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TUV USA is accredited by TUV NORD GROUP for EN ISO and MDD CE. Here we will provide links to important information and documents pertaining to these standards.

 

Please contact anyone from the TUV USA Medical Divison, if you should have any questions.

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Certifierat kvalitetsledningssystem enligt ISO 9001 - TÜV NORD

ISO 9001 Certificate

ISO 9001 is a quality management standard. It applies to all types of organizations no matter what size they are or what they do. It can help both product and service organizations achieve standards of quality that are recognized and respected throughout the world.
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ISO 27001 Certificate

The ISO 27001 standard was published in October 2005, essentially replacing the old BS7799-2 standard. It is the specification for an ISMS, an Information Security Management System. BS7799 itself was a long standing standard, first published in the nineties as a code of practice. As this matured, a second part emerged to cover management systems. It is this against which certification is granted. Today in excess of a thousand certificates are in place, across the world.
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ISO 13485

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.
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