Press release - Reston, VA - September 14, 2009
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 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.
“We listened to our customers and have expanded the toolbox to offer different solutions to fit specific customer requirements,” said Paul Brooks, Vice President, BSI Healthcare and a RAPS Board Member. “CE-Dedicated demonstrates our continued commitment to view our services from the manufacturer’s perspective in order to make them more predictable, interactive and effective. We firmly believe that CE-Dedicated will serve as a catalyst for change across the industry.”
CE-Dedicated is the fourth in a series of BSI Speed-to-Market Programs designed for Class III medical devices requiring CE marking design dossier reviews. Programs include: CE-90 standard, which completes most reviews within 90 working days from submission; CE-45 FastTrack, expedited reviews within 45 working days; and CE-Onsite FastTrack in which BSI Product Experts conduct reviews at the customer’s premises targeted at 45 working days.
“By utilizing high-tech capabilities, we provide a dynamic and personalized information interchange over geographic distances that streamline the entire review process,” states Ron Rakos, Vascular Team Leader, BSI Healthcare.
CE-Dedicated is not designed for all products, such as ones containing medicines, animal or blood derivatives that require the use of outside agencies and may not be eligible. Although BSI cannot guarantee a positive recommendation, the CE-Dedicated review provides manufacturers the benefit of knowing where they stand sooner in the process and a progress report for briefing upper management. The complexity of the product, timelines and regulatory requirements impact which program is best suited to the client’s needs. BSI works with clients to determine the right fit for each product.
“BSI has tested the new CE-Dedicated program with some of our existing clients to glowing reviews,” said Ibim Tariah, Technical Director, BSI Healthcare. “Clients found it to be cost effective and appreciated the flexibility in the scheduling process. In addition, clients like the fact that BSI experts remain focused and dedicated over a specified number of days to ensure a high-quality, rapid review process.”