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LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
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…
The skinny
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