--- title: "Software & AI Terms - MedTech Terms" description: "SaMD, SiMD, AI/ML models, and software lifecycle terminology. 31 vendor-neutral definitions with primary-source citations." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTermSet", "@id": "https://medtechterms.com/categories/software-and-ai#set", "name": "Software & AI - MedTech Terms", "description": "SaMD, SiMD, AI/ML models, and software lifecycle terminology.", "url": "https://medtechterms.com/categories/software-and-ai", "hasDefinedTerm": [ { "@type": "DefinedTerm", "name": "AAMI TIR45", "alternateName": "TIR45", "url": "https://medtechterms.com/terms/aami-tir45", "termCode": "aami-tir45" }, { "@type": "DefinedTerm", "name": "Adversarial Robustness", "url": "https://medtechterms.com/terms/adversarial-robustness", "termCode": "adversarial-robustness" }, { "@type": "DefinedTerm", "name": "AI/ML-Enabled Medical Device", "url": "https://medtechterms.com/terms/ai-ml-device", 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"DefinedTerm", "name": "Explainability and Interpretability", "url": "https://medtechterms.com/terms/explainability", "termCode": "explainability" }, { "@type": "DefinedTerm", "name": "Federated Learning", "url": "https://medtechterms.com/terms/federated-learning", "termCode": "federated-learning" }, { "@type": "DefinedTerm", "name": "Foundation Model (Healthcare)", "url": "https://medtechterms.com/terms/foundation-model-health", "termCode": "foundation-model-health" }, { "@type": "DefinedTerm", "name": "Generative AI in Medical Devices", "url": "https://medtechterms.com/terms/generative-ai-devices", "termCode": "generative-ai-devices" }, { "@type": "DefinedTerm", "name": "Good Machine Learning Practice", "alternateName": "GMLP", "url": "https://medtechterms.com/terms/good-machine-learning-practice", "termCode": "good-machine-learning-practice" }, { "@type": "DefinedTerm", "name": "Interoperability", "url": "https://medtechterms.com/terms/interoperability", "termCode": "interoperability" }, { "@type": "DefinedTerm", "name": "Locked vs. Adaptive Algorithm", "url": "https://medtechterms.com/terms/locked-vs-adaptive", "termCode": "locked-vs-adaptive" }, { "@type": "DefinedTerm", "name": "Medical Device Data System", "alternateName": "MDDS", "url": "https://medtechterms.com/terms/mdds", "termCode": "mdds" }, { "@type": "DefinedTerm", "name": "MLOps for Medical Devices", "alternateName": "MLOps", "url": "https://medtechterms.com/terms/mlops-medical-device", "termCode": "mlops-medical-device" }, { "@type": "DefinedTerm", "name": "Model Card", "url": "https://medtechterms.com/terms/model-card", "termCode": "model-card" }, { "@type": "DefinedTerm", "name": "Model Drift Monitoring", "url": "https://medtechterms.com/terms/drift-monitoring", "termCode": "drift-monitoring" }, { "@type": "DefinedTerm", "name": "ONC HTI-1 / HTI-2", "url": "https://medtechterms.com/terms/onc-hti", "termCode": "onc-hti" }, { "@type": "DefinedTerm", "name": "Predetermined Change 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Unknown Provenance", "alternateName": "SOUP", "url": "https://medtechterms.com/terms/soup", "termCode": "soup" }, { "@type": "DefinedTerm", "name": "Software Safety Classification", "url": "https://medtechterms.com/terms/software-safety-class", "termCode": "software-safety-class" }, { "@type": "DefinedTerm", "name": "Synthetic Data", "url": "https://medtechterms.com/terms/synthetic-data", "termCode": "synthetic-data" }, { "@type": "DefinedTerm", "name": "Total Product Lifecycle", "alternateName": "TPLC", "url": "https://medtechterms.com/terms/tplc", "termCode": "tplc" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Categories", "item": "https://medtechterms.com/categories" }, { "@type": "ListItem", "position": 3, "name": "Software & AI", "item": "https://medtechterms.com/categories/software-and-ai" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All categories](/categories)Category # Software & AI SaMD, SiMD, AI/ML models, and software lifecycle terminology. 31 terms [Filter in glossary](/terms?cat=Software%20%26%20AI) ## Popular software & ai terms [ AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. ](/terms/ai-ml-device)[ EU AI Act EU regulation establishing risk-based requirements for AI systems, including most medical AI. ](/terms/eu-ai-act)[ Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. ](/terms/ai-ml-pccp)[ Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd) ## All Software & AI terms - [AAMI TIR45(TIR45) ](/terms/aami-tir45) - [Adversarial Robustness ](/terms/adversarial-robustness) - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Algorithmic Bias and Fairness ](/terms/ai-bias-fairness) - [Clinical Decision Support(CDS) ](/terms/cds) - [Data Governance (AI/ML) ](/terms/data-governance) - [Datasheets for Datasets ](/terms/datasheets-for-datasets) - [EU AI Act ](/terms/eu-ai-act) - [Explainability and Interpretability ](/terms/explainability) - [Federated Learning ](/terms/federated-learning) - [Foundation Model (Healthcare) ](/terms/foundation-model-health) - [Generative AI in Medical Devices ](/terms/generative-ai-devices) - [Good Machine Learning Practice(GMLP) ](/terms/good-machine-learning-practice) - [Interoperability ](/terms/interoperability) - [Locked vs. Adaptive Algorithm ](/terms/locked-vs-adaptive) - [Medical Device Data System(MDDS) ](/terms/mdds) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Model Card ](/terms/model-card) - [Model Drift Monitoring ](/terms/drift-monitoring) - [ONC HTI-1 / HTI-2 ](/terms/onc-hti) - [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) - [Predetermined Maintenance vs PCCP ](/terms/predetermined-maintenance) - [Secure-by-Design (Devices) ](/terms/secure-by-design) - [Software as a Medical Device(SaMD) ](/terms/samd) - [Software in a Medical Device(SiMD) ](/terms/simd) - [Software Maintenance Plan ](/terms/software-maintenance-plan) - [Software of Unknown Provenance(SOUP) ](/terms/soup) - [Software Safety Classification ](/terms/software-safety-class) - [Synthetic Data ](/terms/synthetic-data) - [Total Product Lifecycle(TPLC) ](/terms/tplc) ## Explore related categories [Regulatory](/categories/regulatory)[Quality & Risk](/categories/quality-and-risk)[Cybersecurity](/categories/cybersecurity)[Clinical & Trials](/categories/clinical-and-trials)[Standards](/categories/standards)[Manufacturing](/categories/manufacturing)[Post-Market](/categories/post-market)[Investment & Finance](/categories/investment-and-finance)[Market Segments](/categories/market-segments)[Reimbursement](/categories/reimbursement)[Commercialization](/categories/commercialization)[Industry Bodies](/categories/industry-bodies) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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