, without representation from quality, regulatory, manufacturing, or clinical functions.
Evidence signals
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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.