MDSAP · Basic · 14 min lesson
Preparing for your first MDSAP audit - readiness, country matrix, document pack and mock questions
MDSAP AU P0002 Audit Approach overview and chapters 1 to 7, AU P0008 audit time, AU P0037 grading, IMDRF N3 section 9.5
What you will learn
- Build a country requirements matrix.
- Prepare the document pack and change log.
- Run a readiness review with the Audit Approach.
Key takeaways
- The initial audit has two stages; Stage 2 covers every site to be listed; surveillance is annual and recertification at three years.
- A country requirements matrix with copies of clearance records answers chapter 2 in minutes.
- The document pack and the change log are the first things an auditor asks for.
- Mock questions turn the Audit Approach tasks into practice asked of the people who do the work.
- Run the readiness review in audit sequence, grade by the programme approach, close findings and report at management review.
Free practice question
Marlow plans to supply Japan and Brazil in addition to its existing markets. The RA manager proposes updating the country matrix after the first shipment.
What is the correct timing?
Update the matrix and secure the authorizations before shipping, because chapter 2 tests clearance evidence for each market.
Correct. Chapter 2 of the MDSAP Audit Approach tests evidence of clearance, so authorization must precede shipment.
After the first shipment, since the matrix is only a record.
Not quite. Shipping before clearance breaches the chapter 2 task requirements and the product would be unauthorised in that MDSAP market.
Only at the next yearly review.
Not quite. The matrix should be reviewed whenever a market is entered, not only yearly, in MDSAP preparation.
Never, because the AO maintains the matrix.
Not quite. The manufacturer owns its regulatory evidence under ISO 13485 clause 7.2.1 and MDSAP.
Key terms
- Stage 1 and Stage 2: Stage 1 reviews documentation and readiness; Stage 2 assesses implementation and effectiveness at every listed site (Audit Approach overview).
- surveillance audit: A partial audit between certification and recertification that reviews changes and selected tasks (Audit Approach overview).
- recertification audit: The audit at the end of the three-year cycle that can support a new certificate (AU P0026).
- country requirements matrix: A register of each market, its authorization, regulation, holder, owner and renewal date.
- document pack: An indexed set of records ready for the auditor, organised by audit chapter.
- change log: A dated record of changes to the QMS, devices, validated processes and critical suppliers with evaluation and notification.
- readiness review: An internal audit that follows the Audit Approach sequence before the external audit.
- grade 1 to 5: The nonconformity grading scale applied through GHTF N19; grade 5 or more than two grade 4 blocks certification (IMDRF N3 section 9.5.1).
Official sources
- MDSAP AU P0002.007, MDSAP Audit Approach (FDA)
- IMDRF/MDSAP WG/N3 FINAL:2016 (Edition 2), Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition
- MDSAP AU P0026, Certificate Document Requirements (FDA)
- MDSAP P0003, MDSAP Roles and Responsibilities (FDA)
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.