Risk-based approach to Biocompatibility evaluation strategy ·
Overview of current ISO 10993-1 and collateral standards Biocompatibility testing guidelines, costs, and turnaround times.
Chemical characterization, leachables and extractables (L&E) testing, and toxicology assessments.
Alternative testing to costly and time-consuming long-term animal testing.
Organized by:
ComplianceOnline
Invited Speakers:
Mike has over 30 years’ experience developing medical devices and systems. Over his career he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and startups.
Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology
Deadline for Abstracts:
16.2.2021
Registration:
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