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Chemical Characterization for Medical Devices: The Basics

This presentation describes the basics of a chemical characterization study according to ISO 10993-18; reviewing the three major steps: extraction, detection, and identification. In addition, you will learn how ISO 10993-18 and ISO 10993-17 are related.

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Annelies Vertommen

Chemical Characterization of Medical Devices and Compendial Testing Expert

Annelies Vertommen started her career at Nelson Labs as a Study Director for extractables and leachables projects for the pharmaceutical industry. In recent years, her focus changed to chemical characterization studies for the medical device industry. She closely follows all changes in this field by actively participating in the ISO10993-18 committee and following the discussions in the ISO 10993-17 committee.