Since the late 1990s, FDA has expected Class II and III medical device manufacturers to apply human factors engineering (HFE) comprehensively to help reduce the chance of harm due to use errors. In 2016, FDA updated its HFE guidance to industry, specifying that submissions should include an HFE Report if the associated device requires users to perform safety-critical tasks.
In this 60-minute live webinar, two of UL’s HFE experts will (1) review the basics of preparing an HFE report, (2) discuss the lessons they have learned writing and defending them on behalf of clients, and (3) answer audience member questions.
The presenters will discuss the importance of documenting how a use-related risk analysis helped drive the device’s user interface design and served as the basis for validation testing. They will offer advice on how to support a claim that a device is safe for use despite the occurrence of interaction problems (e.g., use errors, close calls, difficulties) during a summative usability test. They will discuss how to put a device’s residual, use-related risk into proper perspective in relation to its benefits. And, they will comment on the benefits of writing a well-organized, concise, and illustrated document that eschews “spin” in favor of objective reporting.
Audience members will learn the importance of starting the HFE reporting effort early and committing sufficient resources to the task to produce a compelling end-product that could spell the difference between device approval and rejection.
Date: Tuesday, September 12th, 2017 (Wednesday Sept. 13th local Asia time zones)
Time: 10 PM Eastern time (GMT -4); 10:00 China local time
Where: Live online
Michael Wiklund, CHFP*, PE, MS, General Manager – Human Factors Engineering
Merrick Kossack, CHFP, MS, Research Director, Chicago/Northbrook