CSOFT Helps Machinery Manufacturers Meet the Translation Requirements of the New EU Machinery Directives

September 17, 2009

Beijing, China – CSOFT International, Inc., a leading provider of multilingual localization, testing and outsourced software development for the global market, announced today that it is helping machinery manufacturers meet the new EU Machinery Directives BS EN ISO 13840-1 or BS EN 62061, requiring all user instructional materials to be translated into the target languages for the EU markets by 2012. The original deadline for compliance was December 31, 2009, however, it was extended to give more time to companies that had difficulties meeting the deadline requirement.

“We had been helping our clients translate their machinery manuals in time for the tight 2009 deadline, and this extension puts our customers just that much further ahead,” said Ms. Shunee Yee, President and CEO of CSOFT International.

Unlike past regulations with ambiguous definitions regarding what is considered a machine, the new EU Directives BS EN ISO 13840-1 or BS EN 62061 have broadened the definition of machinery to include any assembly fitted with a drive system that consists of linked parts and components, at least one of which moves. Further, the scope of the directive ranges from machinery itself to interchangeable parts, safety components, and even to chains and ropes that are a part of the assembly.

Past EU regulations only recommended that mechanical operating instructions be translated into local languages. However, the new EU Machinery Directives make the translation of all user instructions a mandatory requirement. Starting in 2012, all machinery, in addition to instructions in the original language, must also be accompanied by a translation of instructions in the language of the country in which the machinery is to be used.

This new requirement is in the best interests of machinery manufacturers, as it enables them to generate additional marketing exposure with local customers and reduce the incorrect use of their products—all important branding issues—leading to more sales and less money wasted on unnecessary customer support. Additionally, complying with these new directives will potentially reduce the likelihood of safety risks that result from unintentional misuse of machinery.

“While the updated compliance requirement brings important benefits to the machinery industry, it does put pressure on companies in terms of translation costs and time,” continued Yee. “This is especially true for companies that have not translated or have only translated a minimal portion of their user documentation in the past. Using state-of-the-art content management systems, multilingual terminology management tools and our professional in-country linguists, CSOFT’s translation process ensures that future product updates can leverage from existing translation efforts for better consistency and faster turnaround.”

As an ISO 9001:2008- and ISO 13485:2003-certified company, China-based CSOFT has been able to achieve the highest level of customer satisfaction by employing industry best practices and the global processes necessary to consistently improve translation service quality on a regular, quantifiable, and demonstrable basis.

CSOFT provides a broad range of language and technology solutions in over 90 languages across a variety of industries, including IT, Manufacturing, Life Sciences, Automotive and Financial Services. CSOFT has one of the largest technical resources in Asia with operations spanning the U.S., China, Japan, United Kingdom, Germany, Canada, the United Kingdom and Australia.

About CSOFT Health Sciences

CSOFT Health Sciences, leaders in clinical trial localization, provides AI/ML-enabled medical translation services for all phases of the drug and medical device product lifecycle, from development to post-launch. We also specialize in DCT solutions, linguistic validation, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of MMA, NDA, CTA, and Medical Device Application submissions. www.csoftintl.com

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