European medical device market 2011

Europeans are left to their own devices | BMJ

- Reprinted from CSA Group websites

Hong Kong, Aug. 1, 2013 / PRNewswire PRNewswire / - the world's leading testing and certification organization CSA Group companies with commercial standards BSI formed a strategic alliance for the electronic medical device industry (e-health) provide customers access to global markets solutions. Through the alliance, CSA Group will be based on relevant electronic standards for electronic medical product safety and performance to provide certification and testing. BSI will provide different regions of the world, including the European CE certification of conformity assessment and undertake international standard ISO 13485 (Medical Devices Quality Management System) certification.
CSA Group Vice President, Magali Depras European subsidiary, said: "By reaching this strategic alliance, CSA and BSI Group launched a single point of contact for customer service, to provide one-stop diverse electronic medical equipment certification and we will is needed in different medical electronics markets diverse certified global manufacturer providing integrated, economical business solutions. "
Products include electronic medical patient monitoring equipment, anesthesia and respiratory equipment, surgical equipment used, and large medical imaging equipment. According to the German trade organization ZVEI (Note 1) data, in 2010, a single electronic medical products in the German domestic market value of up to 1.15 billion euros.
BSI Medical Technical Director Gary Slack said: "The electronic medical devices to market is a very complex process, and our integrated service advantages will help manufacturers to improve the efficiency of the process. BSI, CSA Group's technical expertise global depth and breadth will provide access to existing and future customers in Europe, Asia and North America markets pipeline. "
The alliance will provide electronic medical device manufacturers to obtain CE certification to provide a faster, more predictable way. CSA Group and BSI for customers who, in view of BSI and CSA Group in the European Union and the North American market has a wealth of expertise and cooperation between the two will be better able to help customers meet local and regional requirements, thereby enhancing the global market enter capability.
In addition to strategic alliances within the organization, CSA and the acquisition of the German company BSI testing business (formerly known as BSI / EUROCAT part) to provide the International Electrotechnical Commission (IEC) and IEC standards carried out on electronic medical equipment testing services.
Depras lady said: "Through the acquisition of these assets in order to increase our presence in Frankfurt electronic medical device testing and certification capabilities, so as to carry out global electronic medical business customers in Germany and Europe, localized testing and certification services, which reflects our commitment to uphold our customers. "
CSA Group will immediately obtain BSI electronic medical device testing business ownership. To not affect customer service and existing contracts, CSA Group will lease BSI facility in Frankfurt, Frankfurt until early 2014 a new laboratory built so far. BSI CSA promised to retain existing staff skills, expertise and knowledge.
A German electronic medical industry, trade and investment in Germany, August 2011
About CSA Group
CSA Group is an independent non-profit membership Association dedicated to promoting security, social welfare and sustainable development. Group has the knowledge and expertise, including industry-standard development; training and counseling programs; in key business areas globally recognized testing and certification services, such as dangerous places and industrial areas, sanitary and construction, medical, safety and technology, electrical and gas, alternative energy, lighting and sustainable programs; and consumer evaluation services. Hundreds of billions of the world's products are affixed with CSA certification mark. For more information about the Group, please visit .
About BSI

Подробная информация laina 50000 тут.
Directory of the European Medical Device & Biomaterials Industry
Book (Elsevier Science Pub Co)
2006-04-15 20:34:56 by merrimac

No it doesn't there is accurate non Lab versions

Cholestech LDX System, which carries the CE Mark for marketing of medical devices in the European Union, has been certified
by the United States Cholesterol Reference Method Laboratory Network (CRMLN), which validates that the system meets the gold standard for accuracy and reproducibility developed by the Centers for Disease Control and Prevention (CDC) for the measurement of total cholesterol and HDL cholesterol consistent with National Cholesterol Education Program (NCEP) analytical goals. The NCEP recommends that everyone over the age of 20, or more than 200 million Americans, should be screened for cholesterol.

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