Starting with a biocompatible material is crucial for medical device manufacturers. However, regulatory requirements are pushing manufacturers to seek more information and support from their suppliers. Biocompatibility of materials is critical to staying competitive and providing clients with the necessary information to ensure the safety and efficacy of their products.
This webinar will cover several key topics, including an overview of ISO 10993-1, which provides guidance on the biological evaluation of medical devices. We will also discuss the MDR regulation concerning carcinogens, mutagens, and reproductive toxins (CMRs) for raw materials. Understanding where the responsibility lies between the material supplier and the device manufacturer is essential to ensure compliance and avoid regulatory pitfalls. The presentation will explore what information and testing on raw materials are useful for determining the biocompatibility of the final device. Attendees will gain insights into the specific requirements for materials used in medical devices, the types of testing required, and how to interpret test results.
By the end of this session, viewers will be equipped with the knowledge to select biocompatible materials, conduct appropriate testing, and maintain compliance with regulatory requirements, ensuring the safety and effectiveness of their medical devices.