Expert Session #29: Tackling the Regulatory Nightmare

​Medical device regulation is often seen as slow, complex, and incompatible with startups, something to deal with “later” once the product and funding are in place. From a venture builder and manufacturer perspective, this talk cuts through the noise and focuses on what really matters early on. It offers a high-level, end-to-end view of how MedTech and digital health products reach the European market, highlighting hard-to-reverse decisions such as when regulation actually starts, what qualifies as a medical device, and how early classification and design choices impact speed, cost, and flexibility. The session shares practical lessons from building real products, common startup mistakes, and concrete ways to stay compliant, investor-ready, and fast, without overengineering or slowing down innovation.

​About the speaker:

​Michael is a MedTech and Digital Health practitioner working at the intersection of product development, quality management and regulation with 18 years experience. He is the Founder of Evoleen Access, responsible with his team for Regulatory Affairs and Quality across the Evoleen venture platform and for external startups. He previously co-owned a company that was successfully exited and brings hands-on experience from navigating regulatory pathways for in-house and external medical devices