ISO 13485 · Medium · 13 min lesson
Design and development planning, inputs and outputs - clauses 7.3.2 to 7.3.4
ISO 13485:2016 clauses 7.3.1 to 7.3.4, with EU MDR Article 10(9) and Annexes I and II and the US QMSR as context
What you will learn
- Explain what a design and development plan must contain under clause 7.3.2 and recognise a plan that is too thin.
- Write design inputs that are complete, unambiguous, testable and conflict free, and review and approve them under clause 7.3.3.
- Define design outputs that meet clause 7.3.4 and show their traceability back to inputs, including risk controls.
Key takeaways
- Clause 7.3.2: a living plan with stages, reviews, verification, validation and transfer, owners, traceability method and competence.
- Clause 7.3.3: inputs are complete, unambiguous, verifiable, conflict free, reviewed for adequacy and approved.
- Risk management outputs and applicable regulatory requirements and standards are design inputs.
- Clause 7.3.4: outputs meet inputs, support purchasing, production and service, carry acceptance criteria and specify safety-essential characteristics.
- A traceability matrix from input to output to test makes design control visible to an auditor.
Free practice question
Norvane starts the Halo project with a one-page schedule. Reviews will happen when engineering feels ready, and nobody has written down who may approve a drawing. Two engineers later disagree about who owns the battery design.
What does clause 7.3.2 require here?
Plan stages, reviews, responsibilities and authorities, and keep the plan current.
Correct. Clause 7.3.2 lists stages, reviews, responsibilities and authorities as the minimum content of a design plan.
Nothing until a notified body asks for it.
Not quite. Clause 7.3.2 applies to every project from the start and is not triggered by an external request.
Only a launch date and a budget.
Not quite. Dates and budgets are management information, but clause 7.3.2 asks for control content such as reviews and authorities.
A plan written after the design is finished.
Not quite. Clause 7.3.2 requires planning and control during design, and the plan is updated as the design progresses.
Key terms
- design input: A requirement the design must meet: functional, performance, usability, safety, regulatory and risk control requirements (clause 7.3.3).
- design output: The result of design: drawings, specifications, software and acceptance criteria that meet the inputs (clause 7.3.4).
- design plan: The documented plan of stages, reviews, responsibilities, traceability and resources for one project (clause 7.3.2).
- traceability: The documented link from each output to the input it satisfies and onward to verification (clause 7.3.2 e).
- acceptance criteria: The values or conditions that show a product or output is acceptable, contained in or referenced by outputs (clause 7.3.4 c).
- risk control: A measure that reduces risk; once chosen it becomes a design input and is implemented and verified.
- intended use: The purpose for which the manufacturer designs the device; inputs are set according to it (clause 7.3.3 a).
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.