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

July 7, 2015

Should the FDA’s Regulatory Oversight of Medical Device Apps be Limited Any Further?

The medical technology (medtech) sector is ablaze with change as a result of the increased usage of mobile apps. Today, legislators, media outlets, and decision-makers in industry are increasingly...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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