SaMDOps: MLOps Médical Continu, CI/CD CEI 62304 et Télémétrie de Dérive

SaMDOps fournit des pipelines MLOps et DevSecOps automatisés conçus pour les logiciels médicaux réglementés, exécutant la vérification continue IEC 62304, la détection de dérive des modèles et la surveillance après commercialisation (PMS) pour l'IA clinique validée par la FDA.

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)

MLOps continu pour SaMD, CI/CD de régression IEC 62304 automatisé, télémétrie de dérive de modèle et surveillance post-commercialisation (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

Automated IEC 62304 CI/CD — Core clinical engineering and protocols for Automated IEC 62304 CI/CD.
Clinical Model Drift Monitoring — Core clinical engineering and protocols for Clinical Model Drift Monitoring.
Automated PSUR Compilation — Core clinical engineering and protocols for Automated PSUR Compilation.

Technical Articles

Related Cluster Architecture Specifications

HealthVigilance — Zero-Trust IoMT Architecture, SaMD Risk Engineering & Autonomous Clinical Post-Market Vigilance
AgenticSaMD — Autonomous Agentic Software as a Medical Device, Multi-Agent Clinical Decision Support & FDA GMLP Guardrails
AITelemonitoring — Autonomous AI Telemonitoring, Virtual Nursing Assistants & Predictive Clinical Deterioration Scoring
BCI2IoMT — Brain-Computer Interface IoMT Gateways, Neural Decoding & Electrophysiological Streaming