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  • nakimw replied to the topic Changing Control in the forum Project Management Process and Medical Device Development 6 years, 1 month ago

    For the company that I work for they implement new devices in order to make the work of technicians easier and ensure quality. One such device is one meant to cut tissue into predetermined shapes with very little human input. The device is not used often however because those who created it did not take into account the size of the room that it is meant to be used in not big enough for the device. In this case, the driving force for the change is the unwillingness of the intended user which is something that I believe is the most important thing because if the person who it is meant for doesn’t want to use it then it is a bad device. To fix it we need to go to change control procedure to either make it smaller or more attractive for the intended user which is a much more abstract concept