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, and as of late 2019, nearly half of US manufacturers qualified for an MDSAP audit while the rest received traditional FDA inspections. At Oriel STAT A MATRIX we get many questions about MDSAP, […]

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All Topics, Auditing, 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 and South Korea 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 an […]

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All Topics, Auditing, MDSAP

How Confidential Are MDSAP Audit Reports?

Audit reports lay bare the good, the bad, and the ugly about a company’s current state of regulatory compliance. Questions have been raised about how Medical Device Single Audit Program (MDSAP) outcomes are shared among regulatory authorities. In the good ol’ days (circa 2017), if the US FDA did an inspection report, any dirty laundry or proprietary information contained in that report usually stayed in an FDA filing cabinet (assuming you were not issued a warning letter). Likewise, reports from […]

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All Topics, MDSAP

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