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