Pathway to MDSAP Whitepaper

The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to satisfy the needs of multiple regulatory jurisdictions, which currently include the U.S., Canada, Brazil, Australia and Japan. The single audit of a medical device manufacturer’s QMS will include the assessment of processes including management responsibility, resource management, product realization, measurement, analysis and improvement, and adverse event reporting; as well as compliance with Good Manufacturing Practices (GMPs) or other applicable requirements as outlined in the MDSAP audit approach.

This white paper assumes you are aware of the MDSAP’s history and background and outlines the broad steps for medical device manufacturers to consider in their transition to MDSAP certification and their interactions with recognized Auditing Organizations (AOs).