Results 10 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scrutiny of human factors engineering studies in submissions over the last 5 years, FDA has issued one final and two draft Guidance documents in the area of Human Factors Engineering (HFE) including: Applying Human Factors and Usability Engineering to Medical Devices Draft Guidance – Human Factors Studies and Related Clinical Study Considerations in Combination Product… read more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

September 16th, 2015
UL’s Michael Wiklund discusses manufacturers approach to Human Factors Engineering with MedTech Intelligence

In the  recent MedTech Intelligence article “Does Your Device Play Well with Others,” Maria Fontanazza spoke with UL-Wiklund’s general manager Michael Wiklund about how manufacturers should approach investment, product development, and application standpoint in regards to human factors.   Click here to read the entire Q&A

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

April 8th, 2015
UL HFE experts share knowledge on writing effective IFUs for medical devices in podcast

In this “Silver Sheet” podcast, Michael Wiklund and Jonathan Kendler of UL-Wiklund Research & Design share knowledge on writing effective instructions for use so your firm can avoid costly mistakes. Wiklund is general manager for the Concord, Mass.-based Human Factors Engineering services firm, while Kendler serves as its design director.

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

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