According to the ICH Q9 Guidance, the risk assessment decision tree is the same in medical devices and pharma. Interestingly, in addition to the FMECA as mentioned in the lectures the Fault Tree Analysis is used as a risk management tool. The FTA tool (see IEC 61025) is an approach that assumes failure of the functionality of a product or process. This tool evaluates system (or subsystem) failures one at a time but can combine multiple causes of failure by identifying causal chains.