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  • Dkonara921 replied to the topic What are Design Controls? in the forum Introduction to Design Controls 6 years, 11 months ago

    A good way to think about Design Controls is that it is a systematic approach that is used for one main purpose: to ensure that a developed complies with the imposed regulations. It describes the entire process in which a concept or idea is brought into fruition by developing a tangible product that complies with certain rules and limitations. The order of the steps in Design Control is pretty straightforward and it makes sense logically why each step is placed the way it is in the sequence. In my opinion, the most important thing that must be applied in any part of the medical device development process is documentation. Documenting all of the major activities is extremely important because this can help avoid legal liability and can help expedite the process. Furthermore, it can prevent mistakes going forward because the more documents you make, the more you have to refer back to you if you need help moving forward in the process.