A Strategic Roadmap Assessing Safety & Biocompatibility of Medical Devices

The regulatory landscape for the safety evaluation, clinical testing and commercial development of medical devices is undergoing considerable changes, including new requirements for material characterization and chemical risk assessment early on in the development process. In this webinar, toxicologist Dr. Joel Cohen (Gradient), and chemists Dr. Mark Jordi (Jordi Labs), and Dr. Jim Rice (Gradient) will discuss strategies for evaluating safety and biocompatibility of a device from the development stage through to market approval.

You will learn about:

Regulatory frameworks and guidance to establish that a medical device is safe for use in humans
The role of extractables and leachables testing in evaluating potential risks.
Non-targeted analytical methods that generate data adequate for toxicological risk assessment including extraction method design, analytical instrument/tool selection, selecting an analytical evaluation threshold (AET), sample manipulation, system suitability, calibration, identification/semi-quantification, and data reporting.
Predictive toxicology methods (e.g., computational toxicology programs, read-across, threshold of toxicological concern) for evaluating potential risks from extractable compounds.