Blog Archive: MDSAP

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MDSAP: The Ultimate Guide to the Medical Device Single Audit Program

The MDSAP was designed to allow a single audit of a medical device manufacturer to be applied to all country markets whose regulatory authorities are members of the program. A report from a single MDSAP audit is an accepted substitute for routine inspections by all the member Regulatory Authorities across the world.

MDSAP Device Marketing Authorization and Facility Registration

What is the Medical Device Single Audit Program (MDSAP)? The International Medical Device Regulators Forum (IMDRF) recognized that a global approach to auditing and monitoring the manufacturing of medical devices could improve their

Podcast – Streamlining the MDSAP Device Marketing Authorization and Facility Registration Process

I had the opportunity to sit down with Jon Speer, Founder & VP of QA/RA at Greenlight Guru to record a podcast to discuss streamlining the MDSAP Marketing Authorization & Facility Registration Process. If you are not familiar with…