Medical Device Single Audit Program (MDSAP) Training

Currently there are no upcoming Medical Device Single Audit Program (MDSAP) Training courses scheduled. Contact us to find out when the next course will run or if you need customized training. We can deliver this course and a broad range of other training topics at your location, off-site or virtually.

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About This Course

Students will learn 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. We will discuss the audit approach used by recognized MDSAP auditing organizations (AOs) in depth. Students will also learn the MDSAP nonconformity grading system and identify what MDSAP audit findings may trigger action from a participating regulatory authority.

Key Learning Objectives

By the end of this NSF MDSAP training course, you 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 International Medical Device Regulators Forum (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.

Course Tutors

Robert Ruff - Robert Ruff has over 30 years of experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed the FDA's computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.