August 3, 2022
Speakers: Shayne C. Gad and Samantha Gad
Educational Level: Advanced, Practical

Over the last decade, testing requirements for medical devices have evolved immensely. Many device companies do not have internal toxicology or biocompatibility support to guide them through the testing and interpretation of the results. This webinar starts with a brief history of risk evaluation for medical devices, then dives into the fundamental principles of biocompatibility assessment. Topics include device categorization per ISO 10993-1 to determine what, when, and why some biocompatibility endpoints should be evaluated through testing, some evaluated via alternative methods, and some will require hazard analysis to identify risks not addressed through the prescribed testing. In the second half of the webinar the focus turns to chemical characterization (ISO 10993-18) and gas emissions testing (ISO 18562 series). What biocompatibility endpoints can be addressed through extractables testing with tox risk assessment, interpretation of test results to ensure risk is adequately addressed, and how to work with the data for estimating patient exposure and assessing risk -including when to use the TTC. This webinar will provide insight on medical device testing and methods that comes after years of practical application, spanning several generations of regulatory guidance and expectations.