BSI Announces Global Launch of Clinical Strategy Review for CE Marking
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
in
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
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
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
“Having the clinical plan reviewed prior to execution reduces risks of
unexpected questions or surprises just prior to the planned launch,” said
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: http://www.bsiamerica.com/clinical
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
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(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 http://www.bsigroup.com or
http://www.Kitemark.com
Media Contacts:
USA & Canada
Linda Vasquez
BSI
linda.vasquez@bsigroup.com
http://www.bsiamerica.com/healthcare
+1-(919)-359-0366
UK & Europe
Claire Lynam
BSI
Claire.lynam@bsigroup.com
http://www.bsigroup.com/healthcare
Tel : +44-(0)8450-765600
SOURCE BSI Group