Clinical evidence for AI builders: the part of medtech nobody told you about

In this session we will discuss

• What "clinical evidence" actually means, in plain English, and why your AUC is necessary but not sufficient
• The three pieces every reviewer wants to see, clinical study, literature review, post-market monitoring, and how they fit together
• Where CE marking, DiGA, and the EU AI Act overlap, where they don't, and which one comes first
• The most expensive mistakes AI teams make before they ever talk to a regulator, and the cheap fixes that prevent them
• What a clinical study actually costs, takes, and looks like for a software-only product

Program
18:00–18:30 Arrival & networking
18:30–19:00 Main Presentation
19:00–19:20 Innovation pitches (If you want to pitch your innovation in future events, please contact us directly)
19:20–20:30 Networking

Topic will be presented by Nika Mendelev. She has 20+ years in medical device R&D and regulatory affairs, including Notified Body auditing. As a board member of the DIN “AI in Healthcare” Committee, she will share a practical view on what Health AI teams need to prepare for.