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ISO 14971:2019 Risk Management for Medical Devices

ISO 14971:2019 TRAINING COURSE INFORMATION

£129
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This online course is designed for professionals involved in medical device development, manufacturing, or regulation. It focuses on the real-world application of ISO 14971:2019, helping learners understand how effective risk management ensures device safety, performance, and regulatory compliance.

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Not Enrolled

Price

£129.00

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KEY FEATURES OF OUR ONLINEISO 14971:2019 TRAINING COURSE:

  • 100% online and accessible anytime, anywhere
  • Developed by experts with 35+ years of experience in clinical research
  • Enhanced with interactive content and robust knowledge checks
  • Certification on completion

Developed by industry experts, the course provides clear, practical guidance on identifying hazards, analysing and evaluating risks, implementing controls, and monitoring safety throughout the product lifecycle. It also covers key concepts such as residual risk, benefit–risk assessment, and integration with quality management systems like ISO 13485.

With a structured, user-friendly approach, the course equips learners with the knowledge and confidence to apply ISO 14971:2019 effectively in practice.

Course Content

ISO 14971:2019 Risk Management for Medical Devices

Course Support

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WHAT WILL I LEARN FROM THIS ISO 14971:2019 TRAINING COURSE?

Explain the key principles and process of risk management under ISO 14971:2019.

Identify hazards, estimate and evaluate risks, and determine appropriate risk control measures throughout the medical device lifecycle.

Apply residual risk and benefit–risk analysis principles to support safe and effective medical device development.

Explain how ISO 14971 risk management integrates with ISO 13485 quality management systems and ongoing production and post-production monitoring.

FAQs

Why should I choose this online ISO 14971:2019 training course?

Our online ISO 14971:2019 Risk Management for Medical Devices training course has been developed to provide practical, industry-relevant knowledge of the medical device risk management process. This self-paced course covers hazard identification, risk evaluation, risk controls, residual risk, benefit–risk analysis and ongoing monitoring, while showing how risk management integrates with quality management systems and regulatory compliance. You’ll gain the knowledge and confidence to apply ISO 14971 principles throughout the medical device lifecycle.

Can I buy this course for my team?

Yes. We offer team licences for organisations of all sizes, making it easy to enrol multiple learners, track their progress and manage training in one place. Please contact us to discuss your requirements and receive a tailored quotation.

Do I need any previous clinical research experience?

No. This course is suitable for learners with little or no previous clinical research experience, as well as professionals looking to refresh or expand their knowledge. The content is presented in a clear, practical way, making it accessible to a wide range of learners.

What makes this course different?

Our training isn’t just a tick-box exercise. Every course is written by experienced clinical research professionals, not AI, and is designed to be engaging, interactive and relevant to real-world practice. Through realistic scenarios, knowledge checks and practical examples, you’ll build confidence in applying what you’ve learned, not just remembering it.

If this course isn’t right for you, take a look at our other online clinical courses.