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)