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CSOFT Earns ISO 13485:2003 Certification for Medical Device Industry
Date:3/31/2009

Certification Confirms MedL10N Division's Commitment to Quality

Beijing, China (PRWEB) March 31, 2009 -- CSOFT International Ltd., a leading provider of multilingual localization, testing and outsourced software development for the global market, announced today that it has achieved the International Organization for Standardization's (ISO) 13485:2003 certification. This ISO certification specifies the necessary requirements for an organization's quality management system as it relates to the medical device industry. CSOFT is one of the first language service providers (LSP) to be awarded this prestigious certification. CSOFT's MedL10N division provides a complete range of localization, internationalization, and globalization services for the medical device field.

"At CSOFT, we have always insisted on implementing industry best practices and proven processes consistent with the highest quality standards in our localization production to meet the stringent quality requirements of our medical device and life sciences clients," said Shunee Yee, CSOFT President and CEO. "Being awarded ISO 13285:2003 certification further validates the depth and maturity of our quality management system (QMS) for medical translation and continuous improvement."

The ISO 13485:2003 standard was specifically developed to help medical device companies meet customer and regulatory requirements by consistently delivering products and services with the highest quality.

CSOFT's ISO 13485:2003 audit was performed by the BSI Group, the world's premiere quality management systems registrar. BSI conducted an exhaustive on-site audit to verify that CSOFT's quality management system fully conforms to the requirements of the ISO 13485:2003 standard.

"The primary objective of this ISO 13485:2003 certification is to facilitate harmonized medical device regulatory requireme
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Source: PRWeb
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