Medical Device Preclinical Bootcamp

Medical Device Preclinical Bootcamp

Toxikon’s educational events give you front-row access to the scientists who not only perform world-class medical device testing, but help develop the industry regulations that govern testing programs. Learn from our 40+ years of experience to help make your next test program a success.

During this complimentary workshop, we will explore the preclinical testing pathway from concept to regulatory submission, including relevant regulations and standards; the role each type of test plays in the overall testing program; and practical information you can use to facilitate getting your proposed device submitted efficiently.

 

Date, Time, and Location
Wednesday, February 13, 2019
9:30am - 4:30pm ET

Toxikon
15 Wiggins Ave,
Bedford, MA 01730
Phone: (781) 275-3330

 

Agenda

  • Introduction to 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
  • Reusable Medical Device Cleaning Validation
  • Tips for a Successful Sponsor-Laboratory Partnership