Build a Risk Management System That Extends Beyond Design

Learn how to apply risk management across the entire medical device lifecycle using the principles of ISO 14971 and the expectations of QMSR. This practical course explains how to identify hazards, evaluate risk, implement effective controls, and maintain a living risk management process long after a product reaches the market.

What's Included

• 4 structured training modules
• Practical guidance aligned with ISO 14971 and QMSR expectations
• Risk analysis, estimation, evaluation, and control methodologies
• FMEA, Fault Tree Analysis, FRACAS, and other risk management tools
• Human factors and usability engineering integration
• Post-market surveillance and risk file maintenance strategies
• Quiz and certificate of completion
• 1 year of access

Price: $215 USD

After Purchase

Immediately after purchase you will:

• Receive access to the course platform
• Begin with Lesson 1: Risk Introductions and Regulatory Context
• Progress through the lessons at your own pace
• Complete the quiz and receive your certificate

Secure your access and start strengthening your risk management program today.