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  • IEC 62304

    Understanding the IEC 62304 Standard in QMS Context

    eLeaP Editorial Team

    July 26, 2025

    7 min read

    Understanding the IEC 62304 Standard in QMS Context

    The IEC 62304 standard serves as an international framework developed by the International Electrotechnical Commission, defining software lifecycle processes for medical device software. This comprehensive standard ensures the development and maintenance of medical software through rigorous, repeatable, and risk-driven processes that prioritize patient safety above all other considerations. The IEC 62304 standard applies to all […]

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