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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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Matthew Jorgensen

Matthew Jorgensen

PhD, DABT
Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...

Annelies Vertommen

Annelies Vertommen

PhD
Scientific Improvement Manager

Annelies Vertommen holds a master’s degree in Biology and a Ph.D. in Bioengineering. She 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...