Hi Lamiaa,

If design controls are not adequately used often time the concluding result would be the termination of the project if it’s in early phases or if it’s an approved project this could lead to lower quality product. Design controls ensure all phases in the product development lifecycle will reach an acceptable level of efficacy and safety, while ensuring traceability of processes. The uses of this methodology, if used correctly, increases the probability will reach a level of acceptable quality. Insufficient or inadequate design controls are commonly result in product recalls, FDA warning letters, and CAPA (corrective and preventive actions). I attached a link to article from MED Device online regarding the topic Medical Device Design Controls: Following the Regulation VS. Understand its Intent and it covers the consequences of Insufficient Design controls.

Chris

http://www.meddeviceonline.com/doc/medical-device-design-controls-following-the-regulation-vs-understanding-its-intent-0001