SOT ToxExpo 2025

Eurofins EAG Laboratories will have an Exhibitor-Hosted Session and exhibit in booth 1406, at the SOT 64th Annual Meeting and ToxExpo in Orlando, March 17-19, 2025.

Exhibitor-Hosted Session

• Session Title: Addressing Biological Equivalence for Modifications to Medical Devices
• Speakers:
  • Catherine D. Christensen, Principal Toxicologist and Biocompatibility SME, Medtronic plc
  • Steven R. Doonan, Ph.D, Eurofins EAG Laboratories
  • Chad P. Satori, Ph.D, Research Manager, Medtronic plc
• Date and Time: Tuesday, March 18: 9:15 AM–10:15 AM
• Room: W208A
• Session Description: This presentation will discuss a least burdensome approach for evaluating biocompatibility of changes to released medical devices per ISO/DIS 10993-1:2024. The authors will discuss strategy for biocompatibility evaluations of released products while managing test complexity, cost, and timeline, with an emphasis on reducing animal testing by leveraging biological equivalence. Appropriate test method selection will be discussed in detail, as it is a crucial step in generating quality data and meaningful project outcomes.
  
• Learning Objective: Participants will learn about essential considerations when establishing biological equivalence for changes to medical devices. Relevant test methods suitable for surface and chemical characterization will be discussed with an emphasis on the importance of system suitability, sensitivity, and acceptance criteria. Lessons learned from this developing approach will be discussed, including case studies and risk management strategies. 
• Authors:
  • Catherine D. Christensen, Medtronic plc, Minneapolis, MN
  • Whitney V. Christian, Medtronic plc, Jacksonville, FL
  • Steven R. Doonan, Ph.D, Eurofins EAG Laboratories, St. Louis, MO
  • Chad P. Satori, Ph.D,Medtronic plc, Minneapolis, MN