The chemical and physical characterization of materials and devices has long been considered an important step in evaluating biological safety. The most recent revisions of ISO 10993-1:2018 and ISO 10993-18:2020 continue to emphasize the importance of this evaluation and potential testing needs.

Medical device risk management is not optional – it is a regulatory requirement worldwide. But with today’s medical device regulatory environment changing faster than ever, and the confusion that can come with Risk Management, it doesn’t mean it’s easy. The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives understand and implement risk management concepts that can help meet FDA, ISO 14971, ISO 13485:2016, and the MDR 2017/745 requirements for risk management.