Design controls are in their simplest form a way to make sure that the product developed and released is going to meet the user needs and also be safe for the user. The process makes sure that those who are using it are doing each step of the design of the product with the necessary amount of checks in place to ensure that the final product they release will be what they set out to make. Design controls will also allow those using them to prove that their product meets whatever requirements of the country or countries they are releasing the product in. They can be used in the event of an issue to prove that the device was designed in such a way that the risks were mitigated and that the issue is not in the design of the device. These documents are a safety protocol of sorts as they make sure that internal development is done in the proper way and can be checked if needed.