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    AAMI TIR45

    AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    Definition

    AAMI TIR45 is a Technical Information Report providing guidance on the use of Agile software development practices (Scrum, Kanban, XP) in the development of medical device software within the framework of IEC 62304. It addresses how Agile incremental and iterative development can be reconciled with the structured documentation, planning, and verification requirements of IEC 62304, ISO 13485, and FDA's software design controls. Topics include backlog management as a planning artifact, definition of done as a verification gate, continuous integration with regulated builds, and how to align sprint cadence with documentation milestones.
    What the regulation says
    AAMI TIR45 is FDA-recognized in the Recognized Consensus Standards database. IEC 62304 §5 expects a documented software development lifecycle; TIR45 is the standard reference for documenting an Agile lifecycle under that requirement.

    What this means in practice

    Almost every medical device software organization today uses Agile in some form, but few originally documented their Agile-to-IEC 62304 mapping rigorously. TIR45 provides the bridge regulators and notified bodies expect to see. It is referenced in FDA's General Principles of Software Validation guidance and recognized as a consensus standard. Organizations adopting TIR45 typically tailor it to map their specific Agile ceremonies and artifacts to the IEC 62304 process outputs.
    Common pitfalls
    • •Adopting Agile without documenting the mapping to IEC 62304 process outputs, the standard requires evidence, not framework choice.
    • •Treating the backlog as the only planning artifact, IEC 62304 still expects a software development plan that backlog items refine.
    • •Skipping the 'definition of done' rigor, without verification evidence per increment, regression and integration testing burdens shift to release time.

    Primary references

    3 sources
    Link health: 1 verified 2 bot-blocked· last checked 2026-06-20
    FDA·2AAMI·1
    1. 1
      AAMI TIR45 (recognized standards database)
      Verified
      FDAaccessdata.fda.gov
    2. 2
      AAMI TIR45
      Bot-blocked
      AAMIarray.aami.org
    3. 3
      FDA - AI/ML-Enabled Medical Devices
      Bot-blocked
      FDAfda.gov

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