By meeting the same rigorous requirements to which our medical device clientele adhere, we are uniquely able to manage risk and maintain effective processes for their benefit.
Palo Alto, California (PRWEB) January 24, 2013
Idem Translations, Inc., a full-service provider of translation and localization services, has achieved ISO 13485:2003 certification from TÜV SÜD America Inc., a worldwide certification body for quality management systems. The company’s quality management system is additionally certified to the ISO 9001:2008 and EN15038:2006 international standards.
This achievement makes Idem Translations one of a select group of language service providers to hold all three industry certifications for the translation of life sciences materials.
ISO 13485:2003 is a globally recognized standard developed by the International Organization for Standardization (ISO) that specifies the requirements for quality management systems (QMS) in the medical device industry. In order to be certified to the ISO 13485:2003 standard, companies must demonstrate the implementation, maintenance, and effectiveness of a medical device QMS that identifies, manages, and minimizes risks associated with the manufacturing of medical devices and related services.
Idem provides expert translations of all types of documentation related to research and development, clinical trials, FDA and CE Mark submissions, international marketing, and ongoing patient care.
“ISO 13485:2003 distinguishes Idem from other language service providers because it demonstrates our understanding of the regulatory environment in which our clients operate,” said Mariam Nayiny, president of Idem Translations, Inc. “By meeting the same rigorous requirements to which our medical device clientele adhere, we are uniquely able to manage risk and maintain effective processes for their benefit.”
“Achieving ISO 13485:2003 certification exhibits Idem’s commitment to quality,” said Craig Casillas, vice president, Management Services, TÜV SÜD America Inc. “It demonstrates companywide dedication and teamwork to continually monitor quality and consistently follow well-organized processes.”
About TÜV SÜD America Inc.
TÜV SÜD's Auditing Division provides management system certification services to ISO 50001, ISO 9001, ISO 14001, AS9100, AS9120, ISO 13485, TL 9000, Safe Quality Food (SQF), ISO 22000, and more. TÜV SÜD's Testing Division offers Electrical and Mechanical Product Safety, Electromagnetic Compatibility (EMC) testing, Environmental Testing, NRTL and SCC certification, CE Marking assistance, Restricted Substance Services, International Compliance Services and more. The company's Industry Division offers a full suite of services for pressure equipment manufacturers and materials producers exporting products to the European Community. Globally, TÜV SÜD has 17,000 employees that are represented at more than 800 locations throughout the world. Optimizing technology, systems, and know-how, the interdisciplinary specialist teams act as process partners to strengthen their customers' competitiveness.
About Idem Translations, Inc.
Founded in 1983, Idem Translations, Inc. is a full-service provider of translation and localization services. Idem specializes in certified translations for medical device, biomedical, and pharmaceutical companies, as well as other organizations and entities working in the life sciences sector, such as contract research organizations (CROs), healthcare research centers, and institutional review boards (IRBs). The company is a WBENC-certified woman-owned business and holds certifications to ISO 9001:2008, ISO 13485:2003, and EN 15038:2006.