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    Software & AISoftware LifecycleTIR45

    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 TIR45:2023 provides recommendations for using Agile practices in medical device software development alongside applicable standards and FDA guidance. FDA recognizes the complete 2023 report as recognition 13-143, entered May 26, 2025. Declarations to the superseded 2012 edition remain accepted until July 2, 2028. It does not replace IEC 62304 or the manufacturer’s required lifecycle evidence. Do not claim that FDA’s 2002 General Principles of Software Validation guidance references a report first published in 2012.

    What this means in practice

    AAMI TIR45:2023 provides recommendations for using Agile practices in medical device software development alongside applicable standards and FDA guidance. FDA recognizes the complete 2023 report as recognition 13-143, entered May 26, 2025. Declarations to the superseded 2012 edition remain accepted until July 2, 2028. It does not replace IEC 62304 or the manufacturer’s required lifecycle evidence. Do not claim that FDA’s 2002 General Principles of Software Validation guidance references a report first published in 2012.

    Examples

    • Hypothetical: a team documents how its Agile review records meet applicable design-review and lifecycle requirements rather than assuming a sprint review automatically satisfies them.
    • Illustrative: A startup building a diagnostic imaging AI algorithm implemented TIR45 guidance to align their continuous integration practices with the regulated build and configuration management needs of medical device software.
    • Illustrative: During an audit, a notified body reviewed a medical device manufacturer's process, observing how their 'Definition of Done' for user stories was mapped directly to the verification activities required by IEC 62304, as suggested by TIR45.
    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.

    Frequently asked questions

    No, TIR45 does not replace IEC 62304, it provides guidance on how to satisfy IEC 62304's structured lifecycle, documentation, and verification requirements while using Agile practices such as Scrum, Kanban, or Extreme Programming. IEC 62304 remains the normative standard defining what the software development lifecycle must accomplish, and TIR45 is the recognized bridge showing how Agile ceremonies and artifacts can map onto those requirements.

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    Sources

    4 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Official-source claim check:

    AAMI TIR45:2023 provides Agile-development recommendations and is FDA-recognized in full as 13-143; recognition of the 2012 edition transitions through July 2, 2028.

    Partial review: verified corrections are applied, but this is not a full accuracy certification. The last full review date is unchanged.

    Remaining verification limits
    • Original merged record reviewed in full. Illustrative examples are hypothetical, not verified case histories. Evidence supports the specific propositions below, not an assertion that every linked page verifies all merged content.
    • Full paid AAMI report not available in this review. Detailed claims about backlog artifacts, definition of done, sprint gates, and section mappings remain partial, supported only at general scope level by publisher abstract.
    Tier 2Regulator guidance and consensus· 4
    Link health: 2 verified 2 unchecked· last checked 2026-06-20
    FDA·3AAMI·1
    1. 1
      AAMI TIR45 (recognized standards database)
      Tier 2 Verified
      FDAaccessdata.fda.gov
    2. 2
      AAMI TIR45
      Tier 2 Unchecked
      AAMIarray.aami.org
    3. 3
      FDA - AI/ML-Enabled Medical Devices
      Tier 2 Verified
      FDAfda.gov
    4. 4
      FDA recognition 13-143
      Tier 2 Unchecked
      FDAaccessdata.fda.gov

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