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How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers - Featured Image

How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers

By Jon Speer on October 16, 2017
Up until the latest revision of MEDDEV 2.7.1 was published on June 29th, 2016, clinical data provide...
Design Validation vs. Clinical Evaluation: What’s the Difference? - Featured Image

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

By Jon Speer on June 30, 2017
How confident are you when it comes to design validation? Does this always involve clinical evaluati...
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

By Florian Tolkmitt on May 11, 2017
European legislation requires medical device manufacturers to perform a conformity assessment of the...

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