Results 8 found
September 28th, 2017
PRE-RECORDED WEBINAR: Writing HFE Reports for Submission to FDA

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… read more

March 22nd, 2016
US FDA Medical & Combination Product Regulatory Submissions: Human Factors – FDA’s New and Renewed Expectations About this Webinar Now Available to View Online

In this pre-recorded webinar, UL HFE experts discussed the FDA’s new and renewed expectations regarding the application of Human Factors Engineering (HFE) to medical devices that call upon users to perform critical tasks.  The discussion centered around our experts’ experience helping customers generate appropriate human factors data to support pre-market submissions. The recording includes responses… read more

October 2nd, 2015
UL HFE team writes usability guidance for US National Institute of Standards and Technology

The UL Human Factors Engineering team recently completed a project for the US National Institute of Standards and Technology (NIST) in support of its Health IT Usability initiative. The project entailed developing guidance on designing user interfaces for Electronic Health Records (EHR) that help ensure their safe and effective use. The 192-page publication titled “Technical… read more

March 30th, 2015
UL’s Allison Strochlic presenting “Applying Human Factors Engineering to Support FDA and CE Mark Submissions”- RAPS Texas Chapter

UL’s Allison Strochlic presenting  “Applying Human Factors Engineering to Support FDA and CE Mark Submissions” Today, human factors engineering (HFE) is an imperative. FDA’s human factors engineering (HFE) guidance (published in June 2011) and IEC 62366:2007 (Usability) place intense HFE expectations on medical device developers. These high expectations apply to new products and, in some… read more

September 18th, 2014
IECEE change requires medical devices to comply with IEC 60601-1-6

Many device manufacturers utilize the CB Scheme to obtain acceptance of test reports and certificates by National Certification Bodies. As such, manufacturers must be familiar with the latest regulatory changes. One such change is the recent requirement for manufacturers of medical electrical equipment to comply with IEC 60601-1-6 (and by extension IEC 62366) as part… read more

September 17th, 2014
Human Factors Engineering for Medical Devices – IEC 62366 and IEC 60601-1-6

The safety of medical devices extends beyond electrical safety so that the people who are using and applying the medical device must be able to do so safely and effectively.   There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design, including “usability,” “human factors engineering (HFE)” and… read more

March 16th, 2014
UL Experts Provide Insights into HFE and Medical Device Design

Medical devices manufactured today require significant attention to safety and human factors engineering that has not always been exercised in medical device design. IEC safety standards mandated by the general standard, IEC 60601-1, updated to the 3rd edition, and now Amendment No. 1 to that standard, require testing and verification of devices and essential performance,… read more

March 10th, 2014
UL Experts provide insights into HFE and medical device design in the January issue of Medical Design Briefs

UL’s Linda Chatwin, Maureen Mulcare and Jeff Rongero, recently published an article in Medical Design Briefs titled “Safety and Human Factors Engineering in Medical Device Design.” As the article states, “Ultimately, manufacturers must validate that the product’s users can employ the device safely and effectively in the intended use environments” which is why Usability is… read more