The safety of medical devices extends beyond electrical safety so that the people who are using and applying the medical device must be able to do so safely and effectively. There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design, including “usability,” “human factors engineering (HFE)” and “ergonomics.” HFE has been added to regulatory requirements to reduce medical device use error, create more operator friendly and intuitive devices and reduce the training costs for both manufacturers and end-users.

Regulatory Requirements

Demonstrating safe use through Human Factors Engineering is one of the key components required by the major regulatory agencies. Requirements for HFE are included in IEC 60601 3rd edition and IEC 60601-1-6. The 3rd edition requires compliance with the collateral standards to achieve compliance with the main standard. FDA has published guidance on HFE requirements for FDA submissions. It also has published a list of the 16 device categories that the agency will look for HFE or Usability studies.

Standards for Human Factors Engineering

  • ANSI/AAMI HE 75:2009, Human factors engineering – design of medical devices. Provides detailed guidance on how to perform specific human factors analyses and provides a wealth of design principles
  • ISO/IEC 60601-1-6, General requirements for basic safety and essential performance – Collateral standard: Usability
  • ISO/IEC 62366:2007, Medical devices – application of usability engineering to medical devices.



Our staff of experts offer several types of tests and issue an informative report, including:

  • Conduct summative usability tests
  • Conduct design critiques
  • Assess and mitigate use-related risk
  • Prepare documentation
  • Deliver workshops and seminars
  • Define a vision of the user experience
  • Identify specific user needs
  • Create a user research strategy plan
  • Provide usability guidance during implementation
  • Provide user interface design support
  • Conduct early-stage user experience research



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