Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

White paper - MDSAP certification

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As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device manufacturers. More manufacturers are expected to participate in MDSAP in 2018, particularly as Health Canada’s compliance deadline of January 2019 approaches.

This white paper assumes you are aware of the MDSAP’s history and background, and outlines the broad steps for medical device manufacturers to consider in their transition to MDSAP certification and their interactions with recognized Auditing Organizations (AOs). You will learn:

  • Steps in the MDSAP transition process
  • MDSAP gap analysis and training requirements
  • How to select an Auditing Organization
  • Internal audit and management review processes
  • What to expect from an MDSAP certification audit
  • and much more.

Download our 8-page white paper to learn more about transitioning to the MDSAP.