Medical Device Single Audit Program (MDSAP)
What you'll gain from this course
This instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.
This course discusses, in depth, the audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system. Learners will also identify what MDSAP audit findings may trigger action from a participating regulatory authority.
Tutor
This training will be delivered by one of our experts – click here to learn more .
Learning Outcomes
By the end of this training, learners will be able to:
- Discuss the Medical Device Single Audit Program (MDSAP)
- Evaluate the MDSAP Quality Management System (QMS) audit nonconformity grading system and recognize grades that may trigger regulatory follow-up
- Identify the IMDRF MDSAP requirements and documents in use
- Explain the MDSAP Audit Approach
Who Should Attend
This instructor-led MDSAP training course is vital for any medical device quality professional — including quality directors, managers, engineers, and auditors — who is responsible for implementing a quality management system in accordance with ISO 13485:2016 and who plans to undergo an MDSAP audit.
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