In the ever-evolving landscape of medical device manufacturing and distribution, ensuring product quality and regulatory compliance is paramount. The Medical Device Single Audit Program (MDSAP) has emerged as a comprehensive approach to streamline regulatory processes for medical device companies across different countries. At the heart of MDSAP lies a crucial tool - the MDSAP Audit Guide.
The MDSAP is a program developed by the International Medical Device Regulators Forum (IMDRF), aiming to create a harmonized approach to auditing and monitoring the manufacturing of medical devices. This collaborative effort involves regulatory authorities from multiple countries, including the United States, Canada, Australia, Brazil, and Japan. The MDSAP Audit Guide serves as a key resource for organizations navigating the complex regulatory landscape.