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Software User Interface Requirements for Medical Devices

    https://www.mddionline.com/news/software-user-interface-requirements-medical-devices
    FDA defines validation in the General Principles of Software Validation (2002) as “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular …

European Language Translation Requirements for Medical …

    https://medenvoyglobal.com/european-language-translation-requirements-for-medical-device-labeling-ifus-and-software/
    Shown below are the medical device language requirements for devices sold in European countries. This includes all EU and EEA countries plus a few others. This …

EU MDR – Language requirements - omcmedical.com

    https://omcmedical.com/eu-mdr-language-requirements/
    In general terms the most commonly required information is the product information – Labelling, packaging and Information for use (IFU) in some cases User …

IEC 62304 compliance - What are the …

    https://www.tuleap.org/software-quality/iec62304-requirements-medical-device-software-standard
    a software embedded in medical devices, a computer software, a smartphone application (such as HealthMap, mobile health applications). NOTE For PC and …



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