SCIENION US, Inc has announced that its entire portfolio of microarray services is now manufactured under ISO 13485 certification, an internationally recognized standard for quality management systems (QMS). The certification is accredited by TÜV SÜD America Inc.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
"SCIENION had already earned a global reputation for producing very high quality spots, always emphasizing quality in every step of our manufacturing process. Today, we're very pleased to be adding the external validation of our ISO 13485-compliant Quality Management System," said Dr. Claude Dufresne, SCIENION US, Inc President and Chief Business Officer.
"As the leading provider of microarray-based services for a wide variety of applications, we remain committed to our customers in providing the highest quality of products and services in this market," said Holger Eickhoff, SCIENION CEO. "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’s microarray services at the SCIENION AG facilities have been manufactured in compliance with the ISO 9001:2008 standard since December 2008.