TUV SUD America, a certification body for quality management systems, has granted ISO 13485:2003 certification to Idem Translations for translating life sciences materials.
Idem is involved in providing translation and localization services to medical device, biomedical, and pharmaceutical industries as well as to contract research organizations, healthcare research centers and institutional review boards.
Idem said, in addition to ISO 13485:2003, the company has achieved international standards of ISO 9001:2008 and EN15038:2006 for its quality management system.
Idem Translations president Mariam Nayiny said the certification demonstrates the company’s understanding of the regulatory environment and distinguishes it from other language service providers.
"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," Nayiny added.