Documents

Search all documents available on the MDSAP site.

These documents provide information on the creation and operation of the MDSAP.

These documents support the AO Assessment and Recognition Decision related processes.

These documents support the MDSAP approach for a third-party audit of a medical device manufacturer.

As part of the creation of MDSAP, the IMDRF MDSAP Working Group developed a standard set of requirements for third-party AOs performing regulatory audits of medical device manufacturers’ QMS.

The following QMS documents provide a transparent overview on how MDSAP RAs are working together to ensure a quality program.

Notices and Transmittals from MDSAP.

Summary Outcome Statements from MDSAP annual forums.