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  • dsk35 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 6 years, 4 months ago

    One technique for risk analysis that I came across is a bottom-up approach called HAZOP (Hazard and operability). This is usually used for more complex devices that has a very involved process. In this instance, multiple control factors are identified and evaluated using a risk matrix. Another approach is FTA (fault tree analysis), which is a top-down approach where unwanted consequences or results are discussed and any contributing factor is identified. Then those factors are categorized into logic gates, where if two events combined, it would result in another larger scale event.