--- title: "TIR45, AAMI TIR45 | MedTech Terms" description: "AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/aami-tir45#term", "name": "AAMI TIR45", "alternateName": [ "TIR45", "AAMI TIR45:2012/(R)2018", "Guidance on the use of AGILE practices in the development of medical device software" ], "description": "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. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. AAMI TIR45 [All terms](/terms) Software & AI [Software Lifecycle](/ecosystems/software-lifecycle)TIR45 # 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 Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition [AAMI](/terms/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](/terms/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](/terms/iso-13485), and FDA's software [design controls](/terms/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](/terms/aami) TIR45 is FDA-recognized in the Recognized Consensus Standards database. [IEC 62304](/terms/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](/terms/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. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd)[ Software & AI Software Safety Classification IEC 62304 classes A, B, C reflecting potential harm from software failure. ](/terms/software-safety-class)[ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls)[ Standards IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304) ### More in Software & AI · Same category [ Software & AI Adversarial Robustness Resilience of an ML model to inputs deliberately crafted to cause misclassification. ](/terms/adversarial-robustness)[ Software & AI AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. ](/terms/ai-ml-device)[ Software & AI Algorithm Change Protocol(ACP) The detailed procedural section of a PCCP that specifies how planned modifications to an AI/ML model will be developed, validated, and implemented. ](/terms/algorithm-change-protocol)[ Software & AI Algorithmic Bias and Fairness Systematic differences in model performance across demographic or clinical subgroups. ](/terms/ai-bias-fairness) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Software Lifecycle](/ecosystems/software-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 AAMI· 1 1. [1 AAMI TIR45 (recognized standards database) Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) 2. [2 AAMI TIR45 Verified AAMI · array.aami.org ](https://array.aami.org/doi/book/10.2345/9781570204562) 3. [3 FDA - AI/ML-Enabled Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Software & AI Acronym TIR45 Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=aami-tir45) Learn in 60 seconds Card Lesson Quiz AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle. - · 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. Remember this Watch out: Adopting Agile without documenting the mapping to IEC 62304 process outputs, the standard requires evidence, not framework choice. Related terms - [IEC 62304 ](/terms/iec-62304) - [IEC 81001-5-1 ](/terms/iec-81001-5-1) - [Software Safety Classification ](/terms/software-safety-class) - [Verification & Validation(V&V) ](/terms/verification-validation) - [Design Controls ](/terms/design-controls) - [Software as a Medical Device(SaMD) ](/terms/samd) You may also need Auto-suggested from Software & AI and shared keywords. - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [AAMI SW96 ](/terms/aami-sw96) - [AAMI TIR57 ](/terms/aami-tir57) - [Secure Product Development Framework(SPDF) ](/terms/spdf) - [Threat Modeling ](/terms/threat-modeling) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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