SaMDOps: Непрерывный медицинский MLOps, CI/CD по IEC 62304 и телеметрия дрейфа

SaMDOps предоставляет автоматизированные конвейеры MLOps и DevSecOps для медицинского ПО, выполняя верификацию по IEC 62304, мониторинг дрейфа моделей и постмаркетинговый надзор (PMS) для сертифицированного FDA клинического ИИ.

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)

Непрерывный MLOps для SaMD, автоматизированный регрессионный CI/CD по IEC 62304, телеметрия дрейфа модели и постмаркетинговый надзор (PMS)

Authoritative technical engineering reference for continuous samd mlops, automated iec 62304 regression ci/cd, model drift telemetry & post-market surveillance (pms) in FDA Premarket submissions, EU MDR, IEC 62304 Class C software lifecycle, ISO 13485 quality systems, and IoMT zero-trust interoperability.

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications