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Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now - Featured Image

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

By Jon Speer on March 22, 2020
With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...
5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

By Tom Rish on January 12, 2020
It has long been thought that the quickest path to market for medical device manufacturers is to acc...
Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know - Featured Image

Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know

By Jon Speer on June 9, 2017
Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...

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