Above, a lot of people listed all the requirements but I wanted to elaborate on one. I think the FDA looks to see that the design changes were implemented. This might seem trivial but its something to look for because people actually overlook this. They might have identified a problem earlier and there is documentation for that. They might have also suggested a solution. The FDA wants to make sure you actually implemented those design changes and updated the system to reflect the current standards. These standards change all the time and they are looking to make sure that recent developments were actually put into the product. A lot of people start a project and they get on one course and they never actually realize that the design control steps never really finish. You are never really done because you have to go back to planning or inputs whenever something happens in industry. This is where a lot of people end up making mistakes and this is what the FDA is looking for in a complete design control system. They are looking to see that you actually went over the design controls a few times and took everything into account.