Description
Info from event page: "Software and artificial intelligence are no longer add-ons in healthcare solutions. In many cases, they are the product. At the same time, regulatory expectations under the Medical Device Regulation, In Vitro Diagnostic Regulation, and the new EU AI Act are developing rapidly. For innovation-driven teams, understanding how these frameworks interact is essential for successful development and commercialization.On March 17, BioPhoT project teams, technology transfer professionals, researchers, and developers working with digital health, software as a medical device, and AI-based diagnostics are invited to join a focused webinar on the European regulatory framework for software and AI/ML-based medical technologies. The session will provide a structured overview of qualification, classification, and compliance requirements, with practical insight into what this means for early-stage and scaling projects.
The webinar will be led by Stefan Bolleininger, Managing Director and Senior Regulatory Consultant at Consultys Medical. With extensive experience supporting startups, research institutions, and innovation ecosystems across Europe, he specializes in navigating complex regulatory landscapes and translating regulatory requirements into workable strategies for market access.
What you will learn:
How to determine whether your software qualifies as a medical device or IVD under MDR/IVDR
How classification rules apply to software as a medical device (SaMD) and IVD software, and what this means for regulatory obligations
What is required for conformity assessment, including technical documentation, cybersecurity, and clinical or performance evidence
Which standards are relevant for software and AI, including IEC 62304, ISO 14971, and IEC 82304-1
What regulatory expectations apply to AI and machine learning systems, including data governance, transparency, and validation
How the EU AI Act interacts with MDR/IVDR and what dual compliance means in practice"
| Period | 17 Mar 2026 |
|---|---|
| Event type | Webinar |
| Degree of Recognition | National |