Biocomp and Beer

Operating room with monitor

Published:

August 11, 2021

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.

In its third year, the North American Biocompatibility Summit (NABS) is a limited-seating event that provides industry insights and expertise sharing on the biocompatibility of medical devices. This year, sessions will include the latest regulatory updates, biological evaluation strategies and best practices that lead to successful biocompatibility programs in 2021 and beyond.

In this episode, our hosts discuss this upcoming event and what attendees can expect. This includes details on the NABS Scientific Advisory Board, abstract submissions and how the Board determined what educational opportunities to offer. Listeners will learn more about featured topics, including the overall theme that emerged from the abstracts.

Discussion points include:

  • What is the North American Biocompatibility Summit and how can one register
  • Expectations attendees can have from this event; from education to networking time.
  • The topics of the event including chemical characterization, toxicological risk assessment and alternative test methods
  • Registration details for the event

“The topics are universal to all medical devices.” Don Pohl

“We receive enough abstracts that we have more than enough to choose from and it’s interesting to see the trends in the industry of what people are struggling or dealing with.” Don Pohl

“There are no cupcake topics at this event, that’s for sure.” Sheri Krajewski

“It’s great to have this opportunity to get out and hear what everyone else is experiencing.” Don Pohl

“This is not just a Minneapolis event; anyone from anywhere is welcome to join us.” Sheri Krajewski

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Also be sure to check out our Biocompatibility Strategy Navigator.

Sheri Krajewski

Sheri Krajewski

Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. Sheri 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, she created the much sought-after NAMSA Training Series (NTS) for the iological 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

Don Pohl

Don Pohl is currently the Manager of Biological Safety & Validation at NAMSA. He holds a Bachelor’s degree from Ohio State University. Don has over 20 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.

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