Speaker: Natalia Szychulska, Founder, Regvo Ltd
Date: Tuesday 10 November 2026
Time: 12:00–13:30
Location: Emmeline Suite, Christabel Pankhurst Institute, University of Manchester
Format: Lunchtime-friendly, attendees are welcome to bring their own lunch
AI is transforming healthcare, but at what point does an AI tool become a regulated medical device?
This practical session is designed for researchers, innovators and start-ups developing AI-enabled healthcare technologies. It will explore where the regulatory boundary sits, what changes once a technology becomes a medical device, and why regulatory decisions made early in development can save significant time, cost and rework later.
Topics will include intended purpose and classification, moving from an AI prototype to a regulated medical device, the costs of compliance, and how the EU MDR and AI Act interact.
The session will be particularly relevant to researchers, spin-outs, AI and software developers, healthcare innovators and early-stage MedTech founders. No previous regulatory knowledge is required.
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