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New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety

This presentation will provide a snapshot of a shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of the strategic options available for the evaluation of medical device biocompatibility will be provided, including the use of chemistry and biological risk assessments to save time, money, and spare animal life.

 

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...