while many have mentioned FMECA as the main tool for identifying risk, I believe during the brainstorming process identifying risks, priority should be placed on the risk of the most critical parts of the device that cannot be avoided, followed by the risk on that can be mitigated or transferred, then lastly risks that can be accepted. this same procedure should be taken with level of parts with decreasing criticality until the entire device has been reviewed. by prioritizing types of risks during brainstorming, the risk identification process should require less rounds of analysis to properly document and address all risks involved.