Design controls are necessary documentations required by the FDA to ensure that a product is in compliance with regulations, is safe and meets customer needs. In 1984, FDA identified lack of design controls as one of the major causes of device recalls. Having good design controls during product development stage decreases the chances that the product will be recalled from the market and prevents the company from losing money associated with that particular recall. Some elements included in design controls are design inputs, outputs, verifications, reviews and validations. Some of these elements are pretty similar to what we did in our capstone class where we wrote product requirements documents depending on customers’ needs and test plans that we later used to test if the product we developed throughout the course meets those requirements.