Support for compliance with medical device instruction manuals and creation of multilingual manuals! Please leave it to us.
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 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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【Service Details】 ■ Support for Compliance with Medical Device Instruction Manual Standards - IEC 60601-1 Ver3.0/Ver.3.1 - ISO 14971 - IEC 82079-1 - ISO 3864-2 - ANSI Z 535.6, etc. ■ Support for Creating Multilingual Instruction Manuals - English, Chinese (Simplified and Traditional), Korean, French, Italian, German, Spanish, Portuguese, Russian, etc. ■ Support for Medical Device Licensing Application Services - Assistance in preparing various licensing application documents - Support for establishing QMS systems - Support for clinical trial project management - Support for new entrants in the medical device field - Market research - Medical device consultation - Other various agency services *For more details, please refer to the PDF document or feel free to contact us.
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For more details, please refer to the PDF document or feel free to contact us.
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The content that governs communication encompasses a wide range of documents, including websites, company brochures, product catalogs, product manuals, and operational manuals. This not only shapes customers' impressions of products, services, and your company, but it is also not an exaggeration to say that it influences the value of the products themselves. While "attractive design," "clear expression," and "quick information searchability" are certainly important in the production of various types of content, we believe that addressing the risks inherent in communication is also a crucial element. Risks inherent in content: - Deterioration of the overall image of the product due to deficiencies in manuals - Lawsuits (product liability lawsuits) due to non-compliance - Occurrence of consumer complaints - Increased costs for support centers - Waste of advertising expenses, etc. For this reason, we offer a variety of services based on an element analysis approach and an effectiveness verification approach, responding to the complex and diverse needs of companies, from diagnosing communication risks inherent in corporate activities to planning, producing, and developing content, and subsequent verification.