In adoption of the concepts of ICH Q8/Q9, the control strategy can be established for the medical device during Design Transfer by the manufacturing engineer. As an outcome, the control plan is like a recipe for manufacturing on how to test what, when, and with how many samples. It is within the control plan where all the incoming inspections, in-process controls (IPC) and lot release tests are listed and justified.
The control strategy, and specifically the control plan, is the core document for manufacturing.