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  • rd389 replied to the topic Precision and Accuracy in the forum Regulatory Basics for Medical Devices 7 years, 7 months ago

    Accuracy and precision play important role when it comes to FDA and their rules and regulations. I think they main reason they are important is to make sure any medical device is consistent and there is no adverse effect on the patient. Any medical device needs to pass through accuracy and precision or else it cannot pass the validation of that particular device.

    “It’s also a common practice to check the accuracy and precision of laboratory equipment whenever a new instrument is brought into the lab, when equipment is suspected of being damaged, and on a periodic schedule thereafter. In addition, accuracy and precision checks are frequently used as part of the qualification process of a new laboratory technician.”
    Source:
    Defining Accuracy and Precision | Quality Digest. (2017). Qualitydigest.com. Retrieved 2 October 2017, from https://www.qualitydigest.com/inside/fda-compliance-article/defining-accuracy-and-precision.html