AAMI TIR45
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.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.- •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.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsSoftware intended for medical purposes that performs without being part of a hardware device.
IEC 62304 classes A, B, C reflecting potential harm from software failure.
Structured process governing the design of medical devices.
Lifecycle requirements for medical device software.
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Medical device that uses artificial intelligence or machine learning to perform its intended use.
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Primary references
3 sources- 1
AAMI TIR45 (recognized standards database)VerifiedFDAaccessdata.fda.gov
- 2
AAMI TIR45VerifiedAAMIarray.aami.org
- 3
FDA - AI/ML-Enabled Medical DevicesVerifiedFDAfda.gov
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