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Clinical Evidence for Medical Devices

This video covers Regulation (EU) 2017/745 with a special focus on the collection, generation and evaluation of clinical data for medical devices. Our expert, Dr. Kivia Pontes de Oliveira, gives you an insight on the following topics: • Requirements of Regulation (EU) 2017/745 on clinical data • Identification of clinical data sources • Equivalence route and clinical investigation route • Post-market clinical follow-up (PMCF) activities Dr. Kivia Pontes de Oliveira works at NSF International. She holds a doctorate degree in natural science from the Humboldt University of Berlin and has several years of professional experience in medical writing and clinical affairs.