SaMDOps: MLOps Médico Continuo, CI/CD IEC 62304 y Telemetría de Deriva

SaMDOps suministra canalizaciones de MLOps y DevSecOps diseñadas para software médico regulado, con verificación continua de IEC 62304, monitorización de deriva de modelos (drift) y vigilancia post-comercialización (PMS) para IA clínica aprobada por 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 Continuo para SaMD, CI/CD de Regresión IEC 62304 Automatizado, Telemetría de Desviación de Modelo y Vigilancia Postcomercialización (PMS)

Referencia técnica de ingeniería autorizada para continuous samd mlops, automated iec 62304 regression ci/cd, model drift telemetry & post-market surveillance (pms) en regulaciones FDA 510(k), EU MDR, ciclo de vida IEC 62304 Clase C e interoperabilidad IoMT.

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