Watch recent videos from our experts sharing the latest industry information.
Watch recent videos from our experts sharing the latest industry information.
July 24, 2019
Presenter: Audrey P. Turley
The approach to biocompatibility testing has changed as regulatory agencies from all around the world are expecting a risk-based approach to testing and justifications. This means that “check box” compliance...
Watch VideoJuly 4, 2019
Presenter: Annelies Vertommen
This presentation describes the basics of a chemical characterization study according to ISO 10993-18; reviewing the three major steps: extraction, detection, and identification. In addition, you will learn how ISO...
Watch VideoJuly 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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