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Anthony Monaco replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 8 years ago
There are many places within design control that can result in failure. This can either be in the early development stages of development or all the way at the end when the product is communicated with the public and released. In the early stages, a major error can be made when not listing all of the necessary design inputs. Especially in the medical device industry, if a safety constraint is forgotten, it can lead to a very difficult problem to fix in the future. In the middle of the process, redesign is very important of well. This is where the company should be refining the product because of any problems found during initial testing. Towards the end of the design process, if the creators of the product do not communicate the product correctly, it can also result in problems. As we learned earlier, they cannot state the product can do something without proof to back it up. Without this proof, with product with not sell as intended.