Watch recent videos from our experts sharing the latest industry information.
Watch recent videos from our experts sharing the latest industry information.
July 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...
Watch Video
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,...
Watch Video
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 Video
