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Our medical device development process ensures that the needs and safety of users – such as the patient and healthcare professional - are considered from the earliest possible opportunity.

The work we conduct is led by Human Factors standards IEC 62366 standards and FDA Guidelines. These ensure that the usability engineering and human factors engineering we conduct delivers the best possible outcomes from the use of the device.

Our human factors engineers ensure that the risks associated with both the correct use and use error are identified. In addition, this work may also help identify potential abnormal use cases.

Typical work we conduct includes:

  • Human factors / usability planning
  • Use specification
  • User interface requirements & specification
  • User centre design
  • Identify hazards and hazardous situations
  • Identify and describe hazard-related use scenarios
  • User interface evaluation planning (formative & summative)
 

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