ISO 14971 Risk Management for Medical Devices Training Event, 28.Apr.2025

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