Risk Management for Medical Devices – ISO 14971 – Course

Struggling to align your risk management process with European regulations governing medical devices and in vitro diagnostics (MDR/IVDR), as well as US FDA Quality System Regulation (QSR) requirements?

This one-day course gives you the clarity and tools to implement EN ISO 14971:2019 effectively within your quality management system.

You’ll gain a solid understanding of how to identify, evaluate, and control risks throughout the product lifecycle—while ensuring compliance with ISO 13485:2016, MDR/IVDR, and QSR.

Through practical examples and expert guidance, we’ll show you how to integrate risk management with design and development, clinical evaluation, post-market surveillance, and usability engineering. You’ll also learn how to keep your risk management process current through regular reviews and audits.

Learning outcomes

• Confidently interpret risk management requirements under MDR, IVDR, and QSR.
• Define and manage key inputs and outputs of the risk management process.
• Understand the lifecycle approach to risk management and its regulatory implications.
• Integrate risk management into your QMS, audits, and management reviews.

Course content

This course is covering:

Module 1 – Introduction to Risk Management and Regulatory Framework 
Get to grips with ISO 14971 and understand why it’s critical for medical device compliance. Learn the essentials of MDR, IVDR, and QSR and speak the language of risk management with confidence.

Module 2 – Risk Management Planning 
Build a structured, compliant risk management process from the ground up. Define scope, assign responsibilities, and set up documentation that supports every stage of the product lifecycle.

Module 3 – Risk Analysis and Evaluation 
Identify hazards, estimate risks, and decide what’s acceptable. Apply proven methods to assess severity and probability and make informed decisions that meet ISO 14971 standards.

Module 4 – Risk Control and Residual Risk Review 
Implement strong risk controls and measure their impact. Learn how to evaluate residual risk, justify decisions with risk-benefit analysis, and keep everything traceable for reviews.

Module 5 – Risk Management File and Documentation 
Guidance on creating and maintaining the Risk Management File. Follow best practices for documentation, audit readiness, and ensure that all records meet regulatory expectations.

Module 6 – Integration and Compliance 
Connect risk management with Post-Market Surveillance and Quality Management Systems. Embed processes into your QMS and align with MDR, IVDR, and QSR for full compliance.

Target audience

This course is designed for professionals in R&D, production, process development, or quality assurance within the medical device industry
– particularly those who manage, implement, or audit risk management systems.

Prerequisites

• You should have basic knowledge of quality systems (e.g., ISO 13485 principles)
• You should have 1–2 years’ experience in the medical device industry or a similar regulated environment

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