Category: All Topics

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

EU MDR Timelines: Common Questions Answered About 2017/745 Implementation Dates

Want to better understand MDD renewal “drop dead” dates? Then read our post on renewal certificate timelines.

If you have been looking at your upcoming device certification renewal dates or pondering a new product introduction, you may be perplexed about the timelines for MDR implementation and how to proceed. You are not alone.

Following are a few common questions our EU MDR consultants are hearing from our customers related to grandfathered devices, design changes, up-classification, and what happens to MDD-certified devices in distribution after 2020.…

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All Topics, EU Medical Device Regulation (MDR 2017/745)

The European IVDR Requirements – What You Should Be Doing Now to Prepare

This is our last blog post in a four-part series on the IVDR. You can read the first post detailing IVDD to IVDR changes, the the second post on technical documentation or the third post on conformity assessment and PMS requirements. Or, make it easy on yourself and download the entire series in one easy-to-read, shareable PDF.

While 2022 seems light years away, there are some really important reasons to take the IVDR seriously and start planning early…like now.

Here are some important things to consider.…

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All Topics, In Vitro Diagnostics & IVDR

IVDR Conformity Assessment, Postmarket Surveillance, and Vigilance Requirements

This is our third blog post in a four-part series on the IVDR. You can start with our first post detailing IVDD to IVDR changes, or the second post on technical documentation. Or even better download an easy-to-read, shareable PDF containing all four posts.

buccal cotton swab and test tube ready to collect DNA from the cells.

The EU’s new In Vitro Diagnostic Regulation (2017/746) (IVDR) places a significant new regulatory burden on IVD manufacturers.

Not only will 80-90% of all manufacturers be subject to ongoing Notified Body scrutiny, they will also be required to produce reams of premarket technical data in order to gain CE Marking under the IVDR.…

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All Topics, In Vitro Diagnostics & IVDR
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