Symposium Session on Medical Device Biocompatibility

Jeni Lauer, PhD, Biocompatibility Expert, Nelson Labs (bio)

Thursday, May 16th @ 2pm

Regulatory authorities and standards organizations are reassessing the guidelines and requirements involving the testing of medical devices, particularly in biocompatibility. This special session will cover the essentials of medical device biocompatibility, providing an overview of the guidance provided in ISO 10993-1 and FDA expectations for demonstration of biocompatibility. The session will also provide important background, updates and trends in biocompatibility, including:

• ISO 10993 series standards, updates, and the implications for current assessments.
• device changes and how to perform the biological risk assessment.
• MDR compliance hurdles and feedback.
• current trends in FDA feedback
• biocompatibility testing.

Quality Networking

Dynamic Keynotes

FDA & Industry Panels

The Florida Medical Device Symposium is Florida's premier event for medical device manufacturers and allied industries, featuring nationally recognized speakers, key FDA staff and officials, expert panels on regulatory issues and industry trends, exhibiting companies, legislative updates and quality networking opportunities.