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

Resources

Hands compare spinal x-rays

January 15, 2021

Three Takeaways from the Human Factors Engineering & Usability Studies Congress

In early December, I had the good fortune of attending the Human Factors Engineering & Usability Studies Congress online. Although the event could not be held in person, for obvious reasons, it...
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Sterling Medical Devices's Dan Sterling speaking

December 17, 2020

Here in New Jersey, Sterling Medical Devices Makes Med Tech to Order

Dan Sterling of Sterling Medical Devices | Screenshot by Esther Surden Suppose you are developing an implant that involves both hardware and software, or an external device for diagnosing a...
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healight

November 5, 2020

Healight: The Moonshot Not Yet Heard Round the World

Imagine a technology so innovative and groundbreaking in its potential impact that its sponsor is calling it “a moonshot” and “an opportunity so big you could build an entire company around...
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