sigma biomedical

Human Factors Validation

Testing Services

Human factors validation testing (HFVT) is a critical process that assesses whether the medical device can be used safely and effectively by its intended users—such as physicians, nurses and technicians—under real-world conditions. This testing involves simulating typical usage scenarios to identify potential critical tasks and use errors, particularly those that could lead to serious harm. By incorporating human factors engineering early in the design process, manufacturers can mitigate these risks, leading to improved patient safety and device usability.​ Sigma offers human factors validation testing including participant recruitment and protocol development. Reports as per required by regulatory agencies such as the US FDA 

HFVT Protocols and Methods

HUFVT Protocols and Validation Methods include

  • User Related Risk Analysis URRA
  • Definition of participants, sample size and use environment
  • Training on the user of the subject medical device
  • Training clinicians on human factors validation methods
  • IEC 60601-1-6 Medical electrical equipment –Part 1-6: General requirements for basic safety and essential performance –Collateral standard: Usability
  • IEC 62366-1 Medical devices –Part 1: Application of usability engineering to medical devices
  • FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices, Feb 3, 2016 

Test Reporting

The human factors validation test report contain the following sections as per the FDA Guidance on Human Factors and Usability Engineering:

  • Conclusion
  • Intended Users, Uses, Environments, and Training
  • User Interface Description
  • Known Use Issues 
  • Use-Related Hazards and Risk Analysis
  • Preliminary Analyses and Evaluations
  • Critical Task Identification and Scenarios
  • Human Factors Validation Testing