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 management plans and reports; risk analysis process; relationship between regulatory requirements and risk management; 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. [COMMUNICATE]
Explain the relationship between QSR 820.30 Design Control and the risk management plan. [COMMUNICATE]
Explain the relationship between the product development lifecycle and the risk management plan. [COMMUNICATE]
Explain how risk acceptability is used in risk management. [COMMUNICATE]
Develop a risk management plan for a medical device. [REASON]
Perform a risk analysis for a medical device. [REASON]
Identify and explain the steps associated with risk control. [COMMUNICATE]
Differentiate residual risk and overall residual risk as it relates to risk management. [REASON]
Develop a risk management report. [COMMUNICATE]
Describe the steps used in software risk analysis. [COMMUNICATE]
Explain the relationship between the FDA 21 CFR 820.100 Correction and Preventative Action (CAPA) and post production information. [COMMUNICATE]
List and describe tools and techniques used in successful risk management. [COMMUNICATE]