Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

Audits are conducted by Auditing Organizations (AO), such as BSI, which are authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.