5 News & Press Releases found

BSI Consulting news

BSI introduces entropy software for healthcare product manufacturers

BSI Group America Inc. (BSI), a leading global provider of ISO-standards-based assurance, compliance, and information solutions, is pleased to introduce Entropy Software for the healthcare industry. Entropy Software is a market-leading quality management software solution to assist organizations to deliver products to market on-time with transparency, real-time reporting, and improved quality and compliance assurance. Designed and developed to meet recognized international standards, Entropy

Jun. 12, 2011

BSI group America Inc. Announces specialized regulatory training courses for the healthcare industry

BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of Specialized Regulatory Training courses targeted specifically for the medical device industry. Available on-site, these Specialized Regulatory Courses reflect requirements of the latest amendments to the Medical Device Directive enabling attendees to comply efficiently with regulations in a timely manner. Courses are lead by expert trainers who understand the industry and regu

Apr. 27, 2011

BSI extends healthcare rReach with Eurocat acquisition

BSI, the global standards and assessment body, has acquired German healthcare certification and testing business, EUROCAT. This development significantly enhances BSI’s ability to service the medical device market globally.

EUROCAT is an established Notified Body offering healthcare systems and product certification. The company has a significant presence in Germany - the third largest medical device market in the world – complementing BSI’s existing business there and strengthening

Nov. 30, 2009

BSI expediting expansion of in vitro diagnostic scope for medical devices

BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, is rapidly implementing plans to expand its medical device Notified Body scope to include in vitro diagnostic (IVD) devices. BSI has appointed Sue Spencer, an IVD industry veteran, to lead what looks to be an early 2010 expansion. Spencer is focusing on the accreditation process along with creating a dynamic team of in-house experts. The new expansion will make BSI

Nov. 30, 2009

BSI launches new CE-Dedicated FastTrack Program at RAPS Conference

BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, today announced the launch of CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their products quickly and safely to European markets. BSI will debut the program at the 2009 Regulatory Affairs Professionals Society (RAPS) Annual Conference taking place September 13-16, 2009, in Philadelphia.

CE-Dedicated

Nov. 30, 2009