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Medical Device Extractables and Leachables Testing in 2020

Published In: MD+DI

Chemistry for toxicology (ChemTox) testing has evolved considerably in the last couple years. Here’s what you should consider for your own program.

The world of physics has a foundation built on beautiful universal constants, things like π and ε0, which work their way steadfastly into virtually every aspect of modern life. Ironically, universal constants form the foundation of life for which it is popularly said that the only constant is change. Over the past 5 years, the medical device community has swung from nearly full ignorance of the potential power of chemistry testing to full adoration and acceptance, and now back—in a sense—to a state of scrutiny and skepticism.

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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.