Results 5 found
February 10th, 2016
FDA publishes HFE Guidance documents

Consistent with its increased scrutiny of human factors engineering studies in submissions over the last 5 years, FDA has issued one final and two draft Guidance documents in the area of Human Factors Engineering (HFE) including: Applying Human Factors and Usability Engineering to Medical Devices Draft Guidance – Human Factors Studies and Related Clinical Study Considerations in Combination Product… read more

November 4th, 2015
Michael Wiklund & Jon Tillis presenting “Applying Human Factors in Medical Software Development” at BostonCHI

Michael Wiklund, General Manager of Human Factors Engineering (HFE) and Jon Tillis, Design Director speaking on “Applying Human Factors in Medical Software Development” at BostonCHI Boston, MA USA The presenters will summarize the regulators’ expectations pertaining to different software products and how best to meet them. For instance, they will discuss how to define user interface requirements… 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

July 27th, 2015
Medical Device Use Error – Root Cause Analysis

Thursday, September 10th; 11:00 am EDT, 60 mins. During their 60-minute webinar presentation, senior members of UL’s human factors engineering practice will describe the regulatory and commercial imperative to identify the most likely root causes of medical device use errors. They will reflect on the harm that arises from use errors involving diverse medical devices,… 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