Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by Notified Bodies and Competent Authorities...
Resources
REGISTER NOW: Conducting a Medical Device PMCF Study
The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting...
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WATCH NOW: Medical Device Registration in Mexico
Mexico is one of the largest medical device importers in the world, making it an...
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