BSI Expediting Expansion of In Vitro Diagnostic Scope for Medical Devices.The Addition of IVDs will Establish BSI BSI - British Standards Institute as a Full-Service Notified Body for All Medical Device Categories; Team Lead by IVD (Interactive VideoDisc) See interactive video. Industry Veteran Sue Spencer RESTON, Va. -- BSI, 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, 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 a full-service Notified Body supporting all types of devices, including medical, active implantable and IVDs. The In Vitro Diagnostics Directive (IVDD IVDD In-Vitro Diagnostic Device (medical) IVDD Intervertebral Disc Disease ) sets the requirements needed to place IVD devices on the European market. In vitro diagnostics includes all devices and kits used to test human samples in order to diagnose diagnose /di·ag·nose/ (di´ag-nos) to identify or recognize a disease. di·ag·nose v. 1. To distinguish or identify a disease by diagnosis. 2. a medical condition. As medical science advances and technologies converge con·verge v. con·verged, con·verg·ing, con·verg·es v.intr. 1. a. To tend toward or approach an intersecting point: lines that converge. b. , it is essential that a Notified Body can support clients across device categories. By extending its Notified Body service to include the IVD Directive, BSI will enable customers to work with one organization for all their regulatory needs, which will, in turn, enhance efficiency, predictability and speed-to-market. Sue Spencer has been tasked as head of IVD and will be responsible for setting up an expert, quick-response, fully accredited accredited recognition by an appropriate authority that the performance of a particular institution has satisfied a prestated set of criteria. accredited herds cattle herds which have achieved a low level of reactors to, e.g. IVD Notified Body to serve IVD device manufacturers globally. Spencer has 24 years of experience in the IVD industry working in R&D, manufacturing, compliance, risk management and quality for a range of large and small device manufacturers. She worked as a consultant for three years and set up her own consultancy before joining Abbott Diagnostics Division where she served as manager for International Quality Systems and Risk Management. In addition, Spencer has worked as a technical and operations manager See datacenter manager. for a UK Notified Body during the development of the IVD and Medical Device Directive. Spencer already has brought together a team of IVD experts with more than 60 years combined experience in the industry. These experts have worked on all aspects of the product life cycle, including R&D, manufacturing and quality. BSI will continue to add to its in-house IVD team of experts in the coming months, which will enable BSI to provide a fast, responsive service to customers. "I am thrilled to join BSI and lead the company's new IVD group," said Sue Spencer. "By bringing together an unmatched team of product and technology experts in house, BSI has demonstrated its commitment to the success of its IVD Notified Body and to meeting the demands of the IVD marketplace. The collaborative environment at BSI also ensures that as we encounter more complex devices that often cross device categories, we will be able to leverage experts at all levels of the organization and across Notified Body teams to deliver the highest quality, most efficient and effective reviews possible. As the medical device industry evolves, I am excited to be part of a team that is truly setting the standard." 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 * 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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