Stephen Gilbert is a leading expert in medical device regulatory science at the Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, where he leads interdisciplinary research on regulatory frameworks for digital and AI-enabled medical technologies. Originally trained as a veterinarian at the University of Glasgow, he later earned a Master’s in Biomathematics, Bioinformatics and Computational Biology from the University of Leeds, followed by a PhD in computational biology. After a decade in veterinary practice, he transitioned into industry roles, including Clinical Evaluation Manager at Biotronik and Clinical Evaluation Director at Ada Health in Berlin, focusing on regulatory and clinical aspects of innovative implants and AI-based health technologies. In 2022, Stephen returned to academia to pioneer regulatory science in Germany’s first medical faculty-based professorship in this field. His research aims to modernize regulatory pathways for software as a medical device and adaptive AI systems, with key interests in the European Health Data Space, digital/AI-drug product integration, and digital twins as a future healthcare paradigm