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  • dsk35 replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago

    In terms of medical devices, accuracy measures how closely certain data fall into the acceptable ranges of operation. If this does not hold true for the device, the device may not perform as intended. Precision requires the device to perform in a similar way consistently so that the same results are produced every time. The FDA requires medical devices to be both accurate and precise so that people using them are effectively getting the drugs/treatment/aid they need.