Watch recent videos from our experts sharing the latest industry information.
Watch recent videos from our experts sharing the latest industry information.
July 2, 2019
Presenter: Thor Rollins
Every medical device manufacturer must conduct the Big Three biocompatibility tests, or provide justification why the tests were not performed. The Big Three tests include cytotoxicity, irritation, and sensitization. Cytotoxicity...
Watch VideoJune 4, 2019
Presenter: Matthew Jorgensen
The approach expected by regulators for evaluation of medical device biocompatibility has been rapidly changing as expectations within regulatory bodies has been shifting. This shift is fueled in part by...
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February 22, 2019
Presenter: Matthew Jorgensen
The new Medical Device Regulation (MDR) become enforceable May 2022. After that, all new devices set for market in the European market will have to demonstrate compliance with ISO 10993,...
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December 19, 2018
Presenter: Audrey P. Turley
Many devices are a modified version of the “clean slate” device that was placed on the market decades ago and devices frequently change hands from one company to another and...
Watch VideoDecember 10, 2018
Presenter: Matthew Jorgensen
This presentation will provide a snapshot of a shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of...
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