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    https://www.iso.org/standard/63179.html
    IEC 62366-1:2015 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits …

Human Factors and Usability Engineering to Medical …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices
    Applying Human Factors and Usability Engineering to Medical Devices. FDA has developed this guidance document to assist industry in following appropriate human …

ISO 62366 and Usability Requirements for Medical …

    https://www.qualitymeddev.com/2020/11/07/iso-62366/

    Medical Device Usability - BSI Group

      https://www.bsigroup.com/meddev/LocalFiles/en-GB/Events/UK-Consultants-Day-2015/BSI-md-consultants-day-usability-and-human-factors-presentation-UK-EN.pdf
      New Standards • BS EN 62366:2008 + A1 2015 • 5.10 User interface of unknown provenance • Annex K – Evaluation of a user interface of unknown provenance • IEC …



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