What AI/ML Model Lifecycle Management in Healthcare (2026) requires
Total Product Lifecycle (TPLC) management for AI/ML-based Medical Devices, incorporating Good Machine Learning Practice (GMLP). It covers requirements for continuous post-market surveillance, algorithmic bias monitoring, and strict change control protocols for adaptive learning algorithms in clinical environments.
Pillar: Medical & Healthcare · Authority: IMDRF & FDA (Digital Health Center of Excellence) · Version: 1.0.0 · Last updated:
Primary source: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
SHA-256 integrity: 5a9ca46d4fa595b33eeb41e8cb31680038e02e461f111e6cc8c2da75e027b8ac
Primary Citations — 2 traced to source
- FDA Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
- IMDRF Machine Learning-enabled Medical Devices: Key Terms and Concepts
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- Discovery (free): /api/v1/nodes/health-ai-lifecycle-management-2026.json — 6-field metadata
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- Canonical URL: https://bidda.com/intelligence/health-ai-lifecycle-management-2026
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