DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS

The medical device industry encompasses a wide range of technologies and applications, ranging from simple hand tools to complex computer-controlled surgical machines, from implantable screws to artificial organs, from blood-glucose test strips to diagnostic imaging systems and laboratory test equipment. These devices are manufactured by companies varying in size and structure, methods of design and development, and methods of management. These factors significantly influence how design controls are actually applied. Given this diversity, this guidance does not suggest particular methods of implementation, and therefore, must not be used to assess compliance with the quality system requirements. Rather, the intent is to expand upon the distilled language of the quality system requirements with practical explanations and examples of design control principles. Armed with this basic knowledge, manufacturers can and should seek out technology-specific guidance on applying design controls to their particular situation.