Results 9 found
October 13th, 2016
PRE-RECORDED WEBINAR: Validation needs for packages of medical devices

The quality and efficacy of a medical device does not end once it’s off the manufacturing line. Typically, the final devices are packed. Such packaging processes need to be validated. Additionally, as the packaged devices are not sterilized and immediately used at the location of the packaging process, both the transport impact and the storage… read more

November 3rd, 2015
UL Reinforces Thought Leadership in the Medical Device Innovation at AdvaMed and CIMDR

PRESS RELEASE    SAN DIEGO, November 3, 2015 – UL (Underwriters Laboratories), a global safety science organization, continued to exemplify its commitment to safety and learning in   the medical device industry sector by moderating one of the “CEOs Unplugged” sessions at AdvaMed’s annual conference in San Diego. UL’s mission for a safer world resonates closely… read more

August 5th, 2015
AAMI/FDA Risk Management Summit

Mark Leimbeck presenting in a panel discussion Tuesday, Sept. 29th from 2:15-3:15 pm “Learning from the Unique Challenges of Start Ups”. Register online

July 27th, 2015
UL’s Anura Fernando provides expert insights in reporter Shaun Sutner’s article “FDA and UL weigh in on security of medical devices, IoT”

As IoT increasingly moves into healthcare, and data from wearable health devices flows more from consumers’ wrists to physicians’ charts, the Food and Drug Administration (FDA) is trying to keep pace with the fast-evolving technologies. Meanwhile, a well-known private organization interested in the safety and security of medical devices has stepped up its efforts in… read more

July 16th, 2015
UL Maintains Global Market Leadership in Medical Device Category for IECEE CB Test Certificates

NORTHBROOK, Ill. July 14, 2015 – UL (Underwriters Laboratories), a global safety science organization, announced today it remains the global market leader in issuing IEC System of Conformity Assessment for Electrotechnical Equipment and Components (IECEE) Certification Body (CB) Test Certificates for medical electrical devices (MED). UL, including its global subsidiaries, has been the overall leader… read more

April 14th, 2015
IEEE PSES Meeting with Anura Fernando

UL’s Anura Fernando will be speaking on the following topic at this month’s IEEE PSES meeting. To be, or not to be…a medical device?    Go-to-market strategies for Wearable Tech: Many manufacturers of WT products which were initially introduced into the consumer product market see value in bringing their products into the medical device realm to… 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 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

January 29th, 2014
UL’s Notified Body Toolkit

The EU is one of the most attractive markets for medical device and IVD sales. UL’s Notified Body toolkit provides 34- pages of information on the EU regulatory system, including the classification rules, process for approvals and conformity assessment procedures. It also is a valuable reference document, with links to guidance documents, Interpretive documents and… read more