SaMDOps: 医疗软件持续 MLOps、IEC 62304 自动化 CI/CD 与模型漂移遥测

SaMDOps 打造专为严密监管医疗器械软件定制的自动化 MLOps 与 DevSecOps 持续集成与发布管道，自动化执行 IEC 62304 软件生命周期核验、在线模型性能概念漂移 (Model Drift) 预警及 FDA 获批医疗 AI 的上市后电子化警戒监护 (PMS)。

SaMDOps Automated CI/CD & Clinical Vigilance Architecture

Automated regression testing, model drift detector, and electronic PMS compliance pipeline

Central System: SaMDOps Pipeline Controller - IEC 62304 CI/CD Engine

Clinical IoMT Nodes

  • Automated Unit Verifier
  • Model Drift Monitor
  • Traceability Linker
  • De-Identification Sanitizer
  • PMS Report Generator

Architectural Layers & Regulatory Standards

  • Regulated CI/CD Pipeline Plane (GitLab CI / GitHub Actions with GxP Compliance): Enforcing mandatory automated code testing, static analysis, and cryptographic build provenance.
  • Medical Machine Learning Operations (MLflow / Kubeflow with Dataset Versioning (DVC)): Tracking exact dataset hashes, model hyperparameters, and validation ROC curves for every build.
  • Continuous Model Drift Detection (Real-Time Population Stability Index (PSI) Telemetry): Alerting clinical teams when changes in hospital populations degrade model diagnostic accuracy.
  • Electronic Post-Market Surveillance (Automated PSUR / CER Evidence Compilation): Generating annual Periodic Safety Update Reports (PSUR) required by European Notified Bodies.

Key Metrics: 100% MC/DC (Code Coverage Verification) | Automated (Audit Trail Generation) | < 10 min (Regulatory Build Compilation) | 21 CFR Part 11 (Electronic Signature Ready)

持续SaMD MLOps、自动化IEC 62304回归CI/CD、模型漂移遥测与上市后监测（PMS）

深入剖析 FDA 510(k)/PMA 申报、EU MDR、IEC 62304 C级软件生命周期及 IoMT 零信任互操作架构中的Continuous SaMD MLOps, Automated IEC 62304 Regression CI/CD, Model Drift Telemetry & Post-Market Surveillance (PMS)关键工程实践。

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications