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

3 November 2022 | Short Online Course

£236.00

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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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.

What is Included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

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

Learn more about the course by toggling through the tabs below (trainer, agenda, 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 November | approx. 120 mins | 10:00 AM UK

Introduction to usability engineering

  • What is meant by usability?
  • Legal framework for manufacturers
  • Overview of usability engineering process in IEC 62366-1:2015

 

Managing the risk of use error

  • Why do use errors occur?
  • Case studies involving use error
  • Techniques to manage use error

 

Discussion: Experiences and challenges

Session 2

3 November | approx. 120 mins | 1:00 PM UK

Usability evaluation

  • Formative evaluations
  • 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:
  • Next steps 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
Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

 

Complete our contact form by following the link. Get in touch.

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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training