Search Tag: MDR
2021 02 Jul
Sedana Medical AB (publ) today announced that the company has received an approval for its quality system (QMS) according to the EU Medical Device Regulation (MDR) 2017/745. The approval means that Sedana Medical's Class I medical device accessories can continue to be sold with CE marking within the EU. "The new EU Medical Device Regulation (MDR)...Read more
2019 08 May
Candida auris ( C. auris ) is a type of fungus first isolated in 2009; since then there have numerous infection episodes and outbreaks in different regions of the world. In the U.S. alone, 560 cases of C. auris infections have been reported as at 31 January 2019. Overall, most of those affected were critically ill adults, with risk factors for...Read more