Activity

  • mjf34 replied to the topic Discussion Topic: Verification vs. Validation in the forum The Design History File 8 years, 2 months ago

    Verification is making sure that the product/ device is functional and performs as it should. It entails testing, inspections, and analysis. Validation is making sure that the product/device is useful and meets the needs of a consumer. It ensures that the product or device has a market and a purpose for existing.

    V&V overlap for both the device and the process in that they both have a similar end goal: to make a functional product that will meet the needs of a consumer while following governmental and company guidelines.
    From my understanding, verification for a device means that the device must meet the requirements as stated by the FDA or other governing council. Verification for a process ensures that SOP’s and other company guidelines are followed.
    Validation for a device ensures that the product addresses a consumer or stakeholder’s need. Validation for a process ensures that a device’s manufacture methods are practical and efficient (both in time and money) for the device being made.

    -Michelle F