An introduction to the Medical Device Single Audit Program

By Mehryar Behizad2025-02-07T12:33:00

The Medical Device Single Audit Program (MDSAP) is an International Medical Device Regulatory Forum (IMDRF) scheme whereby the regulatory authorities of member jurisdictions have agreed to subcontract regulatory surveillance of the industry to existing notified bodies (NBs).

This article aims to summarise the features of MDSAP and its increasing importance as a mechanism by which regulatory authorities monitor medical device (MD) industry participants.

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