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  • pt58 replied to the topic Usability Risk Analysis in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    I think it is important to look at risk from several different methods. My company uses a Risk Management Summary, Failure mode, effects and criticality analysis, Process Failure Mode Effects Analysis, and Design Failure Mode and Effect Analysis for our products. A combined view of all these quality system documents really help most engineers wrap their heads around what the main issue is and how it can be mitigated. Critical analysis examines potential product/service features against a list of critical factors, evaluates feature priorities, and helps determine what organization or internal function is responsible for the critical factors.