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  • cjm64 replied to the topic Usability Risk Analysis in the forum Risk Analysis for Medical Devices 6 years, 5 months ago

    My research into Task Analysis and Use Error Analysis seems that it is a good way to attempt to mitigate risk that stems from the actual handling and use of the products. IT involves breaking down the function into as many steps as possible and then identifying the risks at each step. This allows for the manufacturer to see exactly where risks might arise. The one major drawback is that no one can truly account for human error. You can design against it as much as you want but humans will find a way to mess it up. For that reasons other risk management strategies need to be employed. The TA-USE strategy should be included as one part of the risk management strategy, but there must be other parts as well.