The Medical Device Single Audit Program (MDSAP): Your Questions Answered

Regulators from five countries (US, Canada, Australia, Brazil, and Japan) joined forces in 2012 with the goal of coordinating data gathering and reducing redundant audits for medical device manufacturers. The program has grown quickly. Health Canada led the way and required MDSAP certification starting in January 2019. At Oriel STAT A MATRIX we get many questions about MDSAP, so we have compiled a list of the most common ones. Questions and responses are grouped into the following categories. Who Needs […]

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All Topics, Auditing, MDSAP

Ready, Set, Score! Understanding the MDSAP Grading System

In this game, a high score is not the goal! The MDSAP grading system (MDSAP AU P0037) was established to address inconsistencies from traditional audit grading approaches like “major finding,” “minor finding,” and “opportunity for improvement” by establishing objective criteria to characterize the significance of findings that can be easily shared among participating Regulatory Authorities (RAs). How It Works During an MDSAP Audit, nonconformities are assigned a grade/score of 1 to 5 that is calculated using a two-step grading system. […]

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All Topics, MDSAP

Auditing Organization (AO) versus Notified Body (NB) versus Registrar. What’s the difference?

With the introduction of the Medical Device Single Audit Program (MDSAP), you may have heard the term “Auditing Organization” tossed around. It seems like a pretty generic term and most people assume that it is synonymous with Notified Body and Registrar. Are they the same? Are they different? Yes. Let us explain. While these terms are often used interchangeably, you should understand the differences in nomenclature. We detail these differences in the table below but here is a high-level overview. Notified […]

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All Topics, MDSAP

The Medical Device Single Audit Program: How to Prepare for (and Maintain) MDSAP Certification

The Medical Device Single Audit Program (MDSAP) is a cooperative effort between the medical device regulators in the US, Canada, Japan, Australia and Brazil. Argentina, South Korea, and Singapore participate as affiliate members. The challenges of preparing for your first MDSAP audit are substantial, but so are the long-term benefits. One audit allows you to meet the quality requirements of five major regulators. Unfortunately, Europe is not among them. Many people ask whether an MDSAP audit is more similar to […]

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All Topics, Auditing, MDSAP

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