January 5th, 2017

What to look for in a Notified Body

A Notified Body is approval is required for higher risk medical and IVD devices in the EU.  This business relationship is intended to be long-term and it’s best to be prepared. UL Notified Body staff have collaborated on an article titled “Critical Things to Consider When Looking for a Notified Body” that lists the top 11 things… read more

October 24th, 2016

UL Northbrook expands CBTL scope with 3 additional IEC 60601 Medical Particular Standards for use with IEC 60601

UL has expanded its scope at its Northbrook, IL laboratory and can now offer IECEE CB Scheme testing, reports and certificates to three ISO 80601 Particular standards. ISO 80601-2-35:2009 Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for… read more

October 14th, 2016

PRE-RECORDED WEBINAR: Business Impact of the new EU IVD Regulation – An Executive Brief with Sue Spencer

About this webinar: In this 30-minute pre-recorded webinar, Head of UL Global Medical Device Services, Sue Spencer shares her expertise in what to expect from a business standpoint for the new EU IVD Regulations. The European Union IVD “revolution” has been in motion since 2012. Many of the larger companies are already putting the systems… read more

October 13th, 2016
PRE-RECORDED WEBINAR: Validation needs for packages of medical devices
October 6th, 2016
PRE-RECORDED WEBINAR: 66/585/FDIS – IEC 61010-1 3rd Edition – Amendment 1
August 26th, 2016
PRE-RECORDED WEBINAR: Broader Regulatory Oversight of In Vitro Diagnostic Devices: A Deep Dive into the changes to the EU IVD Regulations
August 25th, 2016
UL experts share safety lessons for injectable devices
August 19th, 2016
PRE-RECORDED WEBINAR: Changing In Vitro Diagnostic Device Regulations: A Deep Dive into the New EU Requirements for Clinical Evidence
July 29th, 2016
UL Featured in Popular DC Podcast
July 19th, 2016
UL Article published on 3D Printed Devices