Navigation Links
BSI Announces Global Launch of Clinical Strategy Review for CE Marking
Date:10/25/2010

BSI Announces Global Launch of Clinical Strategy Review for CE Marking -- RESTON, Virginia, October 25, 2010 /PRNewswire/ --


Advanced Search Search

  
Close
  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Biotechnology, Health Care & Hospitals, Medical Equipment, Medical Pharmaceuticals, New Products & Services Click to view news release full screen  

BSI Announces Global Launch of Clinical Strategy Review for CE Marking

   

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

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 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
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. China-Biotics, Inc. Announces Conference Call to Discuss First Quarter 2009 Financial Results
2. Odyssey Thera Announces Milestone Achievement in Pfizer Alliance
3. InNexus Biotechnology Announces Launch of Large Scale Primate Study of DXL625
4. Anesiva Announces Second Quarter 2008 Financial Results and Update
5. SGX Pharmaceuticals Announces Financial Results for the Three and Six Months Ended June 30, 2008
6. Insmed Announces Financial Results for Second Quarter and Six-Months Ended June 30, 2008
7. China Sky One Medical, Inc. Announces Conference Call to Discuss Second Quarter 2008 Results
8. China Yingxia International, Inc. Announces Conference Call to Discuss Second Quarter 2008 Results
9. ThirdBiotech Announces Kemeta as Newest Sponsor
10. Signalife Announces Intent to Withdraw From AMEX and Trade on the OTCBB
11. Chromos obtains interim order in connection with arrangement, announces annual and special meeting of shareholders and confirms mailing of information circular
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)...  Alex,s Lemonade Stand Foundation (ALSF), a leading national ... a state-of-the-art bioinformatics lab, using ,big data, to advance ... as Liz Scott , co-executive director of ALSF ... in Washington, D.C. , hosted by ... advocate of pediatric cancer research and awareness. ...
(Date:6/27/2016)... , June 27, 2016  Global demand for ... percent through 2020 to $7.2 billion.  This market ... beverages, cleaning products, biofuel production, animal feed, and ... diagnostics, and biocatalysts). Food and beverages will remain ... by increasing consumption of products containing enzymes in ...
(Date:6/27/2016)... /PRNewswire/ - BIOREM Inc. (TSX-V: BRM) ("Biorem" or "the Company") ... shareholders, Clean Technology Fund I, LP and Clean Technology ... based venture capital funds which together hold approximately 59% ... diluted, as converted basis), that they have entered into ... holdings in Biorem to TUS Holdings Co. Ltd. ("TUS") ...
(Date:6/27/2016)... DIEGO , June 27, 2016  Sequenom, Inc. ... committed to enabling healthier lives through the development of ... Court of the United States ... courts that the claims of Sequenom,s U.S. Patent No. ... patent eligibility criteria established by the Supreme Court,s Mayo ...
Breaking Biology Technology:
(Date:6/27/2016)... , June 27, 2016 Research and ... North America 2016-2020" report to their offering. ... North America to grow at a CAGR of ... been prepared based on an in-depth market analysis with inputs from ... prospects over the coming years. The report also includes a discussion ...
(Date:6/22/2016)... June 22, 2016  The American College of Medical Genetics ... Executive Magazine as one of the fastest-growing trade shows ... at the Bellagio in Las Vegas . ... percentage of growth in each of the following categories: net ... and number of attendees. The 2015 ACMG Annual Meeting was ...
(Date:6/22/2016)... ANGELES , June 22, 2016 /PRNewswire/ ... identity management and verification solutions, has partnered ... edge software solutions for Visitor Management, Self-Service ... provides products that add functional enhancements ... partnership provides corporations and venues with an ...
Breaking Biology News(10 mins):