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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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