ETI 2031 RISK MANAGMENT AND ASSESSMENT FOR MEDICAL DEVICES 3 credits

Prerequisite: REA 0001. This course provides the students with an in-depth understanding of the principles and techniques of identifying, evaluating, and controlling risks associated with the development and production of medical devices. This course will cover risk management planning, risk analysis process, and risk management reporting. Topics will include the relationship between regulatory requirements and risk management, tools for hazard identification, methods for the mitigation of risks, and approaches for analyzing risk verses benefit. 47 contact hours.