Design controls of a medical device covers the design plan, the design itself, the outputs to meet the required design inputs, the design validation and the DHF. It is an important aspect in the design of a new medical device as it ensures that the medical device is capable of performing its intended purpose.
It is a method of controlling and mitigating risk on a medical device. Any deficiencies in the design can be immediately corrected if the design controls are properly implemented.

I believe that the design control process is actually one of the hardest things to implement correctly. Not only does a device manufacturer have to meet the requirements but also extensively test to ensure the device is not defective. This requires a management and corporate culture that is willing to take on these challenges and dispense the necessary resources to do so.