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The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to meet regulatory and quality system requirements in multiple markets through a single audit of their Quality Management System (QMS). Current MDSAP members include Australia, Brazil, Canada, Japan, and the United States, and others are expected to join as the program matures. MSDAP audits are conducted by Auditing Organizations (AO), authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.

MDSAP will be required by Health Canada starting January 1, 2019, which is motivating more manufacturers to adopt the program.

Please refer to the following MDSAP resources from the FDA

ECM has not yet been designated as an Auditing Organization for MDSAP but plans to be in the near future.