Medical Device Single Audit Program (MDSAP) Overview

The Medical Device Single Audit Program (MDSAP) offers medical device manufacturers a more efficient approach to meeting regulatory requirements across multiple international markets. This course introduces you to the MDSAP framework, including its purpose, participating regulatory authorities, audit process, and relationship to ISO 13485. You’ll gain a better understanding of how a single regulatory audit can help manufacturers demonstrate compliance with the requirements of multiple participating countries.

Whether you’re a quality assurance professional, regulatory affairs specialist, auditor, or medical device manufacturer, understanding MDSAP can help you navigate international regulatory expectations with greater confidence. This course provides a practical foundation for understanding how MDSAP audits work, what auditors evaluate, and how the program supports regulatory compliance and effective quality management systems.