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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.
37 terms
Cybersecurity6
Standards2
Software & AI26
- Adversarial Robustness
- AI/ML-Enabled Medical Device
- Algorithmic Bias and Fairness
- Clinical Decision Support(CDS)
- Data Governance (AI/ML)
- 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
- 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)