ISO 13485:2003 is a standard that applies specifically to the medical device industry and is a complement to ISO 9001:2008, to which ForeignExchange is also certified. Though ISO 13485 focuses on the quality systems of medical device companies, it is also applicable to their suppliers. Certification assures that sub- suppliers are holding quality requirements to the same high level as the device companies themselves. As a service provider to many top medical device companies, ForeignExchange recognizes the importance of accurate translations to the overall quality of its clients’ products.
Sonia Monahan, Executive Vice President of Quality at ForeignExchange commented, “Given our 100% focus on medical translations, it only made sense for us to seek ISO 13485 certification. Our medical device clients have known about our world class quality system. It was time to make it official and this certification affirms our commitment to excellence.”
ForeignExchange achieves ISO 13485:2003 certification
About ForeignExchange Translations
ForeignExchange Translations, Inc. is redefining the delivery of foreign-language services to the medical device, biotechnology, and pharmaceutical industries. ForeignExchange's solutions are based on its proprietary Multilingual Compliance Process, combining expert linguists, best-of-breed technology, and measurable translation quality in a robust and scalable process that can be deployed in multiple languages simultaneously. ForeignExchange provides Internet globalization, software localization, and technical translation solutions to clients such as Abbott (NYSE:ABT), Pfizer (NYSE:PFE), GlaxoSmithKline (NYSE:GSK), Baxter (NYSE:BAX), and Medtronic (NYSE:MDT). For more information, please visit www.fxtrans.com.
