I agree risk management should start at the patient and work backwards to the individual units that themselves can be inputs into an FMEA. When the design gets

I agree risk management should start at the patient and work backwards to the individual units that themselves can be inputs into an FMEA. When the design gets a bit further along, you can perform an FMEA and repeat the process several times over the course of the design. I am always surprised at how many more risks can be identified by doing the process iteratively and frequently. Do you recommend any tools that have helped you perform risk analysis?