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ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
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...
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 IVDR Are Live – Here Are Some Important Items You Should Know! - Featured Image

EU MDR and 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...
Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4 - Featured Image

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

European legislation requires medical device manufacturers to perform a conformity assessment of the...

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