biocompchatibility

Introducing NAMSA’s “BiocompCHATibility” Podcast!

NAMSA is excited to present a new podcast series dedicated to all things biocompatibility!

Medical device professionals tasked with proving biological safety are dedicated to the demonstration of product and material safety to improve patient healthcare around the world. However, there are often unforeseen challenges and roadblocks surrounding the biological safety evaluation of medical products—from updated regulatory standards and expectations to new advances in testing methodologies—it can be difficult to stay up-to-date on the latest industry information and trends.

Join NAMSA for a first-of-its-type podcast series, “BiocompCHATibility,” as each episode features leading industry experts and discussion on how to proactively address specific medical device evaluation scenarios and challenges. Experts will also share real world examples and experiences focused on solutions proven to be successful.

Also be sure to check out our Biocompatibility Strategy Navigator.

Host Information

 

Sheri Krajewski-Bibins

Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl

Principal Product Development Strategist, NAMSA

Don holds a Bachelor’s degree from Ohio State University. He has over 25 years of experience in the pre-clinical 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 for Biological safety and biological risk assessment consultation. 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.