--- title: "SaMD, Software as a Medical Device | MedTech Terms" description: "Software intended for medical purposes that performs without being part of a hardware device. 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Software as a Medical Device [All terms](/terms) Software & AI [Software Lifecycle](/ecosystems/software-lifecycle)SaMD /sam-dee/ # Software as a Medical Device Software intended for medical purposes that performs without being part of a hardware device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Per [IMDRF](/terms/imdrf), Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. ## What this means in practice SaMD spans diagnostic apps, AI triage tools, and [clinical decision support](/terms/cds) systems. [IMDRF](/terms/imdrf) risk categorization (I to IV) considers the state of the healthcare situation (non-serious, serious, critical) and the significance of the information the SaMD provides (inform, drive, treat or diagnose). Regulators worldwide, including FDA, MHRA, and Health Canada, align to the IMDRF framework. ## Examples - A mobile app that analyzes retinal images to screen for diabetic retinopathy without connecting to hardware. - A cloud service that triages CT scans and flags suspected large-vessel occlusion strokes for radiologist review. - AI software that estimates ejection fraction from standard echocardiograms. ## Use cases 1 scenario 1 ### Mobile app analyzing skin lesions for melanoma risk Founder / RA The app meets the FDA SaMD definition. The team applies [IMDRF](/terms/imdrf) risk categorization, follows [IEC 62304](/terms/iec-62304) for software lifecycle, and uses [GMLP](/terms/good-machine-learning-practice) principles for the underlying model. They submit a 510(k) with a cleared dermatology AI as predicate. Outcome The product launches as a regulated Class II SaMD with a clear update pathway via a [Predetermined Change Control Plan](/terms/ai-ml-pccp). Common pitfalls - • Confusing SaMD with SiMD. If the software is embedded in or required to operate a hardware device, it is SiMD and regulated with the parent device. - • Assuming a wellness app is out of scope. Once the intended use includes diagnosis, treatment, cure, mitigation, or prevention, the software is likely SaMD. - • Skipping IEC 62304 lifecycle documentation because the product feels like a normal SaaS release cycle. - • Treating model updates as bug fixes. Retrained AI models often require a Predetermined Change Control Plan or a new submission. ## Frequently asked questions What is the difference between SaMD and SiMD? SaMD (Software as a Medical Device) performs a medical purpose without being part of a hardware device. [SiMD](/terms/simd) (Software in a Medical Device) is embedded in or required to operate a hardware device, such as pump firmware or imaging system control software. Is every mobile health app a SaMD? What standards apply to SaMD? How does FDA regulate AI-based SaMD? ## Cross-references ### Governed by Regulations or standards this term must comply with. - [ IEC 62304 ](/terms/iec-62304) ### Often confused with Distinct concept frequently mistaken for this one. - [ Software in a Medical Device(SiMD) SaMD is standalone software; SiMD is software inside a device. ](/terms/simd) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. ](/terms/ai-ml-pccp)[ Software & AI Software in a Medical Device(SiMD) Software embedded in or required to operate a hardware medical device. ](/terms/simd)[ Software & AI Clinical Decision Support(CDS) Software providing healthcare professionals with knowledge and patient-specific information. ](/terms/cds)[ Standards IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304) ### SaMD & AI/ML Devices · From this learning path [ Software & AI Good Machine Learning Practice(GMLP) Guiding principles for the development of AI/ML-enabled medical devices. ](/terms/good-machine-learning-practice?from=samd-and-ai)[ Software & AI Software of Unknown Provenance(SOUP) Software not developed for medical device use, or lacking adequate development records, incorporated into a device. ](/terms/soup?from=samd-and-ai)[ Software & AI Software Safety Classification IEC 62304 classes A, B, C reflecting potential harm from software failure. ](/terms/software-safety-class?from=samd-and-ai)[ Software & AI Interoperability Ability of devices and systems to exchange and use information. ](/terms/interoperability?from=samd-and-ai) ### Software Team Onboarding · From this learning path [ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b?from=software-team-onboarding)[ Cybersecurity Secure Product Development Framework(SPDF) A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle. ](/terms/spdf?from=software-team-onboarding)[ Cybersecurity Software Bill of Materials(SBOM) A machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device. ](/terms/sbom?from=software-team-onboarding)[ Cybersecurity Threat Modeling A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat. ](/terms/threat-modeling?from=software-team-onboarding) ### AI/ML Devices Deep Dive · From this learning path [ Software & AI Foundation Model (Healthcare) Large pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting. Adjacent lesson ](/terms/foundation-model-health?from=ai-ml-devices-deep-dive)[ 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?from=ai-ml-devices-deep-dive)[ Software & AI Explainability and Interpretability Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction. ](/terms/explainability?from=ai-ml-devices-deep-dive)[ Software & AI Generative AI in Medical Devices Devices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow. ](/terms/generative-ai-devices?from=ai-ml-devices-deep-dive) Cited by Where this term appears across MedTech Terms. Learning paths (3) - [SaMD & AI/ML Devices](/paths/samd-and-ai)Lesson 1 of 9 - [Software Team Onboarding](/paths/software-team-onboarding)Lesson 1 of 12 - [AI/ML Devices Deep Dive](/paths/ai-ml-devices-deep-dive)Lesson 9 of 9 Ecosystems (1) - [Software Lifecycle](/ecosystems/software-lifecycle) Comparisons (1) - [SaMD vs SiMD](/compare/samd-vs-simd)vs Software in a Medical Device ## Mentioned in recent activity 2 entries PubMed (2) [Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. ](https://pubmed.ncbi.nlm.nih.gov/42173550/) BMJ health & care informatics · 2026-05-22 [Proceedings from the 2025 Midwest Pediatric Device Consortium showcase featuring software as a medical device. ](https://pubmed.ncbi.nlm.nih.gov/42108451/) BMC proceedings · 2026-05-11 ## Latest in MedTech [View all](/latest?term=samd) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-05-22 [Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. ](https://pubmed.ncbi.nlm.nih.gov/42173550/) BMJ health & care informatics - PubMed 2026-05-11 [Proceedings from the 2025 Midwest Pediatric Device Consortium showcase featuring software as a medical device. ](https://pubmed.ncbi.nlm.nih.gov/42108451/) BMC proceedings ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 IMDRF· 1 FDA· 2 1. [1 IMDRF SaMD Verified IMDRF · imdrf.org ](https://www.imdrf.org/working-groups/software-medical-device-samd) 2. [2 FDA SaMD Resources Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd) 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 SaMD Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=samd) Learn in 60 seconds Card Lesson Quiz Software intended for medical purposes that performs without being part of a hardware device. - · SaMD spans diagnostic apps, AI triage tools, and clinical decision support systems. - · Regulators worldwide, including FDA, MHRA, and Health Canada, align to the IMDRF framework. Remember this Watch out: Confusing SaMD with SiMD. If the software is embedded in or required to operate a hardware device, it is SiMD and regulated with the parent device. Related terms - [Software in a Medical Device(SiMD) ](/terms/simd) - [IEC 62304 ](/terms/iec-62304) - [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) - [Clinical Decision Support(CDS) ](/terms/cds) - [ISO 14971 ](/terms/iso-14971) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) You may also need Auto-suggested from Software & AI and shared keywords. - [Medical Device Data System(MDDS) ](/terms/mdds) - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [Algorithmic Bias and Fairness ](/terms/ai-bias-fairness) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Data Governance (AI/ML) ](/terms/data-governance) - [Federated Learning ](/terms/federated-learning) [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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