Biocompatibility Studies: Prepare For Change

The medical device industry continues to evolve under rapidly changing regulatory requirements, making it essential for professionals to stay ahead of biocompatibility testing developments. Biocompatibility Studies: Prepare for Change, brings together industry experts to provide critical updates and practical insights.

The session highlights the collaboration between Eurofins and Product Safety Labs, offering participants an inside view of how coordinated testing strategies streamline medical device safety evaluations. Key regulatory updates are explored, including revisions to ISO 10993, the removal and reconsideration of pyrogenicity testing, and new guidance on exposure duration measurement. Additionally, viewers will gain valuable insights into the FDA’s draft guidance on extractables and leachables (E&L) testing, with practical discussions on solvent selection, analytical methods, and implications for prior studies.

The importance of integrating both in vitro and in vivo methods for comprehensive safety assessment is emphasized, along with the role of Biological Evaluation Plans in ensuring compliance. Designed for medical device professionals, toxicologists, researchers, and quality assurance experts, this webinar equips attendees with the knowledge and strategies needed to adapt their testing protocols, address regulatory challenges, and ensure patient safety in a changing landscape.