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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

ISO 10993-1: a matchmaker guide for a biologically safe relationship between a medical device and a patient

Published Date: July 13, 2023

How to evaluate a potential biologically safe relationship between a medical device and a patient, is a challenging question that needs to be addressed for each new or modified device. This kick-off presentation highlights the importance of ISO 10993-1 in the matchmaking process using a 3-step approach: Plan, Test, Evaluate. In addition to this, you will understand how the different topics are linked to ISO 10993-1.

This presentation ‘ISO 10993-1: a matchmaker guide’, by Lise Vanderkelen, was recorded at the Open House seminar, in Leuven, in April 2023 and is part of a series of videos.

Lise Vanderkelen, PhD

Lise Vanderkelen, PhD

Pharmaceuticals and Microbiology Expert

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...

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