ISO 13485 · Medium · 14 min lesson
Design review, verification, validation, transfer and change - clauses 7.3.5 to 7.3.10 and the DHF
ISO 13485:2016 clauses 7.3.5 to 7.3.10, with the design and development file and regulatory context
What you will learn
- Run and record design reviews under clause 7.3.5 and plan verification under clause 7.3.6 so evidence is tied to the product.
- Plan design validation on representative product under clause 7.3.7 and explain the role of clinical or performance evaluation.
- Control design transfer, design changes and the design and development file under clauses 7.3.8 to 7.3.10.
Key takeaways
- Clause 7.3.5: systematic reviews with the functions concerned, and records of design, participants, date, results and actions.
- Clause 7.3.6: verification is planned with methods, acceptance criteria and sample rationale, and identifies the configuration tested.
- Clause 7.3.7: validation uses representative product with a recorded rationale, includes clinical or performance evaluation as required, and precedes release.
- Clause 7.3.8: show outputs are suitable for manufacture and production capability meets requirements.
- Clauses 7.3.9 and 7.3.10: assess and approve changes before implementation, and keep a design file with changes recorded.
Free practice question
Norvane holds its Halo critical design review. Only the project engineer who drew the design attends, and the record reads: reviewed, all OK. There is no date and no list of findings.
What does clause 7.3.5 require that is missing?
Participants from the functions concerned, and a record of results, date and actions.
Correct. Clause 7.3.5 requires functions concerned to participate and records of results and necessary actions.
A second copy of the drawings.
Not quite. Extra copies are not what clause 7.3.5 asks for; it requires review participants and records.
A press release.
Not quite. Press releases play no role in the design review requirements of clause 7.3.5.
Approval by the sales team alone.
Not quite. Sales alone is not the group of functions concerned with the stage under clause 7.3.5.
Key terms
- design review: A systematic examination at a planned stage of whether the design can meet requirements, with participants from concerned functions (clause 7.3.5).
- design verification: Confirmation that design outputs meet design inputs, done under planned arrangements (clause 7.3.6).
- design validation: Confirmation that the resulting product can meet the requirements for its specified application or intended use (clause 7.3.7).
- representative product: Initial production units, batches or their equivalents used for design validation (clause 7.3.7).
- design transfer: Handover of verified outputs to manufacturing with evidence of production capability (clause 7.3.8).
- design change: A modification to design outputs, assessed and approved before implementation (clause 7.3.9).
- design and development file: The file per device type or family holding records of conformity and design changes (clause 7.3.10); often called DHF in the US.
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- FDA, Design Control Guidance for Medical Device Manufacturers
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.