Project Lead for Regulatory Affairs, Software & AI at Metecon
Thorsten Stumpf is the Project Lead for Regulatory Affairs, Software & AI at Metecon and has been with the company for 13 years. He is a RAC Devices holder and has extensive experience in the registration of medical products across various global markets. His key areas of regulatory expertise include software in all its aspects, information security, UDI, regulatory strategies, and general regulatory requirements.
Recently, Thorsten collaborated with other experts on a cross-cluster project, “AI Meets MedTech,” contributing to a guidance document that addresses the challenges of the AI Act. This initiative was launched by Innovationsnetzwerk Gesundheit (Bayern Innovativ), Medical Valley EMN e. V., and BAIOSPHERE/KI Agentur.