--- title: "Software Lifecycle - MedTech Ecosystems" description: "How software-as-a-medical-device and embedded device software get designed, verified, validated, and maintained - IEC 62304, IEC 82304, usability standards,…" lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About [All ecosystems](/ecosystems) Ecosystem # Software Lifecycle How software-as-a-medical-device and embedded device software get designed, verified, validated, and maintained - IEC 62304, IEC 82304, usability standards, and the IMDRF SaMD risk framework. 47 terms ## Cybersecurity10 - [Code Signing ](/terms/code-signing) - [Common Vulnerability Scoring System(CVSS) ](/terms/cvss) - [Common Weakness Enumeration(CWE) ](/terms/cwe) - [IEC 81001-5-1 ](/terms/iec-81001-5-1) - [Over-the-Air Updates(OTA) ](/terms/ota-updates) - [Secure Boot ](/terms/secure-boot) - [Secure Software Development Framework(SSDF) ](/terms/ssdf) - [Software Bill of Materials(SBOM) ](/terms/sbom) - [Software Safety Case ](/terms/software-safety-case) - [Supply-chain Levels for Software Artifacts(SLSA) ](/terms/slsa) ## Clinical & Trials1 - [Electronic Data Capture(EDC) ](/terms/edc) ## Standards2 - [IEC 62304 ](/terms/iec-62304) - [IEC 82304-1 ](/terms/iec-82304-1) ## Software & AI31 - [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) ## Market Segments3 - [AI Imaging Software ](/terms/ai-imaging) - [Digital Therapeutic(DTx) ](/terms/samd-dtx) - [Digital Therapeutics(DTx) ](/terms/digital-therapeutics) ### Other ecosystems [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)[Startup Lifecycle](/ecosystems/startup-lifecycle)[Strategic Landscape](/ecosystems/strategic-landscape)[Manufacturing & Supply](/ecosystems/manufacturing-supply) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)