AI / ML in Devices

Cybersecurity5

• LINDDUN
• MITRE ATT&CK(ATT&CK)
• STRIDE Threat Model(STRIDE)
• Threat Modeling
• Zero Trust Architecture(ZTA)

Standards1

• ISO/IEC 23894

Software & AI20

• Adversarial Robustness
• AI/ML-Enabled Medical Device
• Algorithm Change Protocol(ACP)
• Algorithmic Bias and Fairness
• 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)
• Locked vs. Adaptive Algorithm
• MLOps for Medical Devices(MLOps)
• Model Card
• Model Drift Monitoring
• ONC HTI-1 / HTI-2
• Predetermined Change Control Plan(PCCP)
• Predetermined Maintenance vs PCCP
• Synthetic Data

Market Segments1

• AI Imaging Software

Reimbursement1

• Budget Impact Model(BIM)

Commercialization1

• Razor / Razor-Blade Model

Other ecosystems