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  • wms7 replied to the topic Design Change Request in the forum Project Management Process and Medical Device Development 7 years, 3 months ago

    For my company, to initiate a design change request, the CAD model and drawings must be updated with any changes that are being proposed. It is then reviewed and hopefully approved. If approved, our PM team creates a change request document that will list all the changes done and all product SKUs that will be affected by this change, they will also communicate these changes to the vendor. This document will be submitted to our Engineering Change Control & NPI team, for them to put into our product database. Once they process it and it’s our product database, the redesign change is complete.