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  • dfn3 replied to the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls 6 years, 10 months ago

    I am currently in Capstone 1 at NJIT. The business requirements document is very important because it is takes the customer needs given to us and puts us on a path to create a product. I do believe that all medical devices do go through these steps because it is a great way to make the best product. But almost every time the best product is not made because products can always be improved especially if technology is growing. By using the documents we can keep in order the customer needs and all the specifications of each product which in the long run can help when improving the product. So as tedious as these documents and the process as a whole are it can be very helpful down the road.