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MDSAP Overview and Country-Specific Medical Device Regulations: 5-Course Bundle

On-Demand – 12 hours

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Course Overview

This six-course bundle provides an overview of the Medical Device Single Audit Program (MDSAP) and country-specific medical devices regulatory requirements for the United States, Japan, Australia, Brazil and Canada.

Learn what it takes to bring a product to market in each country and keep it there. We cover pre- and post-market requirements, as well as how each country utilizes MDSAP.

NSF’s web-based virtual training course provides the basic knowledge to prepare for MDSAP, helps key personnel realize the urgency of MDSAP readiness and offers answers to vital questions direct from global quality systems expert Kim Trautman, a former U.S. FDA official and key member of the original MDSAP development team. Kim also authored and led the implementation of the current U.S. FDA quality system regulation and is a globally-recognized leader of continuing harmonization efforts for ISO 13485.

Competency assessments provide documented evidence for the training requirements.

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Additional Recommended Courses

Medical Device Single Audit Program (MDSAP)

This virtual instructor-led one-day course (delivered over 2 half days) 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.

This course pairs well as a prerequisite to MDSAP Internal Auditor Training (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should 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


Price: $800.00

Virtual Classroom Training