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  • kdg4 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 8 years, 6 months ago

    FMEA does sound interesting Roberto. By being able to make sure you device fails and then fixing those failures could be a way to have a stronger more reliable product. On the flip side, if you are unable to fix those failures that could be a great indication that this project should be on the market. This seems like something could be useful in risk management. This type of modeling could be helpful in a go or no go meeting.