Evaluating and Testing within a Risk Management Process, is the most widely used standard for assessing the biocompatibility of medical devices and materials, and provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Specific testing is dependent on the type of medical device or material and its intended use, and on the duration of contact between the medical device and the human body. Updates and modifications to available guidance for biological safety testing of medical devices, as described by the International Organization for Standardization (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and decreased the level of harmonization in testing requirements. However, the new ISO standard 10993-1 under development and new finalized guidance from the FDA show a similar approach – which is a shift away from routine testing-based approaches to much greater emphasis on chemical characterization. This presentation will explain the upcoming changes and their influence on the testing strategy in the future.
As Head of Eurofins Professional Consulting Services Munich, Dr. Hofman-Hüther, has gained more than 15 years’ experience in toxicology, genotoxicity, and biological safety assessment. Her background includes extensive demonstrated expertise in the medical device industry in the areas of quality assurance & regulatory affairs with a specialty in biocompatibility, toxicity, and toxicological risk assessments. She is a toxicologist and an active member at DIN /ISO, IVTIP, GUM, DGPT, EEMS, NETVAL, and she accompanied numerous audits according to GLP, GMP, DIN EN ISO 17025 and FDA.