MDSAP (Medical Device Single Audit Program)

MDSAP is a program in which a recognized auditing organization performs one audit of a medical device manufacturer's quality system that participating regulators can use.

The audit model follows the MDSAP audit approach, document AU P0002.010. It is organized into seven chapters: management; device marketing authorization and facility registration; measurement, analysis and improvement; adverse events and advisory notices; design and development; production and service controls; and purchasing. The sequence is process-based. It cites ISO 13485 and adds the regulatory tasks each authority requires.

Participating authorities have included the US FDA, Health Canada, Brazil's ANVISA, Australia's TGA and Japan's MHLW/PMDA. Confirm the current participants before you rely on a certificate for a specific submission. An MDSAP certificate is not an ISO 13485 certificate, though the audit covers that standard's requirements inside the model.

HAVGATE ships the seven-chapter task list for internal planning and reporting. See the MDSAP checklist page for how grading and multi-standard sessions work. The software does not certify you.