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

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.

Why it matters

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 Declarations to the superseded 2012 edition remain accepted until July 2, 2028.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.

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.

Sources

AAMI TIR45 (recognized standards database) · FDA
AAMI TIR45 · AAMI
FDA - AI/ML-Enabled Medical Devices · FDA
FDA recognition 13-143 · FDA

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