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
    • reduce the training costs for both manufacturers and end-users.

Visit our main page for clear and educational resources and guidance, including:

  • Standards for Human Factors Engineering
  • FDA Requirements
  • Articles & Published book resources
  • Podcasts and recorded webinars

Visit the page here

Contact the European team to learn more