I agree. From what I have seen in the medical industry, when a design change is necessary the steps taken depends on the stage of the project. Currently, I am working on a project that hasn’t completed it’s clinical trials yet, meaning it completed the regulatory submission necessary to launch to product. A change in the design was necessary during the verification stage of the project. A written justification for the change was required for the Summative reliability studies, which will be a part of the regulatory submissions for the FDA, Health Canada, and CE-mark approvals. When there is a design change for products that are already launched into the market, we have to complete an engineering change request (ECR) and an engineering change order (ECO). Since we are the legal manufacturer, the request is written and completed from the R&D/Software team while the ECO is written and completed from the Operations team as well as any suppliers that are involved in this change. Documentation, such as the project quality plan (PQP) or risk management reports, is then updated to accommodate this change.