Category: MDSAP

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

MDSAP PlanningAs of January 1, 2019, medical device companies selling in Canada had to be certified as compliant with the Medical Device Single Audit Program (MDSAP). Of course, MDSAP is not just about Canada, but it so happens that Health Canada was the first to make it mandatory. The other four MDSAP participants— Japan, Australia, Brazil, and the US —may follow suit.

The challenges of preparing for your first MDSAP audit are substantial, but so are the long-term benefits.

One audit will allow you to meet the quality requirements of five major regulators.…

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All Topics, MDSAP

How Confidential Are MDSAP Audit Reports?

Download a comprehensive list of MDSAP FAQs and responses here.

ConfidentialAudit 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).…

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All Topics, MDSAP

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

Oriel STAT A MATRIX can help answer your questions about the Medical Device Single Audit Program.
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 Audit Program – or MDSAP – allows a single audit of a medical device manufacturer’s quality management system (QMS) to satisfy the regulatory requirements of Australia, Brazil, Canada, Japan, and the United States.…

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All Topics, Auditing, MDSAP

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 of audit times for certain medical device manufacturers.…

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All Topics, MDSAP
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