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What are the challenges and implications of MDR for medical devices and clinical software?
MDR (Medical Device Regulation) is a new EU regulation on medical devices and clinical software just delayed until May 26th 2021.
MDR has significant implications on manufacturers of medical devices and developers on clinical software. Companies not complying with the new MDR regulation must stop selling their products and services.
The first presentation shows how Otivio, a small medical device startup company, is handling the MDR challenges.
In the second presentation a certification and accreditation service provider, DNV GL, presents details on how MDR will impact the Clinical Decision Support (CDS) software industry, you may read more on bigmed.no (PDF)
Frederic Courivaud, from DNV-GL
Ira Sankhayan, Otivio