BUSINESS STANDARDS
is the quarterly magazine of BSI Group, highlighting the vital role that standards play in today's business environment. Regular features include interviews with leading business figures, as well as news on the latest developments in management systems and standards.
The fast track to CE Marking
06 Feb 2009
Topics: Healthcare, CE mark
The new programme, named CE-45, aims to speed up the review process, with most reviews completed in 45 working days for medical devices headed to European markets. The new programme builds on a similar scheme launched last year called CE-90, in which dossier reviews are finished within 90 working days. BSI is committed to providing programs that combine speed and predictability with experience, integrity, independence and reliability.
"There are many Notified Bodies, but the design dossier review process is not always clear and transparent to the medical device manufacturer," says Paul Brooks, vice-president and country manager of BSI Product Services Healthcare. "In the final step of the launch, CE Marking is the only thing standing between the manufacturer and access to over 400 million citizens in the European market. It is a critical part of launching their product in Europe. They want the process to be predictable, thorough and fast as possible."
While BSI cannot guarantee a CE Marking certificate in 45 or 90 days, the goal is to complete the review process with either a positive or negative recommendation. Some products require the use of outside agencies, such as medicinal, blood or animal tissue products, so they may not be eligible for these programmes.
"We can ensure open communication with our customers and dynamic feedback to help them meet their goals, but we do not cut any corners or promise anything we cannot deliver," adds Brooks.
Keeping the pace
BSI created the New CE-45 FastTrack programme for when every moment counts in the final phase of getting medical devices to European markets, Brooks explains. CE-45 provides:
>CE Marking for medical devices;>completed reviews in 45 working days;
>knowledgeable product experts;
>dynamic, two-way communication; and
>a technically advanced environment.
Brooks notes that BSI has recruited experts from the industry to help implement this new service.
"We have been listening to our customers," he says. "We have been hearing what their problems, issues and expectations are, and these two services are a direct result of that. CE-90 was the first step to make the process more predictable and more transparent for medical device manufacturers. CE-45 is the next initiative, but it is not the end of the story by any means. We are working on many other initiatives that put BSI's customers at the centre of what we do.
"We understand their needs; we understand what they require from a Notified Body and we are delivering that in the hopes of exceeding those expectations."
Visit the BSI Speed-to-Market web page at: www.bsiamerica.com/Speed-to-MarketPrograms
Business Standards © 2009. Editorial produced by Caspian Publishing in association with the British Standards Institution. Editorial opinions expressed on are not necessarily those of BSI Group or Caspian Publishing. Neither Caspian Publishing nor BSI Group accept responsibility for advertising or editorial content, nor for that appearing on linked third-party websites. Reproduction in whole or in part is forbidden without written permission from BSI Group or Caspian Publishing.
BSI is planning an informal free lunchtime roundtable in central London on 10 December 2009 to explore how small businesses and their trade bodies can work more effectively with standards. Places are limited so to register your interest or request more information, please email bsi.survey@bsigroup.com or call +44 (0)20 8996 7750.
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Question: What impact do you think BCM could have on business insurance in the future?
It is essential that any business suffering a disaster is able to continue as near normal trading in the shortest possible time period to survive. To achieve this, an organization should implement a comprehensive well-tested business continuity plan (BCP) as a first step. Insurance should be viewed as an extension to the BCP process, not an alternative.
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