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Understanding and Applying ISO 14971 Risk Management
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Understanding and Applying ISO 14971 Risk Management

8 & 9 September 2026 | 2-Day Live Online Course

Original price was: €705.Current price is: €564.

2-day Live Online Training 

Gain the knowledge and practical tools to implement ISO 14971:2019 and integrate risk management across your device lifecycle.

 

Register Early to Save

 

Enrol before 14 August to save 20% (Sep Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

ISO 14971:2019 is the cornerstone standard for risk management in medical devices and IVDs. It sets out the principles and processes manufacturers must follow to identify hazards, estimate and evaluate risks, control them, and monitor their effectiveness throughout the product lifecycle.

 

This course provides a practical overview of ISO 14971, its regulatory context under EU MDR/IVDR and FDA expectations, and how it integrates with ISO 13485 QMS requirements. Through examples and tools such as FMEA and fault tree analysis, participants will learn how to apply risk management in practice and prepare compliant documentation.

 

Learn more about how we deliver live online training.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

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Key Learning Objectives

 

  • Understand the scope, structure, and terminology of ISO 14971:2019
  • Recognise the role of risk management within EU MDR/IVDR and ISO 13485:2016
  • Apply risk management to product design, development, and lifecycle activities
  • Use practical risk management tools (e.g. FMEA, HACCP, fault tree analysis)
  • Link usability engineering, post-market surveillance, and clinical evidence to risk management
  • Prepare and maintain risk management documentation (plans, reports, files)

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

8 & 9 September 2026

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

 

Course Outline

Course Information

  • The course begins at the time stated below
  • The course is broken up into modules outlined below
  • There will be breaks between modules

8 & 9 September 2026

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

Session 1 | Day 1

210 mins | 1:00 PM UK

Introduction to Risk Management in Medical Devices

  • Role of risk management in device safety and performance
  • Regulatory context: MDR, IVDR, and FDA expectations
  • Links with ISO 13485:2016

 

Overview of ISO 14971:2019

  • Structure, scope, and definitions
  • Risk management planning: top-down and bottom-up approaches
  • Risk evaluation, control, and mitigation strategies
  • Creating and maintaining a Risk Management File & Report

 

Practical Application – Core Tools

  • FMEA (Failure Modes and Effects Analysis)
  • Fault Tree Analysis and SWIFT
  • HACCP and qualitative severity scoring
Session 2 | Day 2

210 mins | 1:00 PM UK

Risk Management in Design & Usability

  • Integration with design controls and product development
  • Usability engineering and EN ISO 62366: human factors and user interfaces
  • Validation of alarms, warnings, and Instructions for Use (IFUs)

 

Integrated Risk Management

  • How risk management links to QMS processes (ISO 13485)
  • Risk in post-market surveillance, vigilance, and clinical evaluation
  • Using feedback and real-world data to update risk assessments

 

Linkages with Other Standards

  • Biological evaluation (ISO 10993-1)
  • Electrical safety (IEC 60601)
  • Sterilisation, packaging, and cleanroom standards (ISO 11135, ISO 14644)

 

Wrap-Up and Discussion

  • Case examples of risk management in practice
  • Key pitfalls and lessons learned from audits/inspections
  • Final Q&A and take-home actions

Richard Young has over 25 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

 

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.

This course is suitable for:

  • Regulatory Affairs and Quality professionals
  • R&D and Design Engineers
  • Manufacturing and Operations teams
  • Clinical, Safety, and Post-Market teams
  • Anyone involved in technical documentation or device approvals

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8 & 9 September 2026 | 2-Day Live Online Course

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