Human Body Meets Medical Device: Are We Biocompatible?
Tuesday, September 12, 2023 (2:00 PM - 3:00 PM) (EDT)
Join us on Tuesday, September 12 at 2 PM ET for this 60 minute webinar, presented by PLAC and Exponent. Biological risk and biocompatibility of medical devices and their materials are coming under increasing scrutiny with recent vigilance from regulatory agencies, recalls, and litigation. Join us for a discussion of the impact of material selection and biological assessment and practical guidance on mitigating regulatory and litigation risk.
The session will cover:
•Foundations of biocompatibility: what it means, how it is determined, current best practices
•Developments in FDA analysis of biocompatibility
•Litigation impact of biocompatibility and strategies for telling the story of biocompatibility
•Emerging issues in the regulatory and litigation contexts