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7 reviews for
Introduction to IEC 62366: Human Factors and Usability for Medical Devices
21 May 2026 | Short Online Course
£280 £350Price range: £280 through £350
1-day live online training | Understand the basics of Human Factors and Usability for Medical Devices and IVDs
Learn more about the course by toggling through the tabs below.
Course Overview
Medical devices continue to grow in complexity with continuous innovations. In addition, device users are becoming less skilled and are often the patients themselves. As a result, the latest requirements in the Medical Device Regulation (MDR), emphasises the usability of a medical device. It is critical for device manufacturers to demonstrate their device is easy to use and will result in minimal errors of use.
In this training course you will gain a comprehensive overview of human factors and usability for medical devices. You will examine the standard IEC 62366 that outlines the process you must follow to ensure your device is easy to use. You will examine how to design and evaluate a device and discuss how to manage the risk of use errors.
Key Learning Objectives
- Identify the links between the Medical device Regulation and IEC 62366
- Learn how to use design guidance in ANSI/AAMI HE75: 2009
- Explain terms and definitions
- Define the usability requirements
- Identify the methodology used
- Develop a usability engineering process
- Define the key documents of the usability file
Who Should Attend?
The course is designed for those who must have an understanding of human factors and usability. These include professionals in design and development but also regulatory and risk managers responsible for device compliance. These include:
- Product Design Engineers
- Project Managers
- Regulatory Affairs Professionals
- R&D Personnel Risk Management Staff
- Quality
- Clinical Professionals
Course Outline
Course Information
- The course begins at the time stated at the top of the page
- The course is broken up into modules outlined below
- There will be breaks between modules
21 May 2026 | 10 November 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
approx. 120 mins | 10:00 AM UK
Introduction to usability engineering
- What is meant by usability?
- Review GSPR under the MDR
- Examine the FDA regulations
- Legal framework for manufacturers
- Overview of usability engineering process in IEC 62366-1:2015
Risk management and usability
- Design and development planning of your device
- Review of the risk process and risk management activities
- Examining how risk management integrates with usability
- Why do use errors occur?
- What is human error?
- Case studies involving use error
- Techniques to manage use error
Discussion and Q&A: There is time for interactive discussion where you can discuss your specific products and challenges.
Session 2
approx. 120 mins | 1:00 PM UK
Usability evaluation
- Step by step to delivering usability
- Processing information
- Summative evaluations
Usability documentation and integration
- The Usability engineering file
- Integration with design and Risk Documentation
- US Documentation
- Developing and implementing a usability engineering process Discussion:
Discussion and Q&A: There is time for interactive discussion where you can discuss your specific products and challenges.
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.
In a changing regulatory environment, communication with customers and end users is a critical element for all manufacturers in the life sciences sector. The content of labelling and internet communications is a vitally important part of the development and maintenance of compliance of all medical products. Richard has extensive experience in regulatory and quality roles for all classes of medical products and offers you a unique insight into the practicalities and requirements of human factors in todays markets.
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
21 May 2026
1-Day Live Online Training
Register at the top of the page.
10 November 2026
1-Day Live Online Training
Register at the top of the page.
On-Demand Access
Can’t wait for the next course date?
Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
Course Times
For live online delivery, the course starts at 10:00 AM (UK time) and finishes at 3:00 PM (UK time).
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.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Access to Recordings for 2 Weeks
Enjoy unlimited access to all session recordings for up to two weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
On-Demand or Live Online
This course is delivered live or you can access on-demand materials immediately to begin learning straight away.
4 Hours of Learning
This course includes a total of 4 hours of learning.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
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 either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- 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.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
7 reviews for Introduction to IEC 62366: Human Factors and Usability for Medical Devices
21 May 2026 | Short Online Course
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BioTop Medical (verified owner) –
n/a
Springboard Pro (verified owner) –
I enjoyed the interactivity of it. Overall I think it is a good course for any member involved in the design of a medical device and does not have much pre-existing exposure to human factors.
CMR Surgical Ltd –
n/a
CMR Surgical Ltd –
n/a
Individual Booking –
Good value for money as you cover a lot of content. My only recommendation is to make it slightly longer.
Alkaloid AD Skopje –
The material presented was detailed, exceptionally clear, and well structured. It provides a strong foundation and will be highly applicable to our D&D projects going forward.
Alkaloid AD Skopje –
The training was excellent – both highly informative and instructive. It introduced new ideas, broadened our understanding of potential possibilities, and highlighted scenarios we had not previously considered.