FDA Medical Device Regulatory Compliance Audit Program – MDSAP

The Medical Device Single Audit Program (MDSAP) offers a harmonized approach to evaluating the quality systems of medical device manufacturers across five markets: US, Canada, Australia, Brazil, and Japan. Developed by the International Medical Device Regulators Forum (IMDRF), the Medical Device Single Audit Program allows medical device manufacturers to be audited only once for compliance with the standard and regulatory requirements of ISO 13485 and the country-specific applicable regulations, which include those imposed by the TGA of Australia, Brazil’s ANVISA, Health Canada, Japan’s MHLW, and the FDA.

Our FDA medical device audit experts can help expand your quality system to ensure regulatory authority scrutiny. When you partner with us to achieve MDSAP regulatory compliance, you will benefit from:

  • Fewer FDA medical device audits and inspections
  • Fewer business disruptions with consolidated audit days
  • An expedited entrance into markets
  • A common audit approach and model


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