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Chris Vasquez replied to the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development 8 years, 2 months ago
I have never personally done a design change from an initial design standpoint, but I have made Engineering Change Orders on documentations post the design change. Essentially these change orders have to be approved by R&D, Quality, and the effected area. Prior to initiating the change order, I would set a meeting with these team groups and address what the change is and how the impact will effect the corresponding teams, and potentially training the applicable people if it is a process change.