Quality Services
The Medical Device Single Audit Program allows a single third-party audit to satisfy the QMS inspection requirements of FDA, Health Canada, TGA, PMDA, and ANVISA. For companies selling in multiple regulated markets, MDSAP reduces audit burden — but only if your QMS is prepared for the task-based audit methodology MDSAP uses.
Prepare for MDSAPMDSAP Program
The Medical Device Single Audit Program (MDSAP) is a cooperative program among five regulatory authorities: the US FDA, Health Canada, the Australian Therapeutic Goods Administration (TGA), Japan's PMDA, and Brazil's ANVISA. An MDSAP certificate issued by an accredited auditing organization satisfies the QMS inspection requirements of all five jurisdictions, eliminating the need for separate regulatory audits in each country. Health Canada requires MDSAP for medical device licenses in Canada, making MDSAP mandatory for Canadian market access. FDA accepts MDSAP audit reports in lieu of routine surveillance inspections but does not require MDSAP participation for US manufacturers.
MDSAP audits are conducted against the ISO 13485:2016 standard with country-specific regulatory requirements layered on top. Each of the five participating regulatory authorities has added country-specific requirements to the MDSAP audit sequence, so the MDSAP audit is broader in scope than an ISO 13485 certification audit alone. Companies considering MDSAP should evaluate whether their QMS satisfies not just ISO 13485 but also the country-specific requirements for each jurisdiction in which they seek recognition.
MDSAP uses a task-based audit model rather than a clause-based model. The audit is structured around seven process areas — Management, Device Marketing Authorization and Facility Registration, Design and Development, Production and Service Controls, Measurement, Analysis and Improvement, Purchasing and Supplier Controls, and Vigilance and Post-Market Surveillance — each of which contains numbered tasks that auditors evaluate in a specific sequence. The task sequence is fixed, and country-specific requirements are incorporated at specific task points.
The MDSAP grading scale determines the severity of audit findings. Grading 1 through 5 reflects increasing severity — Grade 5 requires immediate notification to regulators. Understanding the grading criteria and how auditors apply them is essential for MDSAP preparation. A finding that would be a minor nonconformity under ISO 13485 could be graded differently under MDSAP depending on the country-specific requirements that apply at that task point.
MDSAP readiness assessment evaluates your QMS against the MDSAP audit model — not just ISO 13485 requirements. For each of the seven process areas, we assess whether the QMS documentation, records, and implemented processes satisfy the specific MDSAP task requirements and the country-specific regulatory requirements that overlay each task. The assessment identifies gaps that would generate audit findings and prioritizes them by the MDSAP grading criteria most likely to apply. A mock MDSAP audit simulates the actual task-based audit sequence, providing experience with the methodology before the actual auditing organization arrives.
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MDSAP reduces audit burden for multi-market device companies — but only when your QMS is prepared for the task-based methodology. We get you ready for the audit that counts across all five jurisdictions.