Software Lifecycle

Cybersecurity10

• Code Signing
• Common Vulnerability Scoring System(CVSS)
• Common Weakness Enumeration(CWE)
• IEC 81001-5-1
• Over-the-Air Updates(OTA)
• Secure Boot
• Secure Software Development Framework(SSDF)
• Software Bill of Materials(SBOM)
• Software Safety Case
• Supply-chain Levels for Software Artifacts(SLSA)

Clinical & Trials1

• Electronic Data Capture(EDC)

Standards2

• IEC 62304
• IEC 82304-1

Software & AI31

• 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)

Market Segments3

• AI Imaging Software
• Digital Therapeutic(DTx)
• Digital Therapeutics(DTx)

Other ecosystems