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  • jz365 replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices 6 years, 10 months ago

    The type of risk plays a role in what statistical analysis you need when testing. Most companies here just use a higher sample size when testing high risk hazards but I believe it can go deeper than that. Each risk has an associate frequency and severity. For high frequency risks, increasing the sample size does not seem to make as much logical sense as increasing the power of the test. If you know the risk frequently happens, increasing the sample size will not change the proportion of failures. Decreasing the standard deviation is the way to go. For high severity risks, increasing the sample size makes sense. For very severe risks, it makes more sense to make sure it never happens, rather than trying to lessen the effect of it happening.