All medical devices that are intended to contact patients or medical personnel (directly or indirectly) require an evaluation of their biocompatibility prior to regulatory submission and market release. The umbrella document for this evaluation is the international standard ISO 10993-1, which includes the framework and thought process for the biological evaluation of medical devices.
The potential risks that medical devices carry depend highly on their intended contact type and cumulative duration of use. However, before jumping into testing for the specified biological endpoints identified by Table A.1 in ISO 10993-1, one should consider available information that could provide evidence in support of biological safety and reduce the need for testing. This so-called “risk-based approach” is the heart of the standard and should be applied to any medical device, whether it is being newly submitted for market release or undergoing changes.
The session will cover the critical aspects of developing a BEP, including identifying relevant biological endpoints, assessing existing data, and determining the necessity and scope of additional testing. By understanding and implementing a risk-based approach, professionals involved in medical device development, regulatory affairs, and quality assurance can enhance the safety and efficacy of their products, ensuring compliance with ISO 10993-1 and other relevant standards.
Whether you are preparing a new medical device for market release or managing changes to an existing device, this presentation will equip you with the knowledge and tools needed to ensure biological safety and regulatory compliance.