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MTQ 624. Risk Management

Credits: 3
Department: Regulatory Affairs
Description: Risk management in the development and use of medical devices. Standards, regulations, methods, and tools for identifying, analyzing, and controlling risks and hazards.
Semester Offered: DEMAND
Grading Method: ABCDF

Student Learning Outcomes

1. Integrate the role of Risk Management in the Medical Device industry
2. Judge medical device hazards and estimate the probability that harm might ocur
3. Assess the severity of harm and evaluate the associated risks
4. Mitigate risks and monitor the effectiveness of the controls put in place
5. Continually evaluate the changes in risk as design evolves and the medical device gets used

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