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  • dh239 replied to the topic Usability Risk Analysis in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    I believe that thorough documentation of failures and tests with attention to a variety of components would be the best way to analyze risk. Often times, failures due to one cause can indicate weaknesses in different parts of the design. By monitoring the reason for failure along with other aspects of the design, it is possible o improve the product holistically and make it safe for use.