AgenticSaMD: Guardrails Determinísticos, Raciocínio Agêntico Delimitado e Software Médico Classe C

O AgenticSaMD estabelece arquiteturas de engenharia e salvaguardas regulatórias para Software como Dispositivo Médico (SaMD) baseado em agentes autônomos, combinando raciocínio clínico multiagente, Boas Práticas de Machine Learning (GMLP) e travas determinísticas de segurança clínica sob os marcos da FDA e EU MDR.

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)

Software Agêntico Autônomo como Dispositivo Médico, Suporte à Decisão Clínica Multi-Agente e Barreiras de Proteção GMLP da FDA

Referência técnica de engenharia autoritativa para autonomous agentic software as a medical device, multi-agent clinical decision support & fda gmlp guardrails em submissões FDA 510(k)/PMA, EU MDR, ciclo de vida IEC 62304 Classe C, ISO 13485 e interoperabilidade IoMT com segurança zero-trust.

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications