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Software as a Medical Device (SaMD) | FDA

    https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
    The term Software as a Medical DeviceExternal Link Disclaimer is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." Use of Software as a Medical … See more

Global Approach to Software as a Medical Device | FDA

    https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device
    The IMDRF Quality Management System for Software as a Medical Device (SaMD) framework helps manufacturers and international regulators attain a common …

IEC 62304 - Wikipedia

    https://en.wikipedia.org/wiki/IEC_62304

    ISO - IEC 62304:2006 - Medical device software — …

      https://www.iso.org/standard/38421.html
      Medical device software — Software life cycle processes. This standard was last reviewed and confirmed in 2021. Therefore this version remains current. Defines the life cycle …



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