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Updates to ISO 10993-1 and ISO 21726

The approach expected by regulators for evaluation of medical device biocompatibility has been rapidly changing as expectations within regulatory bodies has been shifting. This shift is fueled in part by two newly minted standards: ISO 10993-1 and ISO 21726. This presentation will provide an overview of what is new with these two documents as they apply to manufacturers seeking to get a device onto market.

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...