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Scienion Receives ISO Certification, Mar 18, 2015

NEW YORK (GenomeWeb) – Scienion US today said that its portfolio of microarray services is now manufactured under ISO 13485 certification. 

The certification is accredited by TÜV SÜD America. Scienion's microarray services at theBerlinfacilities have been manufactured in compliance with the ISO 9001:2008 standard since 2008, the company said. 

ISO 13485:2003 covers a quality management system, and an organization is required to demonstrate it has ability to provide medical devices and related services that meet customer and regulatory requirements. 

"We believe that Scienion is now in a stronger position to take the next step with our customers pursuing regulatory clearance of microarray-based testing platforms in the diagnostics market," Scienion CEO Holger Eickhoff said in a statement.

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