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Next public course date:

  • 19th March 2019 - London

Click 'Register' to reserve your place.

What you will learn:


  • The regulatory landscape and requirements for Human Factors Engineering in Medical Devices and Combination Products

  • The Human Factors and Usability Engineering Process (in-line with IEC62366-1) which includes how use risk is assessed from project start to final Summative Validation.

  • An overview on the Legacy Devices (Annex C) clause in IEC62366 and what evidence Manufacturers need to supply regulators with to qualify for this route to market.

  • What a Use Specification is, what information to include and how it inputs into all UE documentation and activities 

  • How to construct a User Interface Evaluation Plan, key considerations which will affect planning and how the User Interface Evaluation Plan should be combined with the overall project delivery plan. This includes considerations for packaging, Instructions and Training.

  • How to conduct a use related risk analysis (Task Analysis, PCA and uFMEA).

  • How to identify different types of use errors

  • How to conduct a review of all known use issues in the market.

  • How to identify critical and necessary tasks and how these relate to Formative and Summative Testing.

  • How to identifying user requirements and how to incorporate them into UE file documentation.

  • The key differences between Formative and Summative Testing (e.g. sample sizes, moderating styles etc)

  • Considerations for conducting Formative and Summative Evaluations (including a look at IFU testing)

  • How to assess task performance in studies (pass, pass with difficulty, close call and use error).

  • How to assess knowledge-based tasks

  • How to construct a HFE summary report 

  • How to make an assessment on the residual risk remaining before submitting to the regulator.

The 1 Day Human Factors and Usability Engineering File training aims to equip delegates with the ability to make decisions on which filing route they should take when putting together a Usability Engineering File for a product. 


The training gives delegates an in-depth understanding of all the elements of the Usability Engineering File and Usability Engineering process in-line with the expectations from IEC62366-1 and the FDA. 


This includes how to write a Use Specification, User Interface Evaluation Plan, Use Risk Analysis (Overview), User Interface Specification, Formative Evaluation (Overview), Summative Evaluation (Overview) and HFE Summary Report. 


This course is recommended for anyone involved with the research, design and development of a Medical Device or Combination Product.

Course details: