When should design controls end?….design controls never end. As long as device manufacturers have devices in development, in production or in the field, design controls should be followed. Device manufacturers may think that design controls are only used during the development phase when in reality they should be continued to be used even after implemented into the production environment. When the design or manufacturing process is changed or when problems occur in the field that drive a change, many elements of the design control process should be used to address the change or evaluate risk. Or in other words, design controls should be cracked back open to determine if the device should be changed and to determine the necessary design elements that must take place to modify the device such as verification, validation, update inputs & outputs, or update the design history file, etc.