LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
Let's Talk Risk! Podcast
- Published
- February 6, 2026
- Duration
- 27:51
- Summary source
- description
- Last updated
- Apr 29, 2026
Discusses Summary“For years, clinical evaluations were mostly a story. What was missing were clearly defined o…
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…
Show notes
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 f