Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices).

Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework that manufacturers must use when developing and implementing design controls. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.

Source:
Design Control Guidance For Medical Device Manufacturers. (2017). Fda.gov. Retrieved 13 November 2017, from https://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm