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Medical Device Single Audit Program (MDSAP) Internal and Gap Audits

ANSWERED ON THIS PAGE:

  • What are the requirements for the Medical Device Single Audit Program (MDSAP)?
  • Which countries are participating in the MDSAP?
  • How can we achieve MDSAP certification?

The Medical Device Single Audit Program (MDSAP) is designed to streamline quality system compliance by allowing device companies to meet requirements in participating markets through a single audit. Now that the pilot phase of the program is over, more companies are seeking MDSAP certification to expand their market reach.

Emergo has successfully implemented medical device quality management systems (QMS) in all MDSAP participating markets. We can help you adapt your QMS to meet MDSAP audit requirements.

MDSAP requirements for medical device companies

MDSAP requirements align with ISO 13485 along with supplemental QMS requirements in participating markets. You can leverage MDSAP certification to meet regulatory requirements in five major markets:

  • Australia
  • Brazil
  • Canada (only MDSAP audits will be accepted after December 31, 2018)
  • Japan
  • United States

Audits are conducted by MDSAP-recognized Auditing Organizations (AOs) in a three-year cycle. Your selected AO will conduct an initial certification audit followed by annual surveillance audits. After three years, your AO will conduct a recertification audit.

Identifying your MDSAP certification scope

Manufacturers only need to apply for MDSAP certification in countries where they currently (or plan to) market their devices. However, it’s important to consider your current compliance requirements and your long-term objectives when defining the scope of your MDSAP certification effort. Expanding your MDSAP certificate to other member markets will require QMS changes to add supporting documentation and a recertification by your AO.

Emergo provides internal and gap audits to MDSAP requirements

With offices in all MDSAP member markets, Emergo is uniquely qualified to assess your quality system for MDSAP audit readiness. We are experts in ISO 13485 implementation and audits and can identify the steps you must take to obtain MDSAP certification. Here’s how we can help:

  • Perform independent audit to determine your company’s conformity or nonconformity to ISO 13485:2003 / 2016 and the quality and regulatory requirements of Australia, Brazil, Canada, Japan, and the US;
  • Verify through interviews and objective evidence that the documented processes are followed and effective;
  • Evaluate control over critical suppliers and review adverse event reporting / recall / advisory notice information per country;
  • Prepare a written audit report of our findings.

Get more information about how we can help you leverage MDSAP certification to meet quality requirements in major markets around the world.