Navigation Links
New BSI CE-Onsite Facilitates CE Marking Reviews for Device Manufacturers
Date:3/26/2009

RESTON, Va., March 26 /PRNewswire/ -- As a direct response from client feedback, BSI launches a new speed-to-market program, CE-Onsite FastTrack Review, for Class III medical devices needing European CE Marking Design Dossier Reviews. This new program will expedite the review process through live, onsite interaction, facilitating more efficient communication as well as the goal of completing the review in 45 working days.

The CE-Onsite has the same features of the CE-45 FastTrack Program, with one main difference: BSI Product Experts visit the manufacturer's premises to perform the review. As an industry norm, reviews are conducted via mail, email, fax and telephone and the process can take months. However, performing reviews onsite allows for a much faster timeline while still maintaining the same high quality. This face-to-face opportunity provides Product Experts accessibility to all relevant parties, from engineers to regulators, and supports dynamic communication, immediate access to documentation and in-person viewing of the new product.

This new premium program is not for everyone or every product. As with the CE-90 and CE-45 programs, some products such as medicinal, blood and animal tissue products, require the use of outside agencies and may not be eligible for CE-Onsite Review. In addition, while BSI's goal is to complete the review with either a positive or negative recommendation within 45 working days, the length of the review greatly depends on the degree to which the manufacturer is prepared. In order to make the review as effective as possible, clients should have a strong motivation to get their product to market and excellent documentation, and be well-organized and responsive to questions. Manufacturers utilizing the CE-Onsite have experienced numerous advantages including shorter launch times, patients gaining access to new technology sooner and quicker return on investment.

"The interactive aspect of the CE-Onsite FastTrack Review compresses the review time, improves the predictability of the review's outcome, and promotes a faster time-to-market," stated Ibim Tariah, Technical Director of BSI, Healthcare. "BSI provides thorough and fair reviews that focus on what really matters, but we never guarantee a CE Marking," Tariah added. "The integrity of each review is critical to ensuring a medical device is deemed safe for its intended use."

BSI focuses on the changing marketplace and responds to arising issues with solutions that help organizations achieve their goals and objectives. We employ top-notch Product Experts who are well-trained, experienced, and knowledgeable in their respective fields. They understand the medical device industry and the challenges medical device manufacturers face in today's competitive environment.

About BSI Product Services, Healthcare

BSI Product Services, Healthcare contributes to our clients' success in the global medical device industry by accelerating access to international markets. We are a world-class Notified Body, dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers. BSI has been conducting business in more than 100 countries for over 100 years. Our experienced healthcare team specializes in high-risk, invasive, combination and implantable products. BSI services include CE Marking, ISO 13485, CMDCAS, Japan PAL, FDA Accredited Persons Inspections, Standards and Training. We are committed to providing programs that combine speed with experience, integrity, independence and predictability.

    Media Contact:
    Linda Vasquez
    linda.vasquez@bsigroup.com


'/>"/>
SOURCE BSI
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Brotman Medical Center Facilitates Restructuring Through Chapter 11 Filing
2. Optimal band imaging with endoscopy facilitates the diagnosis of depressed-type early gastric cancer
3. Interview by Internet Can Decrease Greatest End-of-Life Fears: It Facilitates Creating Effective Advance Directives, Living Wills
4. Misys Facilitates Masraf Al Rayans Expansion of Islamic Banking Operations
5. ACS Facilitates Emergency Prescription Assistance Program Now Activated in Southern Louisiana
6. TeleHealth Services TIGR(R) Interactive Patient Education System Facilitates Award-Winning Results at Northridge Hospital Medical Center
7. Chamberlain Group Surgical Training Model Facilitates New Treatment for Chronic Rhinosinusitis
8. The Integrated Benefits Institute Offers Largest Benchmarking Database in U.S. Spanning Disability and Workers Compensation Programs
9. BeneChills RhinoChill System Receives CE Marking for European Commercial Sale
10. ANSYS Expands HPC Benchmarking Program
11. Global Benchmarking Council Launches New Virtual Tour of Research & Networking Service
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... ... March 23, 2017 , ... ... today announced rapid completion of the strategic executive team expansion needed to further ... to the ChenMed executive team,” says Christopher Chen, MD, ChenMed Chief Executive Officer. ...
(Date:3/23/2017)... ... ... Inflow IQ & Inflownomics of Raleigh, NC introduce a powerful information access network. ... experts in dangerous situations the Inflow IQ team can help people. Get ready ... & refreshing knowledge systems that enhance life. , Authentically enjoy 500 ...
(Date:3/23/2017)... ... March 23, 2017 , ... On 2 March ... the US Special Operations Command’s Patriot Award. The award was presented by the ... Force Dagger Foundation for its significant and enduring support to the command. ...
(Date:3/23/2017)... ... March 23, 2017 , ... “Beyond and Back”: a true-life testimony ... the creation of published author Bonetta Rose, a wife, mother and grandmother committed to ... by Christian Faith Publishing, Bonetta Rose‘s new book presents actual events in the life ...
(Date:3/23/2017)... ... ... Trainer”: an electrifying and suspenseful gunslinger novel with a twist. “The Trainer” is ... an enthusiasm for action and adventure stories. , Published by Christian Faith ... at the thirty-three notches that lined the edges of the wooden grip plates of ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... , March 23, 2017 /PRNewswire/ - INVICTUS MD ... IVITF; FRA: 8IS) Invictus MD announces that AB Laboratories ... in its licensed production facility under the Access to ... Hamilton, Ontario . The ... in October 2016, is currently operating at half capacity, ...
(Date:3/23/2017)... 23, 2017 Piramal Pharma ... anuncia el nombramiento de Stuart E. Needleman ... de servicios integrados completa para su base de ... clave en el crecimiento y ejecución de las ... de impulsar todas las actividades de desarrollo empresarial ...
(Date:3/23/2017)... TEL AVIV, Israel, March 23, 2017  Galmed ... or the "Company"), a clinical-stage biopharmaceutical company focused ... for the treatment of nonalcoholic steatohepatitis, or NASH, ... for the three and twelve months ended December 31, ... recently completed pre-clinical studies demonstrating Aramchol™,s potential direct ...
Breaking Medicine Technology: