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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Notes to Editors
BSI is a 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 many 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.bsigroup.com
Contact: Claire Lynam, Head of Global Marketing Communications,
BSI. Tel: 08450 765600, firstname.lastname@example.org