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Medical Device Preclinical Bootcamp – Bedford
February 13, 2019 @ 9:30 am - 4:30 pm
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
15 Wiggins Ave,
Bedford, MA 01730
Phone: (781) 275-3330
- 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