In this course you will learn what changes are occurring in regulatory standards, including ISO 10993, Medical Device Regulations, and FDA guidance. Then based on these changes you will learn how to keep your biocompatibility program current.
Using chemical characterization to support biocompatibility of medical devices has become a common occurrence. Not only through increased acceptance, but also through heightened requirements, Chemical Characterization per ISO 10993-18 of a medical device has become an essential component of overall biocompatibility. This talk will present the framework in which we understand and design these programs, illustrate how they are carried out, and close with an overview of how results are used within a toxicological risk assessment per ISO 10993-17.