A hybrid Bayesian network for medical device risk assessment and management. (arXiv:2209.03352v1 [cs.LG])

ISO 14971 is the primary standard used for medical device risk management.
While it specifies the requirements for medical device risk management, it does
not specify a particular method for performing risk management. Hence, medical
device manufacturers are free to develop or use any appropriate methods for
managing the risk of medical devices. The most commonly used methods, such as
Fault Tree Analysis (FTA), are unable to provide a reasonable basis for
computing risk estimates when there are limited or …

arxiv bayesian hybrid management medical medical device network risk risk assessment