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Oct 23, 2026
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BMED 2310 - Risk Management and Assessment for Medical Devices
Credits: 3
Catalog Description
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.
Recommended Skills, Abilities, or Coursework: BMED 2300
Additional fee to student: No
Learner Outcomes
- Explain the relationship between product risk management and the Food and Drug Administration (FDA) laws and regulations governing medical devices.
- Illustrate management’s responsibilities associated with risk management.
- Compare and contrast the steps involved in:
- developing a risk management plan
- performing a risk analysis
- completing a risk evaluation
- Discuss how the elements above are integrated in plans designed to control risk.
- Differentiate between determining residual risk and performing an overall risk evaluation.
- Illustrate the relationship between the FDA 21 CFR 820.100 Correction and Preventative Action (CAPA) and post production information monitoring in a medical device manufacturing company.
- Explain the main steps of performing a software risk analysis.
- Describe the tools and techniques used successfully in risk management.
Major Areas of Course Content
- The relationship between product risk management and the Food and Drug Administration (FDA) laws and regulations governing medical device
- Management’s responsibilities associated with risk management
- The main steps in developing a risk management plan
- The main steps in performing a risk analysis
- The main steps in performing risk evaluation
- The process of controlling risk
- The main steps in determining residual risk and performing an overall risk evaluation
- The relationship between the FDA 21 CFR 820.100 Correction and Preventative Action (CAPA) and post production information monitoring
- The main steps of performing a software risk analysis
- The tools and techniques used successfully in risk management
Credit for Prior Learning Options
No credit for prior learning option is available for this course.
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