Indeed, it is important that medical system companies design and develop a medical device that is safe and efficacy for the consumers to use. FDA, IND and other regulatory organizations want to regulate the product and assure that the medical device is safe and efficacy before it is sent into the market. The significance of Design control is that it is the validation of the products for its safe use while meeting all the consumer needs and requirements. As many of you have already mentioned, the requirements of design control initiate with general information, then Designing and developing the plan, input, output, review, verification, validation, transfer, and controlling the design with making changes, and it ends with designing the history file. Most important is keeping the history file, it is vital to keep all design control evidence.