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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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 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 FDA […]

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How Confidential Are MDSAP Audit Reports?

Download a comprehensive list of MDSAP FAQs and responses here. 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 […]

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The MDSAP Audit Model: What to Expect and How to Prepare

Unless you’ve spent the last few years adrift on a raft in the South Pacific, you’ve probably heard about the Medical Device Single Audit Program, known as MDSAP. At Oriel STAT A MATRIX, many of our medical device clients ask us about the program, how to prepare for it, and how an MDSAP audit differs from a typical ISO audit or FDA inspection. Before we get into that, let’s take a step back. What is MDSAP? The Medical Device Single […]

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