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Category Archives: Clinical Evaluation
Europe Clinical Evaluation Guidelines SmackDown
The European Commission’s medical device conniption reached a frenzied pitch with the release of the Medical Devices Regulation (MDR) 745/2017 in May 2017.
Europe MDR General Safety & Performance Requirements vs. MDD Essential Requirements
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
