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LIVE WEBINAR

Navigating the New USP Class VI: Going Animal Free in Medtech

June 11, 2025

1:00 pm EDT

Thor Rollins and Chad Summers

As the medical device industry shifts toward more ethical and sustainable practices, the transition away from animal testing has become a pressing priority. The recent updates to USP Class VI (Section <88>) testing standards reflect this evolution, offering new guidance that significantly impacts both manufacturers and suppliers across the healthcare ecosystem.

This webinar will provide a comprehensive overview of the changes to USP Class VI, with a focus on the implications of eliminating animal testing and a new claim as pharmaceutical grade plastics in materials used for medical devices. Experts will break down the regulatory nuances, testing methodologies, and practical steps needed to remain compliant while embracing animal-free alternatives. Whether you’re involved in product development, quality assurance, or regulatory affairs, this session will equip you with the knowledge and strategies to successfully navigate the updated requirements.

Key Learning Points:

  • Understand the Evolution of USP Class VI: Learn what’s changed in the latest updates, particularly around testing requirements.
  • Compliance Pathways: Discover how to align your materials and processes with the new USP expectations and claim materials as pharmaceutical grade.
  • Testing and Certification Strategies: Get clarity on testing protocols and documentation to ensure your products meet the updated USP Class VI criteria and new certifications.
  • Impacts on the Supply Chain: Understand the upstream and downstream implications for suppliers and manufacturers—and how to communicate effectively across the value chain.
  • Future-Proofing Your Products: Learn how embracing animal-free practices not only meets compliance but also supports sustainability, ethics, and global market trends.

Learn more about the presenters below.

Thor Rollins

Thor Rollins

RM (NRCM)
Biocompatibility Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

Chad Summers

Sr. Manager, Scientific Business Development

Chad Summers is the senior technical sales manager for biocompatibility and a recognized industry leader for in-vitro and in-vivo testing. He has 29 years of experience working in, and running an in-vitro lab and has worked with our clients to increase access to safe and effective medical devices. Chad is an active committee member of many working groups within AAMI and is a nominated subject matter expert participating with the FDA OSEL outreach for cardiovascular safety.

Sean Fenske

Editor-in-Chief, MPO/ODT

Offering over 20 years of experience in medical journalism with more than 18 specifically focused on the medical device and healthcare technology sectors, Sean Fenske is an industry veteran within medtech publishing. He joined Rodman Media in November of 2015 as editor of Medical Product Outsourcing and Orthopedic Design & Technology magazines. He’s authored articles and blogs on technology trends, new innovations, industry challenges, and future outlooks as related to the space. Fenske has hosted video news casts on emerging medtech and moderated webinar and online roundtable discussions. When not seeking to increase his ever growing stable of industry thought leader contributors, Fenske spends time with his family in New Jersey.