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Friday, May 19 • 9:15am - 10:00am
Usability Validation Testing of Medical Devices and Software

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The U.S. FDA and international regulatory bodies require usability testing of medical devices, products, software, and systems as part of their overall validation. Manufacturers must demonstrate that all potential use-related hazards have been identified, prioritized, and mitigated. The method for demonstrating this is human factors/usability engineering (HF/UE) validation testing. However, the way we conduct these studies is in many ways different from the way we conduct studies of non-medical products and systems.

This topic is relevant to the Boston UX community given the convergence of consumer and medical devices, as well as the rise of wearable technologies and the apps that interact with them. This presentation will cover the key aspects of HF/UE validation (a.k.a. ‘summative’) testing and what the FDA expects in the final HF/UE summary report.

Importantly, this session will consist of half presentation and half Q&A, with the audience driving the discussion toward current issues, questions, and challenges that are relevant to them.

avatar for Beth Loring

Beth Loring

Principal, Loring Human Factors, LLC
I've been part of the Boston UXPA scene for a long time. My mentor, Joe Dumas, encouraged me to attend a Greater Boston SIGCHI meeting in the late 80's, and I eventually became chairperson. My 5+ years as Director of the Bentley Design and Usability Center (now UXD Center) gave me... Read More →

Friday May 19, 2017 9:15am - 10:00am EDT
2-Backbay A/B