April 8th, 2015
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
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
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