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On-Demand Webinars



Learn from our experts on industry topics.



August 27, 2020

Discussion of Feedback Received Directly from FDA on ChemTox

We share trends in feedback received from the FDA regarding extractables chemistry testing, including the level of detail expected in...

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August 26, 2020

Meeting Requirement 10.4 of the MDR – How to Address CMRs?

We present a strategy to evaluate whether a medical device contains any carcinogenic, mutagenic, or reproductive toxicants (CMRs) at amounts...

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August 25, 2020

Shifting Requirements Within the FDA: Expectations in Chemistry Study Design

Expectations of the FDA regarding the design of chemistry studies in support of medical device toxicology has been shifting rapidly....

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August 13, 2020

Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a...

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August 7, 2020

Chemical characterization on a combination device form Biological Evaluation Plan to practice

During Medtech LIVE Dr. Annelies Vertommen and Dr. Sophie Michel presented: Chemical characterization on a combination device form Biological Evaluation...

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