This course aims to provide participants with a comprehensive understanding of medical device risk management. Throughout the course, topics including risk definition, regulatory requirements, application of standards such as ISO 14971, risk analysis in device design and production, risk management in medical software, and residual risk assessment will be explored in order to ensure the safety and effectiveness of medical devices in the marketplace.

At The End Of The Course You Will Be Able To

• Understand what risk is and its importance in the context of medical devices.
• Become familiar with regulatory requirements related to risk management in medical devices, including ISO 13485:2016, Medical Device Directive (MDR), and FDA – 21 CFR 820.
• Apply the principles of ISO 14971:2019 in medical device risk management.
• Perform a risk analysis and assessment, taking into account intended use and potential misuses.
• Maintain and update the risk management system throughout the lifecycle of the medical device.
• Create and maintain risk management documents.
• Understand risk management in the context of medical device software, including cybersecurity considerations.

Course Content

1. What is Risk and the importance for medical devices
   • Welcome to Course, Presentations and Outline Review
   • Real world RM Case Example
   • Risk Concept Definition
2. Regulatory Requirements for Risk Management
   • ISO 13485:2016
   • Medical Device Directive (MDR)
   • FDA – 21 CFR 820
3. Key Terms and Definitions
4. Overview of ISO 14971:2019
5. General Requirements for Risk Management System
   • Risk Management Process
   • Management responsibilities
   • Personnel
   • Risk Management Plan
6. Risk Analysis and Evaluation
   • Intended Use/Foreseeable misuse
   • Safety Characteristics
   • Hazard and Hazardous Situations
   • Risk Estimation
7. Product and Production Risk Controls
   • Risk Management in Product Design
     • Preliminary Hazard Analysis
     • Hazards Analysis
     • Use FMEA
     • Design FMEA
   • Risk Management in Production
     • Process FMEA
8. Sustaining The Risk Management System
   • Management reporting
   • Production and postproduction activities
     • Production Feedback
     • Post Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)
     • Risk Documents Sustaining and Update
9. Overall Residual Risk
   • Individual and Overall residual risk
10. Benefit-risk analysis
11. Medical device software risk management
    • Software as a medical device
    • Software as a component
    • Software as an accessory
12. Application of ISO 14971 and Software specific standards
    • Basics for software
    • FDA Level of Concern
    • Cybersecurity
    • Risk Reduction