As we all learned in risk management, Failure Modes and Effects Analysis (FMEA) and fault tree analysis (FTA) is a valuable tool used to evaluate errors in medical device designs. In my opinion if risk analysis evaluated earlier there is a chance where potential errors can be corrected or they can identify it later so they can correct the flaws or errors. These two are the best method in risk management.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/ucm119190.htm