ドキュメントハウス List of Products and Services

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 European official languages (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 memory, 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.

• Other services
• Other contract services
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At 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 licensing application documents, the establishment of QMS systems, and market research. Please feel free to consult us when you need our services. 【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 document or feel free to contact us.

• Other services

We support the necessary tasks for the production of various instructional materials related to medical devices (such as Instructions For Use [IFU] for healthcare professionals, patient manuals, maintenance manuals, package inserts, and other various files). We also offer translations that correspond to medical terminology, DTP services, and label creation in compliance with safety standards. In the medical field, we cover a wide range of medical devices, from home medical equipment (such as blood pressure monitors) to specialized devices like endoscopes and artificial hearts, which require specialized knowledge and higher safety standards. Risk Assessment of Medical Devices We support the risk management required for medical devices. We conduct risk assessments and risk analyses from the user's perspective and report the analysis results. For residual risks, we provide feedback to the design department as suggestions for safe design and protective design, and we will also consider reflecting these in manuals and labels.

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In manual production, our staff will coordinate the entire production process on your behalf, from planning, design, writing, DTP, translation, online manual creation, printing, to delivery. We also support the creation of technical illustrations from CAD data and photographs. Furthermore, we ensure compliance with various safety standards for manuals in accordance with the countries to which the 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 risk assessment of the product 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, etc.).

• Translation/Interpretation
• Catalog and manual creation
• Other services

Technical translation offers high-quality translations provided by translators who are well-versed in various fields such as electronics, semiconductor manufacturing equipment, medical devices, and IT, accommodating multiple languages including English. The translated content undergoes native checks in each language and, if necessary, is validated in the operating system environment of that language. Additionally, we support localization tailored to your needs, ranging from the creation of multilingual pages for websites and online manuals to full localization of various systems.

• Translation/Interpretation
• Catalog and manual creation

Product 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. At Document House Co., Ltd., we handle everything from catalog production to multilingual translation and printing all in one package.

• Catalog and manual creation
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This is a corporate risk assessment system available via the internet. It collects the results of individual risk assessments conducted by your company's personnel, providing total support for ERM tasks such as generating risk maps, ranking risks, and verifying countermeasures. ■ You can start comprehensive risk management (ERM) with the evaluation of basic risk items. ■ - We offer basic risk items related to overall corporate activities, including risks associated with business processes in accordance with the Companies Act and J-SOX, as well as disasters and compliance-related issues, making it easy for companies just starting with ERM to begin risk assessment. * For listed companies: [161 items], for unlisted companies: [142 items] - In higher versions, it is also possible to select and add risks tailored to your company's situation.

• Catalog and manual creation
• Other services
• others