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 R 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 research has focused on the intersection between chemistry, materials, and physics – fabricating structures with special micro- and nano-patterning to introduce novel functionality. His research has resulted in over 30 peer-reviewed publications.
Annelies Vertommen, PhD
Senior Study Director
Nelson Labs Europe (Focus on Chemical Characterization of Medical Devices and Compendial Testing)
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 is team leader of study directors specialized in the set-up of studies according to ISO 10993-18 in the broader context of ISO 10993-1.
Besides her activities in the field of medical devices, Annelies also leads the group of study directors focusing on compendial testing according to the current US, European and Japanese Pharmacopoeia.
With her group, she follows all changes in the regulatory field by interacting with the respective committee members and by attending and presenting at several conferences in the two domains.