Mar 13, 2018
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:
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.
EMERGO SUMMARY OF KEY POINTS:
US medical device regulators have specified types of devices for which premarket application submissions should include human factors testing information, according to new Food and Drug Administration guidance.
The US Food and Drug Administration (FDA) has published a 37-page draft guidance for industry on proper human factors testing and medical device design optimization.