This course provides an in-depth exploration of the chemical characterization process essential for assessing the biocompatibility of medical devices. Participants will gain insight into the latest regulatory expectations worldwide, with a focus on compliance with ISO 10993-17, ISO 10993-18, and industry best practices.
The course will cover key areas, including the fundamentals of polymers and materials science, the extraction and data collection process for extractables and leachable’ s (E&L), and the toxicological risk assessment of E&L data.
Through a structured curriculum, participants will learn to navigate the complexities of chemical characterization step-by-step, ensuring they can effectively address regulatory requirements and enhance the safety profiles of medical devices.
