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

3 December 2024 | Short Online Course

Original price was: £295.00.Current price is: £236.00.

(5 customer reviews)

1 day live online training | Starts 10 AM UK Time

Understand the basics of Human Factors and Usability for Medical Devices and IVDs

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Enrol before 8 November to save 20% (December Course)

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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

 

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.

 

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

 

  • 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

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Course Dates

 

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

3 December 2024

1-Day Live Online Training
Register at the top of the page.

28 May 2025

1-Day Live Online Training
Register at the top of the page.

8 December 2025

1-Day Live Online Training
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 at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1

3 December 2024

28 May 2025

8 December 2025

 

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

3 December 2024

28 May 2025

8 December 2025

 

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.

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

5 reviews for

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

3 December 2024 | Short Online Course

  1. BioTop Medical (verified owner) –

    n/a

  2. 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.

  3. CMR Surgical Ltd –

    n/a

  4. CMR Surgical Ltd –

    n/a

  5. Individual Booking –

    Good value for money as you cover a lot of content. My only recommendation is to make it slightly longer.

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