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Audits FAQs

Responses to commonly asked questions related to MDSAP Audits.

Does the audit process include daily review of areas of concern?

Information to be provided medical device manufacturers during the audit process.

How does the MDSAP ensure effort is not duplicated for manufacturers that sell in multiple jurisdictions?

Information on the MDSAP’s Audit Approach process.

How does the MDSAP ensure medical devices are manufactured in accordance with multiple jurisdictional regulations?

Information on the MDSAP’s coverage of medical device regulations.

Does the MDSAP add requirements for the manufacturer?

Information on the MDSAP Audit Approach requirements.

How can a medical device manufacturer participate in the MDSAP?

Information on how to contact an MDSAP AO.