Design controls are important for ensuring that medical device is safe and effective and meets user ‘s needs and requirement. However FDA design control regulations applies to class III and class II and also some class I devices , every medical device company should follow basic set of design control whether they are making simple deice or a complicated one. Its key elements are design input ,design output, development planning, design verification and validation, DHF. Design control helps to detect and fix the error at an early stage. Properly designed design control helps to improve medical device and prevent issues and problems in device . Design control requires medical device manufacturer to keep documents and records during the development phase to make sure design is safe.