Watch recent videos from our experts sharing the latest industry information.
Watch recent videos from our experts sharing the latest industry information.
March 2, 2020
Presenter: Wendy Mach
This presentation will take a look at some of the recent Packaging trends that are outlined by increased 483 letters to medical device manufacturers. Additionally an examination into how to...
Watch VideoNovember 8, 2019
Presenter: Audrey P. Turley
In light of recent changes that are impactful to the realm of biocompatibility, including the new Medical Device Regulation (MDR) out of Europe and ISO 10993-1, this is a frequently...
Watch VideoJuly 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...
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