molecular genetic analyses

ATLAS Biolabs fulfills requirements of DIN EN ISO 13485:2003 + AC:2009 standard for development and manufacturing medical devices

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Berlin, May 11, 2011 – By gaining certification according to the internationally recognized quality standard DIN EN ISO 13485 + AC:2009, ATLAS Biolabs GmbH has reached another milestone in its advances in the field of molecular diagnostics. DIN EN ISO 13485 + AC:2009 provides the criteria for quality management in the design and manufacture of medical devices; and compliance with this standard is required in order to develop and distribute software that falls within the scope of the European directive 98/79/EC for in vitro diagnostics. The new certificate gives the company a stronger position in molecular diagnostics and makes it an ideal partner for other companies that are looking to develop or have developed in vitro diagnostic tools. ATLAS Biolabs has been certified according to DIN EN ISO 9001 since 2008.

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DIN EN ISO 9001:2008 blank EN ISO 13485
ISO 9001 service at ATLAS Biolabs is always oriented along internal quality rules which guarantee a constant quality of our work.
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