Medical Devices Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer’s Quality Management System (QMS), which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), such as PPM, which are authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.

MDSAP AUDIT PROCESS

Initial Certification Audit

Surveillance Audit Year 1

Surveillance Audit Year 2

Recertification Audit Year 3

BENEFITS OF MDSAP

  • Minimize medical device manufacturer disruptions due to multiple regulatory audits provide predictable audit schedules (agenda with opening and completion dates)
  • Benefit patient health and patient access with ease of entry to multiple markets leverage regulatory resources
  • Incorporate ISO 13485 assessment requirements, including Australia, Brazil, Canada, Japan and US
  • Reduction in time and resource dealing with findings from multiple audits
  • Reduction in the cost of audits in comparison to independent audits improved transparencies in the industry.

COMMONLY ASKED QUESTIONS

OTHER AUDIT SERVICES OFFERED

Supplier Audits

FDA 21 CFR 820

ISO 13485:2016
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Prime Path Medtech considers it our responsibility to make the audit process as seamless as possible. Learn how we can bring your medical device quality system into compliance.

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