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What is proactive PMS, and why is it necessary? The word “proactive” is used four times with respect to postmarket data collection in both the MDR and IVDR. Articles 2(60) and 2(63 ...
According to the European Union Medical Device Regulation (EU MDR 2017/745) Post-market surveillance (PMS) are set of activities conducted by manufacturers, to collect and evaluate experience gained ...
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