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

Unless you’ve spent several 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 Audit Program […]

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Smaller Medical Device Companies May Qualify for a 35% Reduction in MDSAP Audit Duration…If They Meet These Four Criteria

On October 31, 2017, Health Canada announced new guidelines intended to reduce some of the burden that the new MDSAP rules placed on smaller medical device companies. At that time, they promised a 10-20% reduction in audit times for companies with fewer than 45 employees. However, it seems industry was unimpressed with those efforts, because now Health Canada is recommending even more changes to all members of the MDSAP Consortium (Australia, Brazil, Canada, Japan, US). These changes affect the duration […]

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Health Canada Realizes That MDSAP Audit Deadlines Are a Burden for Manufacturers. Here’s How They Are Helping.

The Medical Device Single Audit Program (MDSAP) implementation date seemed light years away when it was first announced in late 2013. But with a January 1, 2019 deadline looming, officials at Health Canada are hearing that many manufacturers simply won’t be ready in time or, even worse, have decided that the cost and hassle of dealing with MDSAP isn’t worth the effort to sell in Canada. Cognizant of the challenges faced by industry, officials are trying to help…kind of. Health […]

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