online, Akademie: Basic course - UX and usability for medical software and apps according to IEC 62366-1

In this hands-on training, you will learn how to implement user experience (UX) and usability for medical software.

This starts with the topic of user research, in order 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 phone again and again, even though this would only be necessary at the end, then the context has not been properly understood. This can be done with systematic UX and usability methods.

Then usage requirements are defined and, for medical devices, usage errors are passed through the interface to risk management for evaluation.

This is followed by the translation into a design solution including the risk control measures. Since human behavior is not easy to predict, the design solutions are then evaluated. This can also be done by experts, but tests with users, called usability tests, are the decisive factor.

For medical software and apps, IEC 62366-1 must be met in Europe. In the USA, an FDA guidance document entitled „Applying Human Factors and Usability Engineering to Medical Devices“ applies. Here, usability testing is required at the end of development. The corresponding telemetry data of the software can be used for market monitoring.

These activities require a good understanding of UX and usability engineering which we will provide you with in this seminar.

This basic course is also suitable for participants with no or little previous knowledge. For industry career changers and start-ups, this course offers an optimal introduction to the topic.

This basic course is part of our online course: Medical Software Specialist!


  • Legal basis according to MDR and IVDR
  • Norms and standards esp. IEC 62366-1:2015+AMD1:2020
  • Integration of usability engineering into risk management
  • Integration of usability engineering into development
  • User Research as the basis of the Use Specification according to 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 for the improvement of prototypes
  • Summative evaluation for the validation of risk control measures
  • Usability Engineering File and Human Factors Engineering Report