University of Minnesota
Software Engineering Center

You are here

Safety assurance cases: What the medical device industry is doing

Since the FDA began requiring safety assurance cases in submissions for infusion pumps, and suggested that they may be part of guidance for other types of devices in the future, parts of the medical device industry have begun to learn about safety assurance cases in some detail. This talk will discuss what the medical device industry is learning and plans to create guidance and training on safety assurance cases by and for the medical device industry.