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7 Questions About the European MDR Answered - Featured Image

7 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

One thing that seems to be constant in the global medical device industry is change.
EU-MDR and EU-IVDR Are Live – Here Are Some Important Items You Should Know! - Featured Image

EU-MDR and EU-IVDR Are Live – Here Are Some Important Items You Should Know!

After almost 10 years of careful deliberations, the new EU regulations on medical devices finally ha...
A Revised Guideline for Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4 - Featured Image

A Revised Guideline for Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4

Editor's Note: This article was originally published by  Florian Tolkmitt on Medium and is being rep...

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