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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, 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. To characterize materials, Dr. Jorgensen has extensively used a wide variety of techniques including GC/MS, LC/MS, FTIR, UV/VIS, SEM, NMR, and several types of advanced spectroscopic techniques. His research has resulted in...

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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.

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