Documents

The following page provides resources to support Regulatory Authorities (RAs), Auditing Organizations (AOs) and medical device manufacturers to understand and participate in the MDSAP.

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All documents

Search all documents available on the MDSAP site.

General documents and procedures

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

Assessment procedures and forms

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

Audit procedures and forms

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

IMDRF/MDSAP working group

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.