Center for Usability &
Risk Engineering of Medical Devices


Usability Engineering of medical devices

  • Medical device usability and ergonomics
  • Usability engineering process
  • Legal and normative aspects
  • Design of human-machine interfaces
  • Specification of typical user, use context, environmental factors, primary operating and risk sensitive functions, etc.
  • Specification of the usability, using the criteria: effectiveness, efficiency, learnability and user satisfaction
  • Methods for the design, verification and validation
  • Formative and summative user tests
  • Formal-analytical, criteria-based and interaction-centered usability evaluation in our usability lab
  • Test design, realization and statistical evaluation
  • mAIXuse – Model-based usability evaluation of the human-machine interface
  • Human-risk analysis and completion of the risk management file
  • Completion of the usability file
On the basis of:

  • IEC 62366 (Medical devices – Application of usability engineering to medical devices)
  • FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices”
  • AAMI HE 75 “Human Factor Engineering – Design of Medical Devices”
  • ISO 9241 (Ergonomics of human-system interaction)

Risk analysis for medical devices according to ISO 14971 (Medical Devices – Application of Risk Management to Medical Devices)

  • Process-oriented risk analysis with CARAD (Computer Aided Risk Analysis and Documentation)
  • Technical risk analysis using the FMEA (Failure Mode and Effects Analysis) and FTA (Failure tree analysis)
  • Technical-, usage- and manufacturing-related risk analyses
  • Iterative development of risk management file

Medical device software according to IEC 62304 (Medical device software – Software life-cycle processes)

  • Software development process
  • Software maintenance process
  • Software configuration management and problem solving process
  • Software risk management process

Application of risk management for IT networks with medical products according to IEC 80001

  • Tasks, responsibilities and activities
  • Safety, effectiveness as well as data and system security
  • Responsibility for the compliance of the safety object of the IT network
  • Evaluation of the functionalities