AgenticSaMD: 확정적 안전 가드레일, 제약된 임상 추론 엔진 및 Class C 고위험 의료 소프트웨어

AgenticSaMD는 자율 에이전트 기반 의료기기 소프트웨어(SaMD)를 위한 엔지니어링 아키텍처와 규제 보호책을 수립하여 다중 에이전트 임상 추론, 우수 머신러닝 관행(GMLP) 및 FDA 및 EU MDR 규정 하의 결정론적 임상 안전 인터록을 결합합니다.

AgenticSaMD Multi-Agent Orchestration & Clinical Guardrail Architecture

Clinical reasoning supervisor, deterministic safety interlock, and automated EHR decision loop

Central System: Clinical Agent Supervisor - GMLP Safety Interlock Core

Clinical IoMT Nodes

  • Diagnostic Reasoning Agent
  • Contraindication Validator
  • Clinical Guideline Arbiter
  • Human-in-the-Loop Gate
  • Audit Trail Notarizer

Architectural Layers & Regulatory Standards

  • Multi-Agent Clinical Reasoning Plane (CoT Agentic Swarms / Specialized Diagnostic Sub-Agents): Distributing clinical analysis across specialized sub-agents: radiology, pathology, pharmacology, and patient history.
  • Deterministic Clinical Guardrails (Rule-Based Deterministic Safety Interlocks): Vetoing agent recommendations that violate established clinical dosage, contraindication, or allergy boundaries.
  • Physician-in-the-Loop Attestation (Clinician Attestation & Structured Override UI): Requiring board-certified physician sign-off before committing high-stakes diagnostic or therapeutic recommendations.
  • Continuous Real-World Vigilance (Automated Drift Telemetry & Adverse Event Tracing): Monitoring agent diagnostic concordance and logging reasoning steps for post-market surveillance.

Key Metrics: Class C (IEC 62304 Safety Tier) | 100% (Deterministic Guardrail Veto) | < 450 ms (Multi-Agent Consensus Time) | Zero Hallucination (Clinical Grounding Margin)

자율 에이전틱 소프트웨어 의료기기, 다중 에이전트 임상의사결정 지원 및 FDA GMLP 가드레일

Authoritative technical engineering reference for autonomous agentic software as a medical device, multi-agent clinical decision support & fda gmlp guardrails 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