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Software & AI
SaMD, SiMD, AI/ML models, and software lifecycle terminology.
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Popular software & ai terms
AI/ML-Enabled Medical Device
Medical device that uses artificial intelligence or machine learning to perform its intended use.
EU AI Act
EU regulation establishing risk-based requirements for AI systems, including most medical AI.
Predetermined Change Control Plan(PCCP)
FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.
Software as a Medical Device(SaMD)
Software intended for medical purposes that performs without being part of a hardware device.
All Software & AI terms
- AAMI TIR45(TIR45)
- Adversarial Robustness
- AI/ML-Enabled Medical Device
- Algorithm Change Protocol(ACP)
- Algorithmic Bias and Fairness
- Clinical Decision Support(CDS)
- Data Governance (AI/ML)
- Datasheets for Datasets
- EU AI Act
- Explainability and Interpretability
- Federated Learning
- Foundation Model (Healthcare)
- Generative AI in Medical Devices
- Good Machine Learning Practice(GMLP)
- Interoperability
- Locked vs. Adaptive Algorithm
- Medical Device Data System(MDDS)
- MLOps for Medical Devices(MLOps)
- Model Card
- Model Drift Monitoring
- ONC HTI-1 / HTI-2
- Predetermined Change Control Plan(PCCP)
- Predetermined Maintenance vs PCCP
- Secure-by-Design (Devices)
- Software as a Medical Device(SaMD)
- Software in a Medical Device(SiMD)
- Software Maintenance Plan
- Software of Unknown Provenance(SOUP)
- Software Safety Classification
- Synthetic Data
- Total Product Lifecycle(TPLC)