How to Prepare for Medical Device Single Audit Program (MDSAP) 

Global medical device manufacturers must undergo audits of their quality management systems by regulators in the countries in which they sell their products. This could mean multiple audits by numerous agencies each with their own scientific principles, requirements and processes.

Medical Device Single Audit Program (MDSAP) was introduced by the International Medical Device Regulators Forum (IMDRF) to develop a single audit of a quality management system that satisfies medical device regulatory authorities. The impact is recognized Auditing Organizations (AOs) conduct a single audit of a medical device manufacturer that will meet the requirements of multiple regulatory agencies. The pilot phase of the program is over so make sure your system is ready to gather the required data in 2017.

During this webcast, you will learn:
  • What is MDSAP?
  • What are the driving factors and impact on the Medical Device Industry?
  • Why prepare now?

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Tom Middleton

Solutions Architect

Sparta Systems

Before joining Sparta, Tom spent twenty years conducting nearly 1,000 registration, surveillance, internal and supplier audits as an ASQ / RAB Certified ISO and Global cGMP lead compliance auditor for Underwriter’s Laboratories and Bausch + Lomb’s Surgical Division. 

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