DeviceVigilance: 자동화 eMDR 파이프라인, 미국 FDA 21 CFR 803 전자 보고 및 유럽 MDR 시판 후 감시

DeviceVigilance Fleet Telemetry Architecture

Fleet-Wide Sensor Telemetry and Anomaly Detection Core

Central System: Device Surveillance Engine - Fleet Health Analytics Core

Clinical IoMT Nodes

• Telemetry Anomaly Detector
• Field Incident Harvester
• Firmware Drift Monitor
• Regulatory Alert Emitter
• Hospital IT Feed

Architectural Layers & Regulatory Standards

• Hardware Health Telemetry Ingestion (IEEE 11073-10471 Health Device Specialization / MQTT over mTLS): Ingesting internal temperature, motor currents, battery impedance, and calibration offsets.
• Statistical Anomaly & Drift Engine (Isolation Forests / Mahalanobis Distance Health Index): Principal component analysis and isolation forests detecting multi-parametric device degradation.
• Regulatory Reporting Dispatch (FDA 21 CFR 803 Electronic MedWatch / EUDAMED Integration): Automated triage and compilation of MDR / MIR report drafts when safety thresholds are crossed.
• Clinical Engineering Maintenance Link (HL7 FHIR Device / REST Webhooks for Hospital CMMS): Automated dispatch of preventative service tickets directly into hospital CMMS systems.

Key Metrics: 100k+ (Monitored Medical Fleet Scale) | 14 Days (Advance Hardware Failure Warning) | 99.8% (Anomaly Detection Accuracy) | ISO 13485 (Quality Management Conformance)