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BSI

FDA Compliance

Product News: BSI Launches New CE-Dedicated FastTrack Program

Company expands CE-marking product line, helps boost speed to market for medical devices.

Published: Monday, September 14, 2009 - 14:08

(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.

“We listened to our customers and have expanded the toolbox to offer different solutions to fit specific customer requirements,” says Paul Brooks, vice president of 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,” says Ron Rakos, vascular team leader of 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. 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 determine which program is best suited to the client’s needs. BSI works with clients to decide the right fit for each product.

“BSI has tested the new CE-Dedicated program with some of our existing clients to glowing reviews,” says 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.”

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BSI

BSI (British Standards Institution) works with more than 80,000 clients in 172 countries to help them adopt and cultivate the habits of excellence. Clients are trained and provided with practical guidance for implementation alongside a suite of compliance tools. BSI is assessed and accredited by more than 26 accreditation bodies including ANSI-ASQ National Accreditation Board (ANAB) and United Kingdom Accreditation Service (UKAS). BSI’s influence plays a key role within the International Organization for Standardization (ISO). As one of the founding members, it ensures that international standards address business and societal needs, while delivering real benefits to organizations.