Medical Device Single Audit Program (MDSAP)

by EMMA International | Apr 10, 2020 | Audits, FDA, MDSAP, Medical Devices

In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program (MDSAP) to implement a harmonized and a global approach to audit medical device manufacturers. The program allows for MDSAP recognized organizations to conduct a single audit that satisfies the regulatory requirements of the countries participating in the program.

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.