February 11th, 2016

UL and MasterControl publish “ISO 13485- Change? Do I have to?” article

With the anticipated release of ISO 13485 this month, UL’s Linda Chatwin Esq., RAC and MasterControl’s Walt Murray, outline the changes and impacts the new requirements will have in their article “ISO 13485- Change? Do I have to?” With companies wondering if they want to maintain ISO 9001 and ISO 13485 certification, Chatwin and Murray… read more

December 2nd, 2015

Brazil set to require IEC 60601-1-9 by 2016

UL Principal Engineer Pamela Gwynn, recently attended an IEC Technical Committee (TC) 62* meeting in Kobe, Japan where she learned that Brazil’s ANVISA will be starting  to mandate compliance with 60601-1-9** for all medical electrical devices. This intention was confirmed by UL’s Brazil team who explained, the ABNT NBR IEC 60601-1-9:2014 (Portuguese translation of IEC… read more

October 27th, 2015

Computerworld highlights UL’s efforts to develop privacy and security standards for connected devices

In a recent article published by Computerworld, reporter Matt Hamblen and Medical Software & Systems Interoperability Principal Engineer Anura Fernando discuss the current work being done by UL to develop draft security and privacy requirements for data associated with Internet of Things devices, including wearables. Click here to read the entire article.

October 26th, 2015
UL Presents at CIMDR: Bringing Global Regulatory Consulting and Market Access Services to Medical Device Enterprises
September 16th, 2015
UL’s Michael Wiklund discusses manufacturers approach to Human Factors Engineering with MedTech Intelligence
September 15th, 2015
Updated OSHA NRTL Directive expected for Fall Release
September 14th, 2015
CIO.com article highlights UL expert Anura Fernando’s insight on healthcare apps
August 14th, 2015
UL Expert quoted in article featuring UL Testing Safety, Privacy Issues Related to Wearable Devices
August 11th, 2015
UL’s Alex Hussein Discusses Medical Devices and Biocompatibility with Texas TECH Talk
August 11th, 2015
FDA extends EMC standard transition date to April 1, 2017