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Apr 23, 2024
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MEDDV 102 - Risk Management and Assessment for Medical Devices
3.0 Credits
Overview of principles/techniques to identify/evaluate/control risks associated with development/production of medical devices. Covers risk mgmt plans and reports; risk analysis process; relationship between regulatory requirements and risk mgmt; tools for hazard identification.
Course-level Learning Objectives (CLOs)
Upon successful completion of this course, students will be able to:
- List and explain how each of the elements of FDA QSR 820.30 Design Control relates to risk management.
- Explain the relationship between QSR 820.30 Design Control and the risk management plan.
- Explain the relationship between the product development lifecycle and the risk management plan.
- Explain how risk acceptability is used in risk management.
- Develop a risk management plan for a medical device.
- Perform a risk analysis for a medical device.
- Identify and explain the steps associated with risk control.
- Differentiate residual risk and overall residual risk as it relates to risk management.
- Develop a risk management report.
- Describe the steps used in software risk analysis.
- Explain the relationship between the FDA 21 CFR 820.100 Correction and Preventative Action (CAPA) and post production information.
- List and describe tools and techniques used in successful risk management.
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