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  • ak977 replied to the topic Design validation in the forum Project Management Process and Medical Device Development 7 years, 1 month ago

    Design Verification entails that the product you put out is what was actually requested and what the FDA has said is acceptable.
    Let’s say that the customer wants a product that addresses issues A, B, C, and D. In addition, the FDA says that it MUST align with Rules 1, 2, and 3. Then, when you create the product but miss issue B and rule 2 because you didn’t utilise Design Verification, that will not only leave you with a dissatisfied customer and a product that won’t be allowed on the market, it will have meant that you’ve lost out on millions of dollars and hundreds of hours of work, depending on what the product is.
    Therefore, its always best to employ this step.