Ilkka Juuso
Topics
Key Components of Good Clinical Evidence for AI Devices
A practical approach to the clinical evidence of AI/ML-based medical devices, including the role of international standards in the evidence. A notified body perspective.
Mind the Gap – Navigating the Regulatory Metro Map
Medical device regulations, standards and guidance documents often appear to form an overwhelming maze of overlapping, sometimes contradictory requirements. But what if we stopped looking at them as separate obligations and started seeing them as an interconnected transport network?
Welcome aboard the Regulatory Metro, where MDR, IVDR, AI Act, ISO 13485, IEC 62304 and other regulatory frameworks become routes through the medical device lifecycle. Using an interactive map inspired by Berlin's public transport network, this session explores how requirements intersect, reinforce one another and contribute to a common destination: safe, effective and compliant medical devices.
Along the journey, we will discover the major interchange stations, navigate regulatory bottlenecks and demonstrate how a single development activity can satisfy multiple requirements. Rather than treating compliance as a collection of checklists, we will explore how development processes generate evidence that serves multiple regulatory purposes.
Mind the gap, change trains when necessary, and discover how understanding the network can make even the most complicated regulatory journey surprisingly logical.