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Results for tag: "ISO 62366"

Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance - Webinar (Recorded) - Product Thumbnail Image

Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance - Webinar (Recorded)

  • Webinar
  • November 2022
  • 60 Minutes
  • Global
How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance - Product Thumbnail Image

How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

  • Training
  • 60 Minutes
  • Global
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance - Webinar (Recorded) - Product Thumbnail Image

Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance - Webinar (Recorded)

  • Webinar
  • October 2023
  • 60 Minutes
  • Global
From
Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance - Webinar (Recorded) - Product Thumbnail Image

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance - Webinar (Recorded)

  • Webinar
  • February 2023
  • 60 Minutes
  • Global
From
Human Factors/ Usability Studies following ISO62366, the FDA Guidance and the new FDA Draft Guidance - Webinar - Product Thumbnail Image

Human Factors/ Usability Studies following ISO62366, the FDA Guidance and the new FDA Draft Guidance - Webinar

  • Webinar
  • 60 Minutes
  • Global
From
  • 5 Results (Page 1 of 1)
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ISO 62366 is an international standard for the usability engineering of medical devices. It provides guidance on how to design medical devices that are safe and effective for users. The standard covers the entire product lifecycle, from design to post-market surveillance. It includes requirements for user interface design, usability testing, and risk management. The ISO 62366 market consists of medical device manufacturers, healthcare providers, and regulatory bodies. Manufacturers must ensure that their products meet the standard's requirements, while healthcare providers must ensure that the devices they use are safe and effective. Regulatory bodies must ensure that the standard is being followed. Some companies in the ISO 62366 market include Philips, Siemens Healthineers, Medtronic, Johnson & Johnson, and Abbott. Show Less Read more