BSI Launches New CE-Dedicated FastTrack Program at RAPS Conference.Company Expands CE-Marking Product Line, Helps Boost Speed-to-Market for Medical Devices RESTON, Va. & PHILADELPHIA -- BSI BSI - British Standards Institute , a world-class Notified Body providing regulatory and quality management reviews and product certification Product certification or product qualification is the process of certifying that a certain product has passed performance and/or quality assurance tests or qualification requirements stipulated in regulations such as a building code and nationally accredited test standards, 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 Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: RAPS Ram Air Performance System RAPS Regional Air Pollution Study RAPS Ram-Air Progression System (skydiving training) RAPS Ram Air Parachute System RAPS Retired Army Personnel System ) 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 ded·i·cate tr.v. ded·i·cat·ed, ded·i·cat·ing, ded·i·cates 1. To set apart for a deity or for religious purposes; consecrate. 2. 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 See toolkit and toolbar. 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 per·son·al·ize tr.v. per·son·al·ized, per·son·al·iz·ing, per·son·al·iz·es 1. To take (a general remark or characterization) in a personal manner. 2. To attribute human or personal qualities to; personify. information interchange An interchange is a location where two things meet, usually perform some kind of exchange, and possibly go on their ways again. It is most commonly used in four contexts:
1. pertaining to vessels, particularly blood vessels. 2. indicative of a copious blood supply. vas·cu·lar adj. Team Leader, BSI Healthcare. CE-Dedicated is not designed for all products, such as ones containing medicines, animal or blood derivatives derivatives In finance, contracts whose value is derived from another asset, which can include stocks, bonds, currencies, interest rates, commodities, and related indexes. Purchasers of derivatives are essentially wagering on the future performance of that asset. 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 Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. 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." About BSI BSI is global independent business services organization that inspires confidence and delivers assurance to over 80,000 customers with standards-based solutions. Originating as the world's first national standards body, BSI has over 2,400 staff operating in over 120 countries through more than 50 global offices. BSI's key offerings are: * The development and sale of private, national and international standards and supporting information that promote and share best practice * Second and third-party management systems assessment and certification in all critical areas of management disciplines * Testing and certification of services and products for Kitemark and CE marking to UK, European and International standards. BSI is a Notified Body for 17 New Approach EU Directives (European Union Directive) A set of privacy requirements that took effect in 1998 and ordered European member nations to enact compliant legislation. It deals with the establishment of Data Protection Authorities, people's rights to personal information and enforcement. * Certification of high-risk, complex medical devices * Performance management software solutions * Training services in support of standards implementation and business best practice. For further information, please visit www.bsiamerica.com/healthcare. |
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