Kimberley Peven
Clinical Engineer
Scarlet
United Kingdom
Kimberly Peven is a Clinical Evidence and Regulatory Specialist at Scarlet. Through her role, she has evaluated clinical evidence and performance data for a wide range of software and AI medical devices. Her background is as a Registered Nurse in the US and has a master's degree in Public Health and a PhD in Epidemiology, bringing a strong clinical and evidence-based perspective to the evaluation of emerging medical technologies.
Topics
Next-level conformity assessment for AI medical devices
Developing Health Technology
Regulatory Compliance on AI
6.2.2026 10:25 - 11:10 | 205 - Mylab
Artificial intelligence is increasingly embedded in software medical devices, challenging established approaches to conformity assessment. This talk explores how clinical evaluation and evidence expectations are evolving to keep pace with AI-driven technologies. The session highlights common pitfalls and emerging best practices in clinical evaluation and assessment of AI medical devices.