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    Software in a Medical Device

    Software embedded in or required to operate a hardware medical device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Software in a Medical Device (SiMD) refers to software that is embedded within, or required for, the operation of a hardware medical device - such as firmware controlling an infusion pump or imaging system.

    What this means in practice

    Unlike SaMD, SiMD is regulated as part of the parent device. It is still subject to IEC 62304, cybersecurity requirements, and design controls.

    Cross-references

    Governed by

    Regulations or standards this term must comply with.

    Often confused with

    Distinct concept frequently mistaken for this one.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2IMDRF·1
    1. 1
      FDA Software Functions
      Verified
      FDAfda.gov
    2. 2
      FDA - AI/ML-Enabled Medical Devices
      Verified
      FDAfda.gov
    3. 3
      IMDRF - Software as a Medical Device
      Verified
      IMDRFimdrf.org

    Inline markers like [1] jump to the matching reference above.