CSOFT Earns ISO 13485:2003 Certification for Medical Device Industry

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Certification Confirms MedL10N Division's Commitment to Quality

After our audit, it became clear that CSOFT is committed to creating and implementing an effective QMS in delivering localization services to the medical devices industry.

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 requirements for quality management systems," said Lane Ji, the Lead Assessor from the BSI Group. "After our audit, it became clear that CSOFT is committed to creating and implementing an effective QMS in delivering localization services to the medical devices industry."

CSOFT provides a broad range of language and technology solutions in over 90 languages for a variety of industries such as IT, life sciences, manufacturing, automotive, and financial services. CSOFT has one of the largest technical resources in Asia with a global network of operations spanning the United States, Japan, Germany, Canada and Australia as well as language teams in all major European and Asian markets. This unique background allows CSOFT to create long-term cost efficiencies through streamlined L10N processes, fast turnaround, and consistent, quality execution at every step of the localization cycle.

For more information about CSOFT, please visit: http://www.csoftintl.com. For more information about MedL10N, CSOFT's life sciences division, please go to: http://www.medL10N.com. Media inquiries should be directed to elena.mccoy (at) csoftintl (dot) com or +1.415.462.5674.

About CSOFT
CSOFT International Ltd., is a leading provider of multilingual localization, testing and outsourced software development for the worldwide market. Powered by our expert in-country linguistic resources, CSOFT delivers language translation/technology solutions into 90+ languages. CSOFT services a variety of industries such as information technology, manufacturing, life sciences, financial services, chemical and energy. Using industry best practices and processes, CSOFT streamlines translation and localization for software, product manuals, online help, marketing collaterals and website content, and offers multilingual publishing for virtually all formats.

About MedL10N
MedL10N is a division of CSOFT International Ltd., focusing on the delivery of end-to-end multilingual localization and testing solutions for the life sciences industry. MedL10N has extensive experience helping pharmaceutical, medical device and biotech companies in their globalization requirements in research and development, as well as regulatory and marketing support. Our experienced in-country linguistic experts, many of whom hold advanced degrees, are specially trained in the medical disciplines to overcome the globalization challenge of the life sciences industry. By focusing on the unique requirements of medical fields, and combined with L10N industry best practice, innovative technologies, and client-focused solutions, MedL10N helps our clients deploy products and services in global markets faster and with better quality.
About BSI Management Systems

BSI Management Systems is one of the world's largest certification bodies, with over 64,000 certified locations and clients in more than 120 countries. Operating through a global network, BSI Management Systems provides assessment, certification and training services in all critical areas of management disciplines including:

  • Business Continuity
  • Environment
  • Food Safety
  • Health & Safety
  • Information Security
  • Integrated Management
  • Quality
  • Social Accountability
  • Sustainable Development
  • IT Service Management.

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Elena McCoy
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