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Tuesday, February 5 | Room: 209B

8:30 a.m. - 9:10 a.m.
ISO 10993-1 2018 Updates: What Are The Relevent Changes and How It Impacts The Biocompatibility Safety Evaluation Process for Medical Device Manufacturers

9:10 a.m. - 9:50 a.m.
Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety

9:50 a.m. - 10:30 a.m.
EU MDR - Are You Prepared? It's Not Too Late. The Session Will Review The General Safety & Performance Requirements of the EU MDR for The Biocompatibility of Medical Devices

10:30 a.m. - 10:45 a.m.
Break

10:45 a.m. -11:15 a.m.
"New" Testing Methodologies That Can Minimize Degradation and Maximize Extractable Compounds, and Are You Selecting The Best Solvents for Your Extractable Testing and Do You Get The Most Out of Your UPLC-MS?

11:15 a.m. - 11:45 a.m.
Ask The Experts/ All

Speakers:
Don Pohl, Manager of Biological Safety and Validation, NAMSA
Dr. Phillip Smiraldo, Ph.D., DABT, Medical Research Scientist, NAMSA
Angela Sanchez, Principal Chemist, NAMSA

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