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  • Like many of you have said, verification is key to a successful device that will benefit the end users. However, carrying through with this process is imperative to the success and potential risks a company is taking when producing a device. Like Dr. Simon had mentioned, if verification is not done properly, it could lead to issues with the FDA.

    The earlier this process is done, the better. Verification checks to see if the prototype does what it was designed to do. If not, then the company is not fulfilling the requirements set by the customer. Ensuring that the device meets the input and outputs through reviewing the DID acts like a once over before sending it out for production.

    One thing that can improve the efficiency of this process is coming up with a verification protocol early on in the developmental processes. Once all the primary design documents are completed and testing has commenced, one can get carried away with the developmental process of the device and lose track of the initial inputs and outputs put in. Therefore, I propose that a verification protocol should be made up as soon as possible with all the inputs and outputs set out preventing any set-backs that would delay the release of the device.