Issues with design controls:
· assessing new product ideas
· training and retraining of design managers and design staff
· use of consultants
· evaluation of the design process
· product evaluation, including third party product certification and approvals
· patenting or other means of design protection

Source:
(2017). Fda.gov. Retrieved 13 November 2017, from https://www.fda.gov/downloads/MedicalDevices/…/ucm070642.pdf