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hi this is Rob Packard from medical device Academy and this is a short video explaining what you get when you purchase sys006 our Change Control procedure this is separate from our design control procedure we felt it made a lot of sense to keep it separate from the design control procedure because its something that you only perform after youve approved the design of your product not something that you do during the design of the product the level of control that you want for something thats already been cleared by the FDA or its already been C marked is quite different from the level of control that you want to put on a product during the design process you want less control so you can make faster changes in the middle of a design project and you want very tight controls that make sure that youve done the regular necessary regulatory submissions and unnecessary revalidation before you release a design change so let me share my screen here now this is the SOP for sales folder that