Course Description
This 5-day course provides comprehensive training on ISO 14971:2019 for medical device risk management. Participants will learn to apply risk management principles throughout the product lifecycle, from design to post-market surveillance. The course covers risk analysis techniques, evaluation methods, control measures, and regulatory compliance.
Learning Objectives
- Understand the principles and requirements of ISO 14971:2019
- Apply risk management techniques throughout the medical device lifecycle
- Develop effective risk analysis, evaluation, and control strategies
- Implement a compliant risk management process within a quality management system
- Integrate risk management with design controls and post-market surveillance
Course Modules
Day 1: Introduction to Risk Management
- Overview of ISO 14971:2019
- Risk management principles and terminology
- Regulatory requirements and standards
- Risk management process and lifecycle approach
Day 2: Risk Analysis Techniques
- Hazard identification methods
- Fault Tree Analysis (FTA)
- Failure Mode and Effects Analysis (FMEA)
- Preliminary Hazard Analysis (PHA)
Day 3: Risk Evaluation and Control
- Risk estimation and evaluation techniques
- Risk control option analysis
- Residual risk evaluation
- Benefit-risk analysis
Day 4: Risk Management Implementation
- Developing a risk management plan
- Integration with design controls
- Risk management file documentation
- Traceability in risk management
Day 5: Production and Post-Production
- Risk monitoring and review
- Post-market surveillance integration
- Risk management reporting
- Continuous improvement of the risk management process
Practical Wins for Participants
- Ability to implement a compliant risk management process
- Skills to perform comprehensive risk analysis and evaluation
- Knowledge to integrate risk management with other quality processes
- Confidence in addressing regulatory requirements for risk management
Credits: 5 credit per day
Course Mode: full-time
Provider: Blackbird Training Centre
