Typically within the medical device company I work in, design changes are generally driven through an engineering change request. These ECRs generally have five phases where phase one is when the overall scope of the change in encompassed with the proposal as well. The submitter of the change drives the ECR and drafts the first phase and is considered the project manager of the change. Then the following phase, the PM pulls together a broader team to understand the impact from a regulatory, manufacturing, R&D, supplier and other facets of the design perspective. If there are any impacts to any of these groups, they will define deliverables that need to be completed prior to the release of the design change. Generally there are lots of approvals and discussions that go into phase 2 prior to presenting the change to the engineering design board but all facets of the medical device can be covered through this. The third phase is where the design change is presented to a board of experts which of whom will accept or deny the request. If approved, the redlines within a drawing where most designs are shown are then able to updated here in a pre-released state. All deliverables stated in phase four will also be collected here. Phase 5 is where everything is reviewed by ECR head and approved for closure. At this point the ECR is considered closed and the design change has been approved for release.