Moravia Achieves ISO 13485 Certification
Company’s Life Sciences Practice Demonstrates Commitment to Excellence
Brno, Czech Republic – January 10, 2013
Moravia, a worldwide leader in advanced translation and globalization solutions, has earned CSN EN ISO 13485 certification for its Life Sciences Practice.
This achievement represents a major commitment to excellence in Moravia's translation and globalization services as well as to the company's medical device and life sciences customers, according to Renato Beninatto, Moravia's Chief Marketing Officer.
ISO 13485 defines international standards for quality management and quality assurance within the design, development, production, installation and servicing of medical and in-vitro diagnostic devices. To market medical device equipment internationally, every piece must comply with each country's regulations, along with certain manufacturing standards.
"ISO 13485 certification complements our existing ISO 9001:2009 certification and reassures our clients that Moravia’s work meets or exceeds internationally recognized quality benchmarks in one of the most highly regulated industries in the world."
ISO 13485 also establishes standards for regulatory compliance, which is critical for medical device manufacturers. In most cases, regulatory compliance mandates that specific content, such as instructions, training, service manuals or software, be available in the native language of the device users in any given market. Moravia's Life Sciences unit provides documentation and content translation services for medical and in-vitro diagnostic equipment makers, as well as for the pharmaceutical and biotech industries.
Errors in translations—in addition to generating extra costs—may result in product delays, product recalls, and in some cases, can even lead to product liability lawsuits, Beninatto said.
"We hold our employees to the highest standards," he said. "ISO 13485 certification complements our existing ISO 9001:2009 certification and reassures our clients that Moravia’s work meets or exceeds internationally recognized quality benchmarks in one of the most highly regulated industries in the world."
Moravia is a leading globalization solution provider, enabling companies in the information technology, e-learning, and life sciences industries to enter global markets with high quality multilingual products. Moravia's solutions include localization, product testing, internationalization, multilingual publishing, technical translation, content creation, machine translation, and workflow consulting. Our dedicated testing and engineering solutions help companies succeed with their software and hardware products globally through services including test development, linguistic and functional testing, test automation and software engineering. Moravia Worldwide maintains global headquarters in the Czech Republic and North American headquarters in California, with local offices and production centers in Japan, China, Latin America, Ireland, USA and throughout Europe. To learn more, please visit www.moravia.com.
Europe & APAC
Libor Safar, Marketing Manager
libors (at) moravia.com
Renato Beninatto, Chief Marketing Officer
renatob (at) moravia.com
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