The MDSAP or Medical Device Single Audit Program is a program for companies that sell product in multiple countries. MDSAP is especially designed for organizations operating with multiple sites and in multiple markets. MDSAP is a way that medical device manufacturers can be audited once a year for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

A full MDSAP Audit comprises seven process chapters, including:

  • Chapter 1 Process: Management
  • Chapter 2 Process: Device Marketing Authorization and Facility Registration
  • Chapter 3 Process: Measurement, Analysis and Improvement
  • Chapter 4 Process: Medical Device Adverse Events and Advisory Notices Reporting
  • Chapter 5 Process: Design and Development
  • Chapter 6 Process: Production and Service Controls
  • Chapter 7 Process: Purchasing

What are the 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.

At SMG we are ready to ensure your system is compliant with MDSAP by conducting a Gap Assessment and come up with the proper action to close any gaps.

Our Gap Assessment Audit criteria of the MDSAP program includes the requirements of ISO 13485 and the applicable requirements of the participating regulatory authorities. In addition, other requirements will be included in the program such as specific requirements of each regulatory authority for product(s) and company registration(s), licensing requirements and any particular requirements related to the reporting of adverse events.


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