Medical Device Instruction Manual Production and Translation Services
Medical Device Instruction Manual Production and Translation Services
We accept the production and translation of medical device manuals (manuals for healthcare professionals [IFU], patient manuals, maintenance manuals, package inserts, etc.).
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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Manual Standard Compliance Evaluation We provide services for standard compliance evaluation in the medical field, starting with the IEC 60601-1 series. Upon request, we investigate and analyze the relevant standards for the product's shipping country and various medical fields, and we also conduct manual standard compliance evaluations. Additionally, we support the transition from the MDD (Medical Device Directive) to the MDR (Medical Device Regulation) in the EU, assisting with the new requirements for medical device instructions for use (IFU, labeling, etc.). Medical Translation We offer high-quality translations provided by translators well-versed in the medical field. In addition to Japanese-to-English and English-to-Japanese translations, our translators are equipped to handle multilingual translations with expertise in the medical sector. We support the creation of English versions of related documents newly required by the MDR. In the translation process for these English versions, we achieve appropriate medical translations by database organizing key medical-related standards and the general names of medical devices (JMDN). During translation, we can also accommodate the database organization of individual standards specific to your product area, so please feel free to consult with us.
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Due to confidentiality agreements, we cannot disclose your company's name, but we are engaged in transactions with manufacturers in various fields such as home appliances, various manufacturing equipment, engineering devices, and medical devices.
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The content that governs communication encompasses all types of documents, including websites, company brochures, product catalogs, product manuals, and operational manuals. This not only shapes customers' impressions of your products, services, and company but also significantly influences the value of the products themselves. While "attractive design," "clear expression," and "quick information retrieval" are certainly important in various content creation, we believe that addressing the risks inherent in communication is also a crucial element. Risks hidden in content include: - 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. Therefore, we offer a range 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, creating, and developing content, and subsequent verification.
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