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Tuesday, June 1, 2010

Interesting News and reports

-ISO 9004:2009 is released
-Planned ISO 50001 standard could help organizations manage energy consumption and reduce greenhouse gases.
-ISO/TS 16949:2009 Revision C is released
-AS9100 Revision C is released
-ISO 9000:2008 is released
-ISO 9001:2008 is released
-ISO 27001 replaces ISO 17799 as the new standard for IT security Information
-DaimlerChrysler Mandates ISO/TS 16949 to its suppliers.

CALISO has 100% success rate in helping customers reach their Time To Market and iso certification objectives. We are headquartered in Florida with a team of experts in high-tech industries, medical devices and low-tech industries and services.Contact us if you have any questions or need a quotation on a particular consulting or training service. Tel: 1-800-306-1366.

The FDA is making the process of obtaining 510ks a lot more difficult. The predicate-device process is coming under scrutiny for a lot of new devices, which were approved under the 510k system, even though they may share only a trivial similarity with a devices on the market. This new 510K approvalprocess will also have an impact on the CE certification process, which relies on notified bodies. They have to get aligned with the more stringent criteria for predicate medical devices.
Contact us by email or call us, should you need clarifications or help for 510K and new MDD and CE Mark implicatiions for your medical device(s) at 1-800-306-1366.


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