SaMDOps: 지속적 의료 MLOps, IEC 62304 규격 CI/CD 및 모델 드리프트 원격 측정

SaMDOps는 규제 대상 의료 소프트웨어를 위해 특별히 구축된 자동화된 MLOps 및 DevSecOps 파이프라인을 제공하여 지속적인 IEC 62304 검증, 자동 모델 드리프트 모니터링 및 FDA 승인 임상 AI를 위한 시판 후 조사(PMS)를 수행합니다.

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)

지속적 SaMD MLOps, 자동화 IEC 62304 회귀 CI/CD, 모델드리프트 텔레메트리 및 시판후조사(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