The emerging regulatory framework for in silico medicine

In this seminar, open to all students and staff of the University of Sheffield and of the Sheffield Teaching Hospital NHS Foundation Trust, Professor Marco Viceconti presents a systematic review of the current regulations for medical software, stand-alone software as a medical device, and patient-specific predictive software which was.conducted with the students of the module BIE6432 “Regulatory Affairs for medical devices” Professor Viceconti will also review the emerging American and European regulatory frameworks in relation to the use of modelling and simulation results in a regulatory submission for a medical device. Please note: the seminar will be filmed, and made publicly available afterwards.