11 September 2009
BSI, the global standards and assessment body, has acquired German healthcare certification and testing business, EUROCAT. This development significantly enhances BSI’s ability to service the medical device market globally.
EUROCAT is an established Notified Body offering healthcare systems and product certification. The company has a significant presence in Germany - the third largest medical device market in the world – complementing BSI’s existing business there and strengthening its market presence within the European Union. EUROCAT also has a growing customer base in Russia and Turkey.
EUROCAT is accredited by all relevant bodies for the certification of medical devices, in-vitro diagnostics and active implantable devices, and is renowned for ensuring a high level of customer confidence in its services. Product testing and CE certification by EUROCAT allows the movement of medical devices into and within the EU. EUROCAT already assists medical device manufacturers with approval for the Russian market. Joining forces with BSI, EUROCAT can now also offer market access for medical devices to Canada, the US, Japan, Australia, Taiwan and Hong Kong.
Howard Kerr, CEO of BSI Group, said of the EUROCAT acquisition: “BSI is the leading Notified Body for medical devices in the UK and the US, so the take-over of EUROCAT is highly complementary. The acquisition opens up a wide range of exciting possibilities and establishes BSI as a key strategic partner for medical device and healthcare businesses in Europe and the US.”
BSI currently provides global certification of medical devices, giving clients wide ranging and effective market access with the supporting framework of BSI’s proven integrity in the standards, assessment and certification market.
The acquisition of EUROCAT significantly extends BSI’s scope as a Notified Body and also complements its existing global services in systems certification.
As part of the deal, EUROCAT founder, Werner Kexel, will join the BSI management team bringing with him 20 years experience in the medical devices industry.
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Notes to Editors
For media enquiries:
Public Relations Officer, BSI
Tel: +44 (0)20 8996 7248
Mob: +44 (0)7717 451 990
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 2,300 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 15 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
For further information on EUROCAT visit www.eurocat.de