Clinical Product Reviewer
Kiwa Dare
As a clinical and technical expert within Notified Body Kiwa Dare, Natascha conducts technical and clinical reviews of medical devices, monitors reviewing external medical experts and examines the relevance of the clinical data to other parts of the technical file. She studied Veterinary Sciences at the University of Utrecht and holds a PhD in the field of human Medicine. Her PhD thesis was on infrared imaging. Since 2012 she works with Kiwa Dare, where she played a large role in obtaining designation of Dare as a Notified Body under the Medical Device Directive, followed by designation to the Medical Device Regulation. She works as a clinical expert, product reviewer and decision maker for the Notified Body, in the field of active devices. She takes part in several external meeting groups and committees, such as the standardization committee on clinical investigation of medical devices and the expert group AI and medical devices of the Dutch Standards Institute and the advisory group on the Medical Devices Regulation. Natascha is a member of the board of the RAPS Netherlands Chapter.
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Application of Article 61(10), Non-Clinical Data, for SaMD and AI
Wednesday, May 8, 2024
10:25 – 11:25 CEST