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    Software & AISoftware Lifecycle

    Software Maintenance Plan

    IEC 62304 §6 documented plan for handling problem reports, changes, and releases over the software lifecycle.

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

    Definition

    The Software Maintenance Plan covers problem and modification analysis, modification implementation, system release, and migration/retirement. It bridges the gap between design controls and post-market software changes.

    What this means in practice

    A robust maintenance plan is what makes Letter-to-File decisions defensible and prevents post-market changes from becoming new submissions.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    IEC·1FDA·1IMDRF·1
    1. 1
      IEC 62304
      Verified
      IECwebstore.iec.ch
    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.