Seminars
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