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5 Steps for Getting your CE Marking with EU MDR Requirements - Featured Image

5 Steps for Getting your CE Marking with EU MDR Requirements

It has long been thought that the quickest path to market for medical device manufacturers is to acc...
Medical Device Classification Guide - How To Determine Your Device Class - Featured Image

Medical Device Classification Guide - How To Determine Your Device Class

What I am about to share with you is a guide to medical device regulatory classification.
Should you Swipe Right or Left on your Notified Body? - Featured Image

Should you Swipe Right or Left on your Notified Body?

How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander? ...
8 Questions About the European MDR Answered - Featured Image

8 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
Design Validation vs. Clinical Evaluation: What’s the Difference? - Featured Image

Design Validation vs. Clinical Evaluation: What’s the Difference?

How confident are you when it comes to design validation? Does this always involve clinical evaluati...

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