ETI 2041 MEDICAL DEVICE DESIGN AND MANUFACTURING 3 credits

Prerequisite: REA 0001. This course will provide an understanding of the processes and procedures using the Food and Drug Administration (FDA) regulation and compliance for the designing and manufacturing of medical devices. Topics include the design process, design tools and management, product and process development, documentation, verification and validation, post market surveillance, and corrective and preventative actions. 47 contact hours.