Stephen Gilbert

Professor of Medical Device Regulatory Science, Dresden University of Technology

Stephen Gilbert is Professor of Medical Device Regulatory Science at the Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden where he teaches and conducts research on regulatory science with a team of colleagues. He worked in senior MedTech and Digital Heath roles in industry for 5 years, before returning to academia in 2022.


His research goal are to advance the regulatory science of software as a medical device and AI-enabled medical devices. Innovative digital approaches to healthcare must be accompanied by innovative approaches in regulation to ensure speed to market, to maximum access of patients to life saving treatments whilst ensuring safety on market. My main research interests are in: (i) data sharing and the European Health Data Space; (ii) approaches to market approval of adaptive AI enabled medical devices; (iii) drug<->digital/AI-enabled medical device product realisation; (iv) digital/virtual twins: as an organising concept of the future of healthcare