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human factors engineering and usability

Potential Advantages and Disadvantages of Electronic Instructions for Use (eIFUs) for Medical Devices

EMERGO BY UL SUMMARY OF KEY POINTS:

  • India has become the latest medical device market whereby regulators have begun accepting electronic indications for use (eIFU) for registrations.
  • Manufacturers can realize advantages of utilizing eIFU, but should consider how eIFU may impact other design, labeling and user interface issues.
  • Markets including the US and European Union already recognize eIFU for medical device premarket submissions.
Electronic Instructions for Use (eIFUs)

When the human factors specialist becomes the patient

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Medical devices engineered and designed for clinical end-users often overlook the factor of patient experience.
  • HFE and usability professionals should consider the impact of their designs not just for clinicians but also patients on the receiving end of such devices.
  • Designing devices and systems that better foster positive patient experiences deserves closer attention.