February 11th, 2016
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
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
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.