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  • kak33 replied to the topic Does your company use ECOs? in the forum Device Documentation 7 years, 2 months ago

    I currently work as a manufacturing engineer at a medical device company. My team is responsible for maintaining the on market device. We use DCPs (Design Change Process) to make any changes to the device, including labeling. People who join our team from other companies really thing that our process is more tedious and elaborate. Recently the president of our division suggested that the business review the process to stream line some activities. Similarly, we have to propose our changes to a change control board (CCB). Once a change has been opened, you must conduct a risk analysis, an initial design review to discuss the verification strategy and any impact to associate Design inputs, conduct verification activities, assess process validation impact, and execute design change activities.
    Personally, I can see SOME areas for improvement to streamline the process. But I think a lot of the activities are not overhead but are necessary for traceability and helps us meet thorough expectations of the FDA.