Virtual Medtech Happy Hour: A Risk Based Approach to Biocompatibility

We will be discussing ISO 10993-1: Biological Evaluation of Medical Devices and how to properly deploy a risk based approach to evaluating the toxicological endpoints that must be addressed to properly ensure your product is biocompatible.

About the Speaker: Don Pohl, Principle Product Development Specialist at NAMSA

Don holds a Bachelor’s degree from Ohio State University and has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager/manager for the Biological Safety and Validation team at NAMSA and a consultant specializing in the biocompatibility assessment of medical devices. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.