Regulation of Medical Devices
1.0
creditsAverage Course Rating
This course introduces graduate students in Bioengineering Innovation and Design to the medical device regulatory framework, as it pertains to bringing a medical device from concept to market. Topics covered include; FDA Design Controls; Regulatory Approval mechanisms, including the 510k and PMA process; Investigational Device exemption (IDE); planning clinical trials needed for bringing a medical device to market; and postmarket surveillance. Students learn from a series of invited lecturers from the FDA as well as professionals from the medical device industry. This summer course is required for CBID masters students and is not open to any other students.