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Last updated on April 24, 2014 at 21:24 EDT

Latest Notified Body Stories

2012-06-28 06:29:23

RESTON, Va., June 28, 2012 /PRNewswire/ -- For U.S.-based medical device start-ups, speed to global markets is often the most pressing concern, but trying to move too fast often leads to preventable mistakes that could take the CE Marking process back to the drawing board, according to healthcare experts at BSI Group America, a leading Notified Body that helps companies comply with the essential regulatory requirements of the European Union. (Logo:...

2010-06-14 06:58:00

LONDON, June 14, 2010 /PRNewswire/ -- BSI is proud to announce the expansion of its world class Notified Body CE Marking Services to include the In Vitro Diagnostic (IVD) European Directive 98/79/EC. This new extension establishes BSI as a full-service Notified Body supporting all types of devices, encompassing medical, active implantable and now IVDs. BSI has been accredited with a comprehensive scope which includes all In Vitro devices listed in Annex II List A (high risk) and List B...