The new ISO 10993-1:2018 “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” has significantly impacted the approach to biocompatibility. This approach is now based on the review of relevant established scientific data, physico/chemical characterization and in vitro testing; in vivo testing is carried out only to fill gaps in our understanding. All device types will require a chemical characterization as a prerequisite for the risk assessment.
Data obtained from chemical characterization should be toxicologically assessed to elucidate the need for further tests to address the relevant biological endpoints.
In line with the risk management, the biological evaluation should be planned in advance (“Biological Evaluation Plan”), carried out and documented (“Biological Evaluation Report”) by knowledgeable and experienced professionals. Characterization studies are performed in order to gain a more complete understanding of a device, and of the risk factors associated with using a device. Also FDA is placing a greater emphasis on these studies – to better ensure patient safety.
This Workshop will provide a wide and comprehensive overview of critical aspects and latest updates on ISO 10993 series and the impact that on the medical devices industry. By attending, participants will gain valuable insight on how to plan and conduct the biological evaluation plan, and, more importantly, how such an evaluation sits within the activities of design control and risk management.
This Workshop, led by the biocompatibility industry expert in Eurofins, will also give the opportunity to bring your specific questions and case studies along to the Workshop for discussion. Benefit from the strong expert advice on how to overcome challenges and
implement successfully your biocompatibility testing strategy.