More Manufacturers Sign Up For Single Audits As MDSAP Becomes Operational

A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.

Inspector removing a white card with Inspector sign from the inner pocket of his jacket. Conceptual of health, business or other inspection coming over unannounced.

Regulatory authorities from around the world participating in the Medical Device Single Audit Program (MDSAP) have seen a “rapid increase” in requests from medtech manufacturers about the program after its pilot phase closed on Dec. 31, 2016.

The number of device manufacturing sites participating in the program rose from 158 at the end of the pilot phase...

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