HiFEM-Analysis I Risk management

Medical products are subjects of risk analysis to identify device and user control errors. For products with risk potential we examine apart from the classical FMEA (failure mode and effect analysis) a new method of analysis. This HiFEM method (human inducted function effect modelling) optimizes the man-machine interaction right from the start. (Research partner www.innorisk.net).

We use this very safe method for usability examination already in an early development phase and during the entire design process. This avoids any risk of expensive erroneous trends.

 

  • Risk analysis and usability examination according to HiFEM or FMEA
  • Evaluation of potential man-machine interaction error sources
  • Workshop for new features and future device generations
  • Design conception
  • Software prototyping

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