The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry. Through hands-on activities and case studies, students will gain valuable experience in real-life risk situations.

At The End Of The Course You Will Be Able To

• Understand the notion of risk and its relevance in the context of the medical devices industry.
• Become familiar with the legal and regulatory requirements related to risk management in the medical field.
• Learn the key terms and definitions related to risk management, establishing a solid knowledge base.
• Explore the principles and guidelines of ISO 14971:2019, which is used for risk management in medical devices.
• Learn about common tools used to control and mitigate risks associated with products and production processes.
• Learn how to effectively maintain and update risk documentation to ensure it is current and accurately reflects the current situation.
• Understand how to assess and manage residual risk in a global context, taking into account all factors involved in medical devices risk management.

Course Content

1. What is Risk and the importance for medical
   • 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. Typical Product and Production Risk Control Tools
   • Risk Management in Product Design
     • Preliminary Hazard Analysis
     • Hazards Analysis
     • Use FMEA
     • Design FMEA
   • Risk Management in Production
     • Process FMEA
6. Risk Documents Sustaining and Update
   • Production and postproduction activities
     • Production Feedback
     • Post Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)
     • Risk Documents Sustaining and Update
7. Overall Residual Risk
   • Individual and Overall residual risk