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

South Korea sets 2016 deadline for Clinical Investigation for some Class IV medical devices

Starting in January 2016, Korea’s Ministry of Food and Drug Safety (MFDS) will require clinical investigation data from some of Class IV medical device items.  A total of 63 product types in the following 12 product groups have been identified: Artificial internal organ apparatus Physical Devices for Medical Use Cardiovascular Devices Instruments for Ligature and… read more

March 12th, 2015

IEC issues 2nd edition of IEC 60601-1-11, Medical Equipment in the Home Healthcare environment

Earlier this year, the IEC finalized and published the latest edition of IEC 60601-1-11:2015, the Collateral standard for medical devices used in the Home Healthcare environments. Manufacturers of applicable devices need to consider the additional risks posed as more devices move to support patients and health outside of the clinical environment, including ease of use,… read more

February 10th, 2015
What Does ACLASS/ANAB* Accreditation Mean for UL Registrar?
December 16th, 2014
UL publishes article on changes to Medical EMC standard
October 31st, 2014
OSHA expand the scope of recognition for UL as a Nationally Recognized Testing Laboratory (NRTL) under AAMI ES60601-1 with Amendment 1
October 23rd, 2014
FDA Considerations for Home Use Devices
October 21st, 2014
FDA adds 4th edition of IEC 60601-1-2 to list of EMC consensus standards
September 18th, 2014
IECEE change requires medical devices to comply with IEC 60601-1-6
August 12th, 2014
Directory of Contacts for UL Health Sciences Division