As 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.… » Read more
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.… » Read more
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.… » Read more
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.… » Read more