Health / Medical Topics

    Device Design Validation Evaluation Method

    Validating that the device meets the user's needs and intended uses. (Food and Drug Administration)




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    The device or component had faulty (incomplete or incorrect) software design.
    The device problem was traced back to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy).
    A device designed to install something or distribute something in a systematic way.
    Device problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and…
    Testing the device for its corrosive behavior to specific environments or materials. Tests may include polarization, potentiostatic, galvanic, critical pitting/crevice temperature, and…
    Device problems caused by changes in the shape or size of the device or device component due to an applied force. This…

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