Understanding Key Components of a Medical Device Clinical Evaluation

During this webcast, we review MED DEV 2.7/1 REV 4, MDR, and the medical device coordination group (MDCG) guidance regarding clinical evaluation. We review the stages and deliverables of clinical evaluation, as well as key components, including systematic literature review, post market surveillance, and post market clinical follow-up, and identify types of clinical data that can be used to support your device under MDR.
Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
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[@naturalanimalpedia]

Great contents!

[@OliviaCauvi]

Can you say a little bit about how this applies to class I devices, where clinical data may be limited and evaluations based mostly on preclinical data?