The MDSAP: Easing the Audit Path for Quality Management Systems

Initiated in 2012 by the International Medical Devices Regulators Forum (IMDRF), the Medical Device Single Audit Program (MDSAP) offers medical device manufacturers a mechanism to significantly streamline the process of pre- and post-market audits required by regulatory authorities in jurisdictions around the world. Under the MDSAP, a single audit performed by an authorized auditing organization (AO) is deemed sufficient to assess compliance with the quality management system requirements of regulatory agencies in multiple major medical device markets, including the U.S., Canada, Japan, Brazil and Australia. This single audit approach reduces the need for duplicate quality management audits, helping device manufacturers better manage costs and easing market access.

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