News Release
Net-Translators earns ISO 13485:2003 certification for medical device industry
Or Yehuda, Israel, November, 15 2010 - Net-Translators, a leading provider of translation, localization, and multi-lingual testing services, today announced that it has achieved ISO 13485:2003 registration from the International Organization for Standardization. Net-Translators is one of the few language service providers (LSP) to achieve this level of certification.
Net-Translators offers a full suite of language services to medical device manufacturers to help them prepare all aspects of their products - software, technical and web materials, and more - for global use in compliance with relevant international regulations. By achieving ISO 13485:2003 certification, Net-Translators can guarantee medical device clients that their services are performed in compliance with the exceptionally rigid quality requirements set by this standard.
The primary objective of the ISO 13485:2003 standard is to facilitate a common set of global quality requirements for the medical device industry, in order to help medical device companies and their suppliers consistently meet the customer and regulatory requirements for quality. The ISO 13485:2003 certification specifies the necessary requirements for the quality management systems in these companies as they relate to the medical device industry.
"Receiving ISO 13485:2003 certification demonstrates to our medical devices customers that we are committed to the highest quality of service and to aligning our processes as needed to deliver localization services to this industry," said Gal Yissar, CEO, Net-Translators Ltd. "Although registration was a goal," Yissar added, "the benefits go well beyond passing a registration audit," adding, "any inspection and refinement of our already quality-focused processes will only serve to improve the quality of service we can provide to all of our clients."
ISO 13485:2003
The international standard in quality management for medical device manufacturing, ISO 13485:2003 is the most rigid global standard in manufacturing. The requirements for certification are based on a company’s ability to demonstrate compliance to standards by documentation, adherence to written processes, internal and external quality management, and material traceability record keeping.
About Net-Translators
Net-Translators is a leading provider of translation, localization, and multi-lingual testing services in over 60 languages to software, hardware, and medical device companies around the world. Services include translation, localization and robust multilingual testing of software products including GUIs and online Help, technical and marketing materials, websites, and games. Net-Translators specializes in translation of materials for compliance to international regulations. The company’s exclusive quality assurance center offers the ultimate testing environment for localized products of all kinds and includes a unique fully-equipped multi-lingual testing environment with professional
in-house linguists and technical support personnel. For more information, please visit www.net-translators.com.
Contact
Carine Illouz
+972-3-5387125
carine [at] net-translators [dot] com
