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user interface

Spotlight on Human Factors Engineering: Should kids be operating medical devices independently?

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Manufacturers whose intended users include children must consider pertinent human factors and usability issues when designing their medical devices.
  • Issues pertaining to working memory capacity in children should be accommodated by companies whose devices target minors to ensure safe and effective use.

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)