(BSI: Reston, VA) -- BSI, a provider of regulatory and quality management reviews and product certification for medical devices, recently launched the 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 debuted the program at the 2009 Regulatory Affairs Professionals Society (RAPS) Annual Conference.

CE-Dedicated FastTrack offers thorough, high-quality reviews at an accelerated pace—within 45 working days or less. The program’s unique feature is that BSI product experts dedicate a period of time to work exclusively with a particular client to complete the review. No traveling to the customer site is required. In addition, CE-Dedicated leverages an array of communication technologies, paperless submissions, and expertise that can speed up the review process to get new medical devices into the European market and in turn, provide patients more rapid access to new technology.

 …