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Digital Evidence Generation: FDA Perspectives on Computer Simulations in the Evaluation of Medical Devices

Webinář na vyžádání | 58 minut

Learn about the FDA’s perspectives on the use of simulation (digital evidence generation) in the development and regulatory evaluation of medical devices.

Digital evidence generation is the process of using simulation (the Digital Twin) to establish product performance—an effort supported by the FDA and regulatory agencies worldwide.

FDA acknowledges the benefits to public health provided by modeling and simulation, and routinely advises the medical device industry on the use of simulation methodologies so that safe and effective new therapeutics can advance more efficiently, from design to preclinical studies through clinical trials to market.

In this webinar, FDA’s Dr. Tina Morrison, Deputy Director, Division of Applied Mechanics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, provides an overview of those methodologies and highlights the possibility for in silico clinical trials to be used for evaluating medical products.