BSI Announces Global Launch of Clinical Strategy Review for CE Marking

By Bsi Group, PRNE
Sunday, October 24, 2010

New Service Helps Device Manufacturers Ensure Clinical Evaluation Plans Meet Requirements Needed by the Notified Body

RESTON, Virginia, October 25, 2010 - BSI, a world class full-service Notified Body, announces its
global launch of the Clinical Strategy Review for manufacturers applying for
CE marking in order to place their medical device on the European market. The
new service helps manufacturers ensure ahead of time that their clinical
evaluation plan will be acceptable to meet the regulatory requirements needed
by the Notified Body. BSI debuts this service at the 2010 Regulatory Affairs
Professionals Society (RAPS) Annual Conference and Exhibition taking place
October 24 - 27, in San Jose, California.

Recent revisions to the European regulations now place an even
greater demand for thorough clinical evaluation as part of the technical
documentation. Many companies find producing supporting data to be
challenging, costly and very time-consuming. Nevertheless, the manufacturer
is solely responsible to demonstrate valid clinical evidence of product
safety and performance.

"Involving BSI sooner in the process, the manufacturer can gain a
clearer understanding of what the Notified Body expects and feel more
confident their data will be sufficient to meet the requirements," states
Paul Brooks, Vice President, BSI Healthcare.

"Ordinarily the manufacturer submits their clinical evaluation
plan at the end of the product development process as part of the full CE
marking technical document review," explains Gert Bos, Head of Regulatory and
Clinical Affairs, BSI Healthcare. "However, with our voluntary modular
approach, BSI can perform the review much earlier in the process; after the
plan has been finalized but prior to execution." It should be noted the BSI
Clinical Strategy Review is based on the manufacturer's successful
achievement of its clinical plan, the current legislation and related
guidance used at the time of the review which can change by the completion of
an investigation.

The highly trained BSI Team of Product Experts has extensive
experience in both regulatory and industry, working with large international
firms with diversified product portfolios to small start-ups with a single
medical device. As a Notified Body they successfully balance the requirement
to maintain objectivity and independence while providing practical feedback.
Companies large or small, obtaining clinical strategy agreement with their
Notified Body, will be seen in the market place as achieving a milestone on
the pathway to Europe.

"Having the clinical plan reviewed prior to execution reduces
risks of unexpected questions or surprises just prior to the planned launch,"
said Ibim Tariah, Technical Director, BSI Healthcare. "If concerns are
identified they can be addressed early and this places the company in a much
better position to meet their time-to-market goals."

For more information visit:

Notes to Editors

About BSI Group

BSI Group 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 2,500 staff operating in over 140 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

    - 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(R) 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

    - Supply chain security solutions which identify and mitigate
      risks in supply chains

    - Training services in support of standards implementation and
      business best practice.

BSI and Kitemark(R) were both voted UK Business Superbrands in
2010, by independent brand experts.

For further information please visit or

    Media Contacts:

    USA & Canada
    Linda Vasquez

    UK & Europe
    Claire Lynam
    Tel : +44-(0)8450-765600

Media Contacts: USA & Canada: Linda Vasquez, BSI, linda.vasquez at,, +1-(919)-359-0366. UK & Europe: Claire Lynam, BSI, Claire.lynam at,, Tel : +44-(0)8450-765600

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