Design Control Regulations for Medical Device Manufacturers

Manufacturers of medical devices are responsible for ensuring that the products they create follow the rules for design control. This course describes FDA design control regulations by providing basic information about the key procedures followed during the design and development of a product. Topics in this course include: Design and Development Plan, Design Input, Design Output, Design Review, Verification, Validation, Design Transfer, and Change Control. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file, and human factors. After completing this course, learners will be able to recognize the purpose and scope of design control regulations and will also be able to identify the eight main aspects of design control and how they affect medical device manufacturers.

After this course learners will be able to recognize the purpose and scope of design control regulations. identify the eight main aspects of design control and how they affect medical device manufacturers.