An upcoming seminar will explore the preclinical testing pathway for medical devices. The event will cover everything from concept to regulatory submission, including relevant regulations and standards, as well as the role each type of test plays in the overall testing program. It will also provide practical information to help device manufacturers facilitate getting a proposed device submitted efficiently.

The seminar will be presented by Toxikon scientists who not only perform world-class medical device testing but who also help develop the industry regulations that govern testing programs. The bootcamp will take place March 30, 2018, from 9:30 am to 2:30 pm EDT.

Bootcamp Agenda

  • The Medical Device Approval Pathway
  • The Basics of Biocompatibility Testing
  • Chemical Characterization of Medical Devices: Strategies, Pitfalls, and Points of Consideration
  • Toxicological Risk Assessment Based on Extractable/Leachable Data: Why, When, and How
  • Toxicological Risk Assessment for Breathing Gas Pathway Medical Devices: ISO 10993 and ISO 18562
  • Tips for a Successful Sponsor-Laboratory Partnership

To register for the seminar, go to Educational Seminar: Medical Device Preclinical Bootcamp