Getting It Right the First Time: Accelerated Testing of Implantable Medical Devices

Accelerated testing of implantable medical devices is a critical part of any submission to the FDA for new device technologies. Unfortunately, a definitive correlation between in vitro accelerated life testing and in vivo experience can only occur after a device has been implanted in a human. Therefore, medical device manufacturers must take considerable care when developing accelerated tests so that they have the utmost confidence that their testing was appropriate and can serve as an adequate predictor of how the device will perform in-vivo.

This presentation will discuss the various challenges associated with accelerated testing, and will review some of the complex considerations that need to be taken into account when developing an appropriate suite of accelerated tests to estimate the service life of active, implantable medical devices.

This 60-minute webinar is designed for implantable medical device manufacturers and the attorneys, both in-house and outside counsel, that represent them. There is no fee for this program, however, early registration is recommended.

Speakers

Eric P. Guyer, Ph.D., P.E., Managing Engineer
Mechanical Engineering and Materials/Metallurgy, Menlo Park, CA

Lawrence E. Eiselstein, Ph.D., P.E., Principal Engineer
Mechanical Engineering and Materials/Metallurgy, Menlo Park, CA

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