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.
Jumping the pond
29 Oct 2007
Topics: Medical devices, CE mark, USA
BSI Product Services Healthcare has just launched a 90-day CE marking programme, CE-90, aimed at giving healthcare customers faster access to the European market. CE marking offers medical device manufacturers worldwide an opportunity to break into the European market, which can be a challenge, especially with highly regulated products and services in areas such as healthcare and medical devices.
"BSI's target is to complete design dossier reviews in 90 working days or less," says Linda Vasquez, senior marketing manager, BSI Product Services Healthcare in USA. "BSI has assembled a team of full time medical device experts from industry so that we are fully resourced to meet and deliver device manufacturers' expectations for timely reviews."
The CE-90 programme has been developed especially for products needing design dossier reviews, detailed reviews of the technical file of a specific product. This includes Class III, highest risk devices, such as those in contact with the heart, brain, circulatory system or central nervous system, and often implantable.
For more information: www.bsigroup.com/oct07medicaldevices
Business Standards © 2007. 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.
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