Evaluating the biocompatibility of medical devices is a critical step in ensuring patient safety, and it should be based on a risk assessment approach rather than a simple check-box method. This webinar will focus on how to construct a Biological Evaluation Plan (BEP) in accordance with ISO 10993-1 (2018), emphasizing the importance of a thorough and systematic risk-based evaluation.
Viewers will learn the essential elements of developing a comprehensive BEP, starting with an understanding of the types and duration of patient contact. The presentation will demonstrate how gathering detailed information about the device’s intended use and patient interactions is crucial for defining an appropriate biocompatibility testing program.
The session will guide attendees through the process of identifying potential risks associated with the medical device, including material composition, manufacturing processes, and the environment in which the device will be used. By assessing these factors, manufacturers can determine the necessary biocompatibility tests that address specific risks, ensuring that patient safety is maintained.
Key aspects of constructing a BEP will be covered, including the selection of relevant biocompatibility endpoints, designing a testing strategy that aligns with regulatory requirements, and documenting the rationale behind testing decisions. This structured approach helps ensure that all potential biological risks are identified and mitigated effectively.
The webinar will also highlight common pitfalls in biocompatibility assessment and offer strategies to avoid them. Attendees will gain insights into best practices for gathering and interpreting data, as well as how to integrate risk management principles into the biocompatibility evaluation process.