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  • Yiming Cheng replied to the topic Design Verification & Validation in the forum Introduction to Design Controls 9 years, 1 month ago

    According to FDA,

    820.30(f) Design verification shall confirm that the design outputs meets the design inputs requirements.

    820.30(g) Design validation shall be performed under defined operating conditions on initial production units, lots or batches, or their equivalents. Design validation shall ensure that devices conform to intended uses, including the needs of the user and patient, and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate.

    Addition to all above,
    Design verification is all of the inspection, measurement, analysis, or testing that proves that one has the correct output specifications relative to the design input requirements. Design verification is less about testing and more about ensuring that as one moves from the initial design input requirements and subsequently translate them to more refined requirements.

    Design validation, however, proves that with the final design output specifications, the design (finished, packaged, and labeled device) will perform as intended and as users need.

    -Yiming