Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not cause adverse biological reactions when in contact with the human body. This presentation focuses on applying the new ISO 10993 standards, which provide comprehensive guidelines for evaluating the biocompatibility of medical devices. The ISO 10993 series has been updated to reflect advancements in science and technology, incorporating new testing methodologies and risk assessment approaches.
Viewers will gain a thorough understanding of the key changes in the standards, including the expanded requirements for chemical characterization, in vitro and in vivo testing, and toxicological risk assessment. The presentation will provide practical guidance on how to implement these new standards in a medical device development program, from initial material selection through to final product testing. Case studies will illustrate successful applications of the standards, highlighting common challenges and solutions. By the end of this session, participants will be equipped with the knowledge to conduct comprehensive biocompatibility evaluations, ensuring their devices meet regulatory requirements and maintain high safety and performance standards. This understanding is essential for navigating the complex regulatory landscape and achieving successful market entry for new medical devices.