In this episode of MedTech Global Insights, we dissect the essential requirements of ISO 10993-1 for the biological evaluation of medical devices. We explore the critical shift from a simple checklist to a comprehensive, risk-based approach, which is now the gold standard for regulatory bodies worldwide. We break down what this risk management process entails in practice. from material characterization and manufacturing considerations to the nature and duration of patient contact. This episode offers a clear guide on how to build a robust Biological Evaluation Plan (BEP) that can stand up to regulatory scrutiny and ensure patient safety. Consider this scenario. A startup develops a groundbreaking drug-eluting stent but faces a major setback. Their submission is rejected due to an inadequate biocompatibility evaluation. They followed a simple testing checklist but failed to create a comprehensive BEP that assessed the risks of the metal alloy, the polymer coating, and the active drug combined. This oversight leads to a nine-month delay and requires expensive, unplanned long-term studies, jeopardizing their funding and market entry. Key Takeaways: - Why is a risk management process now more critical than a simple testing checklist for ISO 10993-1 compliance? - How do you determine the correct biological endpoints for a device with long-term tissue and blood contact versus one with transient skin contact? - What are the essential components of a Biological Evaluation Plan (BEP) that will satisfy regulators? - When can chemical characterization data be used to reduce the need for extensive animal testing? - What are the most common pitfalls that lead to the rejection of a biocompatibility submission? - How does your manufacturing process impact the biological risk profile of your final device? - For complex devices like combination products, how do you separately evaluate the risks of each component? For more information, contact us at [email protected] or visit https://pureglobal.com/