Health / Medical Topics

    Device Material and Chemistry Evaluation Method

    Testing devices for malfunctions that arise from problems with its components or materials or how its materials or components react to other elements either within the device or within the environment. (Food and Drug Administration)




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    Performing a review of the manufacturing steps and processes to ensure that they were met and followed and that the device records…
    Problems with a device that can be traced back to a problem in the manufacturing and/or production process.
    The device problem was traced back to the manufacture of the device as opposed to systems used to control the manufacture of…
    The date (and time) on which the medical device is made.
    A coded value specifying the defect or malfunction that occurred during use of the device.
    Performing a review the technical and corresponding administrative actions and records intended to retain an item in, or restore it to, a…

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