Risk Management
General
Prefix
MTQ
Course Number
624
Course Level
Graduate
Instruction Mode
Lecture
Department/Unit(s)
College/School
College of Science and Engineering
Description
Risk management in the development and use of medical devices. Standards, regulations, methods, and tools for identifying, analyzing, and controlling risks and hazards.
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Integrate the role of Risk Management in the Medical Device industry
Outcome
Judge medical device hazards and estimate the probability that harm might ocur
Outcome
Assess the severity of harm and evaluate the associated risks
Outcome
Mitigate risks and monitor the effectiveness of the controls put in place
Outcome
Continually evaluate the changes in risk as design evolves and the medical device gets used