As medical science advances and technologies converge it is essential that a Notified Body can provide a full service to its clients. To this end BSI plans to broaden its medical device notified body offering to include In Vitro diagnostic medical devices (IVD) and has appointed Sue Spencer to lead this effort.
Sue will start on 1 September 2009. In this new position of Head of IVD, Sue will set up an expert, quick response fully accredited IVD Notified Body in BSI to serve IVD device manufacturers globally.
Sue Spencer has over 20 years experience in the IVD industry, where she held positions in R&D, Manufacturing, Compliance, Risk Management and Quality. Whilst in the IVD industry she worked for a range of manufacturers from small start ups to large multi nationals most recently Abbott Diagnostics. Sue already has Notified Body experience and worked as Technical and Operations Manager for a UK Notified Body during the introduction of both the Medical Device and IVD Directives. Therefore she has ideal experience and industry knowledge to help BSI add IVD’s to its Notified Body portfolio.
“Sue will be a brilliant addition to our Healthcare team,” said Neil Adams, Director, BSI Healthcare Operations and Delivery. “She brings unparalleled knowledge and experience of the IVD industry and its regulatory environment. This will benefit both BSI and IVD manufacturers greatly, and help us deliver a market leading IVD notified body service across the world.”
“I and the rest of the Healthcare team in BSI are very much looking forward to working with and learning from Sue”.
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About BSI British Standards
BSI British Standards is the UK’s National Standards Body, recognized globally for its independence, integrity and innovation in the production of standards and information products that promote and share best practice. BSI works with businesses, consumers and government to represent UK interests and to make sure that British, European and international standards are useful, relevant and authoritative. For further information please visit http://www.bsigroup.com/en/Standards-and-Publications/.
For further information please visit http://www.bsigroup.com/.
