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We support the creation of instructions for use (IFU) in accordance with the requirements of MDR ANNEX I. Additionally, information provided by medical device manufacturers is required to be available in the official languages of the European Union (at least in English). We also support the English translation and native checking of technical documents required not only by ANNEX I but also by ANNEX II and ANNEX III, as well as DTP editing work. By pre-establishing related standards and translation memories, we provide high-quality translations with excellent cost performance in a timely manner. Furthermore, we also accommodate the production of accompanying e-learning videos. [Services] ■ Support for the creation of instructions for use (IFU) ■ Translation support ■ Support for e-learning video production *For more details, please refer to the PDF document or feel free to contact us.
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Free membership registrationAt Document House Group, we support the creation of instruction manuals for medical devices, compliance with standards, comparative analysis with other companies, English and multilingual translation, risk assessment from the user's perspective, and various licensing applications. For multilingual instruction manual creation, we offer a wide range of support in languages including English, Chinese (Simplified and Traditional), Korean, French, Italian, German, Spanish, Portuguese, and Russian. In our support for medical device licensing application processes, we assist with the preparation of various application forms, the establishment of QMS systems, and market research. Please feel free to consult us when needed. 【Service Overview】 ■ Support for compliance with standards for medical device instruction manuals ■ Support for creating multilingual instruction manuals ■ Support for medical device licensing application processes *For more details, please refer to the PDF materials or feel free to contact us.
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Free membership registrationProduct catalogs are a very important medium that influences the brand image of products and serve as promotional tools distributed to more clients and potential clients. It goes without saying that these catalogs are a significant factor in establishing your company's brand image. Therefore, if you are considering expanding your products overseas, localizing the product catalog is essential. However, arranging translation, DTP, and printing for each language can be a very challenging task. Document House Co., Ltd. not only produces catalogs but also handles everything from multilingual translation to printing in one comprehensive service.
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Free membership registrationIn manual production, our staff will coordinate the entire production process on your behalf, from planning, design, writing, DTP, translation, online manual production, printing, to delivery. We also handle the creation of technical illustrations from CAD data and photographs. Furthermore, we ensure compliance with various safety standards for manuals in the countries where products are shipped, including PL law measures (ANSI standard compliance), CE marking compliance, and SEMI standard compliance, in collaboration with legal experts. Upon request, we can conduct a product risk assessment from the perspective of the manual. Other achievements include e-learning systems, translation between English and Japanese, Japanese and Chinese (simplified and traditional), and English to multiple languages (French, Italian, German, Spanish, Russian, Chinese, Korean, and others).
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Free membership registrationTechnical translation offers high-quality translations by translators who are well-versed in various fields such as electronics, semiconductor manufacturing equipment, medical devices, and IT, supporting multiple languages including English. Translated content undergoes native checks in each language and, if necessary, is verified in the OS environment of that language. Additionally, we provide localization services tailored to your needs, ranging from the creation of multilingual pages for websites and online manuals to full localization of various systems.
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