Event Information

Event Topic:
The new ISO 10993-18 and updates to regulatory expectations regarding chemistry in support of medical device biocompatibility

Event Description:
The basic theory of how medical devices should be evaluated for biocompatibility has been in a period of flux. A cornerstone of the new ISO 10993-1:2018 is that evaluation should be focused on a rational and risk-based approach that minimizes unnecessary animal tests. A large part of that approach relies on the use of chemistry and material information to make determinations regarding biocompatibility. Changes to standards (ISO 10993-18) and regulatory policy have complicated this process. This presentation will highlight some key points in the new draft of ISO 10933-18 and provide recent examples implementing these changes in biocompatibility submissions to the FDA.

Date/Time:
Date(s) - 12/03/19
8:30 am - 10:30 am

Event Location:
NOVA - 505 West Olive Ave, Sunnyvale- Suite 799:

Speaker Information

Event Speaker:
Matthew Jorgensen

Event Speaker Title:
Materials Scientist/Chemist

Event Speaker Company:
Nelson Labs

Event Speaker Bio:

Dr. Jorgensen is a seasoned scientist with a diverse background in chemistry and material sciences. Currently he focuses his efforts on using extractable and leachable chemistry in the evaluation of medical device biocompatibility. His academic work focused on synthesis and characterization of biomimetic materials, fabrication of microscale devices, and photonics. He has a professional interest in both technical and popular science writing, which has produced over 30 peer reviewed scientific articles and hundreds of blog articles. Matt got his PhD in Physical Chemistry from the University of Utah. During his time at the University of Utah, he received the Henry Eyring Research Fellowship, the DOW Chemical First Year Scholarship. Dr. Jorgensen taught Quantum Mechanics and Thermodynamics as an assistant professor at Southern Utah University. Following his time at Southern Utah University, he received an Alexander von Humboldt research fellowship and worked at the Leibniz Institute for Solid State and Materials Research in Dresden.

Event Details

Cost:
$0

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