Episode
LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
- Podcast
- Let's Talk Risk! Podcast
- Published
- Feb 6, 2026
- Duration seconds
- 1671
- Processing state
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Summary
Summary “For years, clinical evaluations were mostly a story. What was missing were clearly defined outcome parameters, something measurable that connects the state of the art to benefit–risk conclusions.” In this Let’s Talk Risk! conversation , host Naveen Agarwal welcomes back Florian Tolkmitt , Managing Director of Pro-Liance Global Solutions, for a timely and highly practical discussion on clinical evaluation for medical devices. The conversation centers on the newly released draft ISO standard for clinical evaluation (ISO/DIS 18969), why it was developed, and what problem it is trying to solve. Florian shares first-hand insight from his role in the ISO working group, highlighting common industry misunderstandings, especially around outcome parameters, state of the art, and the linkage between clinical evaluation and ISO 14971 risk management. Together, Naveen and Florian unpack new terminology such as clinical risk , clinical outcome parameters , and available knowledge , clarifying how these concepts are meant to sharpen focus on patient-relevant benefit–risk decisions without overloading clinical evaluation with non-clinical risk data. The episode closes with practical reflections on how manufacturers, especially those struggling with EU MDR expectations, can use this process standard to strengthen their clinical evaluation approach. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 Welcome and introduction to the topic of clinical evaluation 01:25 What companies still get wrong about clinical evaluation 03:10 Overview of the new ISO/DIS 18969 draft standard 05:30 Why the standard is process-focused, not regulatory 06:20 ISO 14971 as a normative reference and the idea of “clinical risk” 10:20 State of the art vs.…