RESTON, Virginia, October 25, 2010 /PRNewswire/ -- 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: 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 email@example.com http://www.bsiamerica.com/healthcare +1-(919)-359-0366 UK & Europe Claire Lynam BSI Claire.firstname.lastname@example.org http://www.bsigroup.com/healthcare Tel : +44-(0)8450-765600
|SOURCE BSI Group|
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