I also work for a medical device company and I agree with the concerns above. I would also add a challenge that we face with design control quality is that they constantly make up new rules for us to follow as per their ‘style’ of doing things or how they want it done. Sometime they mandate that things are done a certain way in the design change package that is not required in our procedures. It sounds small but often times, it causes us to redo work and delay project timelines.

For example, I was working on a project where I had to obsolete some part numbers. Typically we would just add quick report printout from our data management system into the design change package. For this project, QA began making us assess the report printout in our Design Output Assessments and would not approve any changes unless things were done this way. Weeks went by and management eventually convinced quality that this report printout is not a design output and is not appropriate in the assessment.