In-company training

Gain an understanding of usability engineering and how it should be applied to medical devices by attending this BS EN 62366 Usability Engineering training course.

The 1-day usability engineering workshop explores the usability engineering methodology detailed in BS EN 62366, from analysing and specifying the design, through identifying potential risks, to verifying and validating the user interface. The tutor will use a combination of teaching, interactive workshops and group discussions around the development of a real product to explore the application of usability engineering.

Delegates will learn how to expand their current risk management activities to ensuring the user interface of their medical devices is safe and effective, in line with the expectations of the EU and FDA in the US.

This course provides valuable information for those involved in the design and development of medical devices, including:

  • R&D managers/engineers
  • RA/QA managers/engineers
  • management representatives
  • members of multi-discipline design teams
  • members of design review teams
  • ergonomic designers
  • usability engineers
  • product, project, and programme managers
  • Internal auditors

The course complements Bywater’s range of courses applicable to the medical device industry.

Key topics covered on this course include:

  • expectations of the FDA and the EU in applying usability analysis to medical devices
  • applying the usability management standard BS EN 62366 to medical devices
  • the relationship between ISO 14971 and the EU directive and the implications the changes represent
  • usability and use errors and examples of risks associated with user interfaces
  • the stages of the Usability Engineering Process
  • application of usability analysis methodologies, such as FMEA, to medical devices
  • principles of usability management planning in developing procedures and practices to analyse, evaluate and control usability
  • sources of information and further development

By the end of this training course, delegates will be able to:

  • apply the Usability Engineering Process in BS EN 62366 to medical devices and to conduct usability analysis to identify hazards and possible use errors
  • understand how to prepare the documents for the key stages of the Usability Engineering Process: application specification, primary operating functions, characteristics relating to safety, hazard identification, usability specification, usability validation plan

A certificate of completion will be awarded to delegates who attend and fully participate in the course, which recognises their new understanding of the Usability Engineering Process.

BS EN 62366 Usability Engineering for Medical Devices Certificate