Safety is a key factor when designing and developing a medical device. Regulatory bodies, such as the FDA, wants assurance that the medical device is safe before bringing the product to the market. Thus, the essence of Design Controls is proof that a company designed a safe product that meets user needs and requirements. Design verification, DHF, design validation, and design inputs and outputs, all create traits of design controls. Effective design controls prevents against product-liability claims, such as design defect. According to the customer who files a design-defect claim, there is a safer design that exists for the product. However, Design Controls can be used by the company to demonstrate that the risks associated with other designs were considered and that the safest design for the product is currently being used. It has important advantages for regulatory compliance, products-liability avoidance, and assures the most efficacious product design.