Manufacturers

Manufacturers who are interested in participating in the MDSAP should contact any recognized MDSAP Auditing Organization (AO) directly. Medical device manufacturers do not apply to an MDSAP Regulatory Authority (RA) for an audit under MDSAP.

How medical device manufacturers participate in MDSAP

Manufacturers who are interested in participating in the MDSAP should contact any recognized MDSAP AO directly.

Which manufacturers are eligible to undergo an MDSAP Audit

Information on manufacturers eligible to undergo MDSAP audits.

How to be MDSAP audit ready

An overview on how prepare for an MDSAP audit, including regulatory requirements, audit processes, nonconformity grading, and compliance verification for medical device manufacturers