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AAMI Webinar on HFE Reports for Medical Device Manufacturers

A new webinar hosted by the Association for the Advancement of Medical Instruments (AAMI) will provide insights into preparing Human Factors Engineering (HFE) test plans and reports that existing regulatory guidance does not fully address.

The AAMI webinar, “Writing Human Factors Plans and Reports,” has been developed to cover the lack of sample work products in HFE guidance documents issued by the US Food and Drug Administration and other regulators.

The webinar takes place March 15, 2018 at 11am Eastern US time. Topics the webinar will cover include:

  • HFE project plans
  • Formative usability test plans and reports
  • Summative usability test plans and reports
  • HFE reports

Webinar presenters will include Michael Wiklund, Laura Birmingham and Stephanie Larsen of UL Wiklund. The webinar coincides with a new AAMI book, Writing Human Factors Plans & Reports for Medical Technology Development, authored by the webinar presenters.

The webinar’s target audience includes human factors engineers, user experience designers and researchers, quality engineers, regulatory affairs professionals and related personnel involved in HFE and usability issues in medical devices.

Read more about medical device HFE, design and usability on the UL Wiklund website.

Related medical device HFE information:

  • HFE and usability testing for medical devices
  • Whitepaper: US FDA usability studies for medical devices

Related News

UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

US FDA Prioritizes Devices Requiring Human Factors Reviews

Draft Guidance on Human Factors and Usability Engineering Issued by FDA

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