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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Chemical Characterization and Toxicological Risk Assessment for Medical Device Biocompatibility

Published Date: August 22, 2018

In this course you will learn what changes are occurring in regulatory standards, including ISO 10993, Medical Device Regulations, and FDA guidance. Then based on these changes you will learn how to keep your biocompatibility program current.

Using chemical characterization to support biocompatibility of medical devices has become a common occurrence. Not only through increased acceptance, but also through heightened requirements, Chemical Characterization per ISO 10993-18 of a medical device has become an essential component of overall biocompatibility. This talk will present the framework in which we understand and design these programs, illustrate how they are carried out, and close with an overview of how results are used within a toxicological risk assessment per ISO 10993-17.

Matthew Jorgensen

Matthew Jorgensen

PhD
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
Chemical Characterization of Medical Devices and Compendial Testing Expert

Annelies Vertommen holds a master’s degree in Biology and a Ph.D. in Bioengineering. She started her career at Nelson Labs as Study Director for extractables and leachables projects, gaining experience in the different application fields of the pharmaceutical industry. In recent years, she has focused on chemical characterization studies for the medical device industry. She...

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