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  • mem42 replied to the topic What are Design Controls? in the forum Introduction to Design Controls 6 years, 5 months ago

    Design controls have a specific objective and its to assure that the device meets the user needs, intended uses and specified requirements. Design controls also serve as a way to continue improving the device and prevent future problems, FDA callbacks. Most of the callback cases that occur are related to non-conforming materials. The design control of a product must begin right after the design of the device begin and it must stay consistent throughout its development and even when it has been released to the market. By having the consistent design controls we can avoid major issues relating to the user specifications and FDA callbacks.