MDSAP Audit (Medical Device Single Audit Program)

MDSAP stands for “Medical Device Single Audit Program” where the specific national requirements of members of the scheme and the requirements of ISO 13485 are all covered by one single audit.

Those working in legal and international trade departments in the medical device sector and also in quality management, including internal and external QM auditors, have to follow the MDSAP Audit Approach and should have excellent knowledge of the requirements of the program.

All the audit requirements of MDSAP are documented in the MDSAP Audit Approach. This document is available on the FDA website.

The different tasks are described in the 7 process chapters of the MDSAP:

Process Chapter 1: Management

Process Chapter 2: Device Marketing Authorization and Facility Registration

Process Chapter 3: Measurement Analysis and Improvement

Process Chapter 4: Medical Device Events and Advisory Notices Reporting

Process Chapter 5: Process: Design and Development

Process Chapter 6: Production Service and Controls

Process Chapter 7: Purchasing

The MDSAP Audit Approach describes the individual requirements of the program and it also contains explanations, links between the individual tasks and applicable regulatory requirements. This gives a good overview of the expectations which apply during the MDSAP audit.

An MDSAP audit can be combined with an (existing) CE certification or certification to ISO 13485.

The International Medical Device Regulators Forum (IMDRF) was founded in February 2011 to discuss the future direction of regulatory harmonization in the field of medical technology. The forum is made up of voluntary groups of medical regulators from around the world and aims to accelerate the harmonization and convergence of regulations in the international medical industry.