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ajm73 replied to the topic Design Control Process in the forum Introduction to Project Management 6 years, 2 months ago
While I haven’t been part of Design Control process yet as I am new in my current role, I do know that in a few weeks I will be part of a project that will be involved in creating a packaging verification/study for an existing medical device combination kit. This will involve making a change to how the MD is packaged. Because the product itself in terms of the device is not actually changing no design verifiactions are going to have to be done, however, going through the design control is still neccessary for something as “small” as changing how the device is packaged/delivered to the customer. Something small can make a big difference or have a ripple effect down the line and as such even small changes need to be verified to prove that the end product produces the same or better results.