For medical devices there is an ISO standard which is ISO 14971. ISO 14971 is the Application of Risk Management to medical devices. In general, it states the specification for manufacturers to identify the hazards associated with medical devices, including in vitro diagnostic medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The five steps of Risk Management for Medical Devices given by FDA and/or ISO. Also, Dr.Simon spoke on these briefly as well.
1) Risk Management Framework & Planning
2) Risk Analysis
3) Risk Evaluation
4) Risk Control
5) Reports and Documents
What I find interesting is the Risk Evaluation matrix. A matrix of severity versus occurrence can be used to establish risk. The concept is simple but the effect of visually seeing it helps me to realize if something is high severity vs low occurrence vs high severity and high occurrence.