Subject: Engr Tech Leadrshp (Grad) (ETLS)

CRN: 41509

Lecture

St Paul: O'Shaughnessy Science Hall 122

  Kristina Simmons, Liz Revnew Wolf, Rita Guzzetta

This class will focus on medical device quality system requirements for medical device manufacturers. The majority of class time will be spent reviewing the U.S. FDA Quality System Regulation with additional focus on the European Quality Standard for Medical Devices, ISO 13485, and the European Medical Device Regulation. The course includes a short overview on the history of FDA regulation, sources of U.S. law and regulated activities. Additional class topics include an introduction to the U.S. regulatory submission process, complaint handling, medical device event reporting, risk management, and corrections & removals. Several classes will include lecture and classroom discussion on how to handle FDA inspections, and the ramification of non-compliance discovered during inspections. Classroom methodology will be lectures with substantial student interaction encouraged. Coursework includes small group presentation and paper development as well as presentations of that work to the broader class.

3 Credits