The medical device industry manufacturers a range of technologies and applications, ranging from simple hand-held tools to more complex computer-controlled large surgical machines. While the guidance does not include a set of rigorous implementation methods, it consists of quality system requirements coupled with explanations and relevant design control principles examples. Design control is considered relevant for all devices which can be automated using a software. The purpose of design control for medical devices is to keep patient and user risk low without compromising the integrity of the product manufactured. FDA marked three classes of medical devices, namely Classes I, II, and III, based on product’s use, use indications, and level of risk. This process includes layers of documentation that show the FDA how manufacturers have provided for the new device’s safety and efficacy.
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