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kmt29 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls 8 years, 7 months ago
At first before reading the other comments I thought that design control was needed in the EU, but I saw that it is not mandated unlike the US. The pros in a DHF are that allows you to see the growth and changes within the design process each step meaning the changes that may occur for at any instant; for example what if the raw material may need to change, because they found it a better option. Unlike EU you wouldn’t pay it any mind that the raw material changed, because you are only focused overall development, not the small details. Which are the most important in my opinion they can make or break a product?