MDSAP · Medium · 15 min lesson
Chapter 5 Design and development - seventeen tasks: planning, inputs, V&V, software, clinical evaluation, change and transfer
MDSAP Audit Approach Chapter 5 (17 tasks); ISO 13485:2016 clauses 7.3.1 to 7.3.10, 4.1.6 and 1.2; ISO 14971 and IEC 62304 links
What you will learn
- Audit the 17 design and development tasks of Chapter 5.
- Judge a claimed design exclusion.
- Link design records to risk management and to complaints.
Key takeaways
- Chapter 5 has 17 tasks, audited by selecting a completed project using risk, software content, change and Chapter 3 data.
- A design exclusion is acceptable only where regulation permits, with justification in the quality manual and checks in every market.
- Trace input to output to verification to validation, and trace each hazard to a control and proof the control works.
- Software and firmware changes are design changes under clause 7.3.9: approval before release, risk file update and market notification decision.
- Clause 7.3 findings start at base grade 3 and clause 4.1.6 at base grade 1; add one per escalation rule, capped at 5.
Free practice question
Fennick's design file shows a risk control, a torque limiter, listed in the risk file. There is no test report showing that the limiter works as claimed.
Which MDSAP Chapter 5 task is most directly concerned?
Task 9: verification or validation of the effectiveness of risk control measures
Correct. MDSAP Chapter 5 task 9 expects evidence that a risk control is effective, supporting clauses 7.3.6 and 7.3.7.
Task 1: identification of devices
Not quite. MDSAP task 1 only identifies devices and documentation; it does not test the proof for a risk control.
Task 15: impact on devices already distributed
Not quite. MDSAP task 15 concerns changes affecting delivered devices, which is not the gap in this risk control record.
Task 17: top management commitment
Not quite. Task 17 is judged at the end and does not examine a specific verification record in MDSAP Chapter 5.
Key terms
- design input: A requirement for function, performance, safety, regulation or risk control that the design must meet (clause 7.3.3).
- design verification: Confirmation, with objective evidence, that design outputs meet design inputs (clause 7.3.6).
- design validation: Confirmation that the device meets the needs of its intended use, on representative product (clause 7.3.7).
- design exclusion: Omitting design and development from the quality system where regulation permits (clauses 1.2 and 4.2.2).
- design transfer: Verifying that design outputs are suitable for manufacture before they become production specifications (clause 7.3.8).
Official sources
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- Medical Device Single Audit Program (MDSAP) Frequently Asked Questions (FDA)
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14971:2019 Medical devices - Application of risk management to medical devices
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.