UX and usability for medical software & apps according to IEC 62366-1

In this practice-oriented training course, participants learn how to implement user experience (UX) and usability for medical software.

It starts with user research to understand who the users of the software are and in which environment the software is used. If the user has to pick up the cell phone again and again, even though this is only necessary at the end, then the context has not been properly understood. This is possible with systematic UX and usability methods.

Usage requirements are defined and usage errors for medical devices are transferred to risk management for evaluation via the interface.

This is followed by the implementation of a design solution, including the risk control measures. As human behavior is not easily predictable, the design solutions are then evaluated. Although this can also be done by experts, tests with users, known as usability tests, are the decisive factor.

Medical software and apps must comply with IEC 62366-1 in Europe. In the USA, there is an FDA guidance document entitled “Applying Human Factors and Usability Engineering to Medical Devices”. Usability tests are planned at the end of development. The corresponding telemetry data of the software can be used for market observation.

These activities require a good understanding of UX and usability engineering, which is taught in this in-house seminar.

SEMINAR CONTENTS

  • Legal basis according to MDR and IVDR
  • Norms and standards, in particular IEC 62366-1:2015+AMD1:2020
  • Integration of usability engineering into risk management
  • Integration of usability engineering into development
  • User research as the basis for the use specification in accordance with IEC 62366-1
  • Use scenarios, critical tasks and analysis of use errors
  • User interface specification and pragmatic creation of requirements for the user interface
  • Formative evaluation to improve prototypes
  • Summative evaluation for the validation of risk control measures
  • Usability Engineering File and Human Factors Engineering report

Costs

1 day in-house training: € 3,890 (excl. VAT) for max. 10 participants
incl. seminar documents and certificate of attendance, plus travel expenses

your trainer

Dipl. Inf. (FH) Michael Engler, Managing Director of EMPIANA KG
Information about our trainers

Book now:

Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491