Navigating the MDSAP

Navigating the FDA’s Medical Device Single Audit Program (MDSAP) may cover all regulatory requirements. However, it does not mean that a product will be cleared or approved, but it’s an extra step that could lead to only one audit being performed.
In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Danny Kroo, a medical device consultant and sub-contract lead auditor for several registrars that provides quality management system (QMS) and regulatory affairs services.