Course overview

Introduction to IEC 62366:
Human Factors and Usability for Medical Devices

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. 

This 1-day training course enables you to gain a comprehensive overview of human factors and usability for medical devices. Our industry-leading expert will help you examine the standard IEC 62366 that outlines the process you must follow to ensure your device is easy to use. You will also examine how to design and evaluate a device and discuss how to manage the risk of use errors.
Format 

Virtual
Instructor-Led

Date / Time

Select your date below

Price

€755

Duration

8 Hours

Time

1pm - 5pm

Time Zone

GMT

Course Information

Dates & Prices
Course Syllabus 
What's Included
Technology Requirements
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Training Dates

We're currently finalising our 2024 course calendar. Register your interest below to be the first to receive new dates! 

Training Times

1 pm - 5 pm GMT
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Discounts 

Group booking discounts are available as followed:

• 3 – 5 attendees receive 15% discount
• 6 or more attendees receive 20% discount

Email our team at [email protected] and one of the team will provide you with your unique discount code or invoice. 

More than 8 attendees?

If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

What Is Included?

▪    Direct, live access to an expert trainer
▪    Access to the Meddev Solutions Training Portal
▪    Fully Interactive Course - Polls, quizzes and breakout sessions 
▪    Downloadable Resources 
▪    CoE Accredited Certificate of Completion
▪    Knowledge Checks
▪    Full Tutor Support 

Learning Objectives

By the end of this course, you will be able to:
  • Identify the links between the Medical device Regulation and IEC 62366
  • 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.

Technology Requirements

Operating system
Windows requirements: Windows 7 or later
Mac requirements: Mac OS X Yosemite 10.10 or later
Linux requirements: 64-bit, Ubuntu 14.04+, Debian 8+,openSUSE 13.3+ or Fedora Linux 24+

Processor
Windows requirements: Intel Pentium 4 or later
Mac requirements: Intel
Linux requirements: Intel Pentium 4 or later

Internet connection
Required

Zoom

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

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Meet your instructor

Richard

Consultant & Trainer 

Richard has a BSc in Botany and MSc in Microbiology from the University of Canterbury, New Zealand, and has over 30 years' experience in the medical device industry. His background spans surgical robotics and orthopaedic implants, through to cutting edge diagnostics systems and drug delivery systems.

Richard’s work has involved providing regulatory strategy from product development to worldwide market registration, the creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities.
His key experience covers cGMP/ ISO13485(Quality Assurance), GLP (Laboratory Testing), GCP (Clinical) and Regulatory Affairs. 

Training for your team,
your way

We understand that every company is different and face unique challenges everyday. At Meddev, we can tailor any of our courses around your organisation’s specific needs and products. 

Bespoke learning experience

Develop your course with a leading subject matter expert to meet the specific needs of your organisation

Maximise your budget

Cut unnecessary costs and allocate your budget on what matters most

Track employee progress

Keep track of your employees’ progression in your own workspace

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Frequently asked questions

When will I receive the course confirmation details? 

Once your booking has been placed and confirmed, you will receive an email which contains your account login details. You can access your payment receipts, course details, learning materials and more in your account! 

What is included in the course?

▪ Direct, live access to an expert trainer
▪ Access to the Meddev Solutions Training Portal
▪ Fully Interactive Course - Polls, quizzes and breakout sessions
▪ Downloadable Resources
▪ CoE Accredited Certificate of Completion
▪ Knowledge Checks
▪ Full Tutor Support 

Is this course live?

Yes! This course is completely live with a Centre of Excellence approved industry-expert. You can ask questions throughout the course as if you were in a real classroom. 

What time is this course?

We run this course from 1 pm - 5 pm GMT. If you can't make the live sessions, don't worry. We will record them, so you can catch up on anything you've missed!

Do I get a course certificate?

On successful completion of the course, you will receive a certificate of completion that can be used to demonstrate your knowledge to your employers and Notified Bodies. 

What payment methods do you accept?

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, and you require a PO, please email our team at [email protected]

Do you offer group booking discounts?

Absolutely! 3 – 5 attendees receive a 15% discount and 6 or more attendees receive a 20% discount. If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

Can I transfer my place to another colleague?

Yes of course. If you can no longer attend the course, you can transfer your place at no additional cost.

What application do you use for the training?

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
Ready to get started?