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.
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General documents and procedures

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

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

These documents support the MDSAP approach for a third-party audit of a medical device manufacturer.
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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.
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Quality Management System procedures and forms

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

Notices and Transmittals from MDSAP.
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Outcome Statements

Summary Outcome Statements from MDSAP annual forums.

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