Going Global With Multilingual Publishing (PART 1)

The great challenge of desktop publishing was always, besides the time and cost reductions and the maintenance of the graphic excellence of the traditional publishing processes, to develop techniques to allow changing the content without losing the whole work of accomplished formatting. It is called "processes optimization" -- a utopia for many, a goal for others.

Globalization resulted in increased need for immediacy of multilingual versions. Materials authored in one language need to be available in over 30 languages and it must be achieved in the shortest possible time at the lowest possible cost. It means that a small change in the product or service initiates an entire difficult and slow process of revision of all material with corresponding correction, re-format and re-print (or "re-publish", in the case of the electronic medias).

New technologies enabled separating the formatting information from the document content, which means documents can be reformatted easily. Also, Unicode support and OpenType fonts allowed inputting text in any language that is supported by the operating system. It is the necessary first step for multilingual publishing, but it does not constitute full language support. In other words, it does not mean that you can work with long documents, which are typographically correct in those languages.

Language support actually means several features need to be available within a DTP application. For most languages, this means at least hyphenation and spell checking dictionaries must be available. But language support can also include the ability to alphabetize lists correctly, such as table of contents and indexes, as well as the availability of additional import filters to handle language-specific characters or languages that need special composition treatment (double-byte and bi-directional languages for example).

Our future posts will cover some aspects and issues involved with working in multiple languages and future trends in publishing services as well. Stay tuned!

Excel Translations' quality assurance processes enable the company to meet and exceed the strict regulatory requirements and quality standards of its clients. The company's certification to and compliance with ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, EN 15038, and ASTM F 2575-06 acknowledge its long-standing commitment to excellence and its unwavering efforts to provide unparalleled quality to its customers. Contact us for more information about our medical translation services.

MDD 2007/47/EC- Final Thoughts on Translation Requirements As We Approach the Compliance Deadline

The deadline for manufacturers to mandatorily comply with MDD 2007/47/EC is finally here. As we all know by now, this is huge milestone which has been planned, reviewed, and adopted starting back in 2005. Now, with 5 years in the making, we are finally to the point where medical device manufacturers must comply or face losing their CE Mark as Directive 93/42/EEC is officially amended by 2007/47/EC on March 21, 2010.

There are quite a number of notable changes including the classification of software as a medical device and how this software should be validated. Within MDD 2007/47/EC, there are strict instances as to when software should be classified as a medical device and when it is not. Under Directive 2007/47/EC, because it amends Directive 93/42/EEC, when your software is classified as a medical device, it is subject to the same medical device requirements as under MDD 93/42/EEC.

These requirements include the language requirement of MDD 93/42/EEC under Article 4.4, Annex I, 13.3: “Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, Point 13, to be in their national language(s) or in another community language, when a device reaches the final user, regardless of whether it is for professional or other use.”

For medical devices covered under MDD 93/42/EEC, “information” includes such documentation as Indications For Use (IFU), operators’ manuals, installation manuals, packaging and labeling to name a few. Additionally, for software classified as a medical device under Directive 2007/47/EC, “information” includes GUI (Graphical User Interface), menus, dialog boxes, and error and status messages.

The important thing to remember here is that the explanation that users of the software have an understanding of English will not be acceptable. If the software is classified as a medical device, the user interface needs to be translated, no exceptions.

Additionally, independent of directive 2007/47/EC, software scripts should still be translated into a country’s official language per the Essential Requirements under MDD 93/42/EEC as detailed in a case study involving an industry-leading notified body. The case study can be downloaded here.

With mandatory compliance requirement coming on March 21, there has been a lot of discussion and opposing views. Make sure your software products are compliant to avoid any risk of losing your CE Mark.

Excel Translations' quality assurance processes enable the company to meet and exceed the strict regulatory requirements and quality standards of its clients. The company's certification to and compliance with ISO 9001:2008, ISO 13485:2003, ISO 14971:2007, EN 15038, and ASTM F 2575-06 acknowledge its long-standing commitment to excellence and its unwavering efforts to provide unparalleled quality to its customers. Contact us for more information about our medical translation services.