Overview

Effectively managing risk is essential to ensuring the safety, performance, and compliance of medical devices. ISO 14971 outlines the international standard for medical device risk management, and understanding how to apply it is critical for organizations across the industry.

This live-online ISO 14971 training course is certified by Exemplar Global and offers a practical, hands-on approach to implementing risk management using ISO 14971:2019 and ISO/TR 24971:2020. Over two interactive days, participants will explore how to identify hazards, evaluate risk, implement controls, and maintain a comprehensive risk management process throughout the product lifecycle.

Whether you are new to risk management or looking to deepen your expertise, this course is designed to meet you at your current level and build your confidence through expert instruction and real-world case studies.

By the end of the course, participants will be able to:

• Understand the structure and requirements of ISO 14971 and ISO/TR 24971
• Apply risk analysis tools and techniques to medical device scenarios
• Develop and document effective risk management plans
• Integrate risk management into quality systems and design activities
• Monitor, review, and improve risk-related processes over time

Risk isn’t optional, and neither is compliance. This ISO 14971 training gives you more than a theoretical understanding of ISO 14971. It empowers you with practical skills that you can apply immediately in your role to reduce risk, improve product safety, and support regulatory readiness. Whether you’re preparing for audits, contributing to design decisions, or building risk files, this training will help you do it with confidence and credibility.

Prerequisites

There are no required prerequisites for this training.

This ISO 14971 training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students should bring their own printed copy of the ISO 14971:2019 and ISO/TR 24971:2020 standards.

The course provides an overview of these documents, but having your own copy to follow along with will be a powerful learning aid.

Who Should Attend

• Quality Managers
• Engineering Managers
• Audit Program Managers
• Internal and external auditors
• Design Teams
• Management Representatives
• Project Teams
• Anyone who needs to understand the difference between Risk Identification, Risk Assessment, and Risk Management and how to put these important tools to work for your organization

This ISO 14971 training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.