Design controls are required to:
1. Deliver the intended use and functionality
2. Ensure safety and reliability
3. Ensure human factors pertaining to design control are considered and addressed in the final design of the device
Failure to meet the above criteria would mean that the device has not met the sufficient design control requirements. Some of the consequences would be: software glitches in the device if it is operated using a GUI, compromising safety of the patient while handling the device and in some cases unintended mishandling of the device due to insufficient conformance to device specifications.