Design controls is a formal methodology to drive medical product development activities, which are often mandatory. Medical device manufacturers must follow design control requirements under 21 CFR Part 820.30 to market all class 2 and 3 devices as well as certain class 1 devices such as software controlled devices. Design control is a set of quality practices and procedures that control the design process to assure that the device meets the user needs, intended uses and specified requirements as well as improve and prevent future issues. On the highest level, design controls requires Medical device design & development planning, design input, design output, design review, design transfer, design changes and design history file.
