Simulate Change
Intelligence Modules
Cybersecurity Lifecycle Manufacturing Intelligence Post-Market Surveillance AI Governance & GMLP Evidence Intelligence
Platform & Engines
Regulatory Digital Twin Decision Simulator Portfolio Command Center 9 Specialized AI Agents
SPECIALIZED INTELLIGENCE NETWORK 9 Domain-Tuned Models Deterministic Grounding Human-in-the-Loop Gate

A network of specialized intelligence, not one generic chatbot.

General-purpose generative language models hallucinate non-existent standards, conflate regulatory jurisdictions, and invent test numbers. Regulated medical engineering demands determinism. PMX OS deploys a federated collective of 9 domain-specialized, evidence-grounded AI agents—each strictly constrained to medical device taxonomies, live knowledge graphs, and mandatory human review gates.

Open Interactive Agent Console Explore All 9 Agent Profiles
INTERACTIVE AGENT WORKSPACE

Explore Agent Reasoning & Execution Workflows

Select an agent to inspect its exact inputs, deterministic outputs, realistic prompts, multi-step execution pipeline, and mandatory human sign-off requirement.

SPECIALIZED AGENT #1 FDA 21 CFR 820.30 • ISO 13485 §7.3

Design Controls & Systems Engineering Agent

Enforces bidirectional traceability across User Needs, Design Inputs, Design Outputs, and Design Verification throughout the Design History File (DHF).

System Inputs Ingested
  • User Requirement Specifications (URS / PRS)
  • System Architecture Block Diagrams (SysML)
  • CAD Metadata & Component Part Revisions
Deterministic System Outputs
  • Traceability Matrix Coverage Reports (0 orphaned nodes)
  • Ambiguity & Testability Quality Scores (IEEE 830)
  • Automated Trace Link Proposals with Graph Hash
Realistic Prompt Question

"Identify all design inputs lacking bidirectional traceability to user need UN-042 (Ambulatory Wearable Skin Comfort) and score testability."

Human Oversight Requirement (Mandatory Gate)

Lead Systems Engineer and Quality Assurance Manager must formally execute 21 CFR Part 11 electronic signatures to commit any proposed trace link into the baseline DHF.

Sign-off Rule: 2-Person Dual Authorization Gate
Multi-Step Automated Reasoning Pipeline
1. Ingest Text Specification → 2. Parse Regulatory Entities → 3. Traverse Knowledge Graph → 4. Flag Traceability Gap → 5. Stage Sign-Off Docket
COMPLETE DIRECTORY

All 9 Domain-Specialized Intelligence Agents

Architected specifically for regulated life sciences. Zero generic conversational models; each agent operates on deterministic domain boundaries with cryptographically verified evidence trails.

Agent #1

Design Controls Agent

Enforces 21 CFR 820.30 & ISO 13485 bidirectional traceability across User Needs, Design Inputs, and Outputs.

Human Oversight: Systems Engineering Lead Dual Sign-off
Agent #2

Risk Management (ISO 14971)

Automates preliminary hazard identification, FMEA risk estimation, hazardous situations, and risk-benefit analyses.

Human Oversight: Risk Management Officer Signature
Agent #3

Regulatory Affairs Agent

Cross-references FDA, EU MDR, PMDA, and CDSCO rules to assess substantial equivalence and submission pathways.

Human Oversight: VP Regulatory Affairs Formal Review
Agent #4

Verification & V&V Agent

Audits test method rigor, statistical sampling plans, protocol execution data, and flags stale test evidence.

Human Oversight: Test Engineering Lead Test Witness
Agent #5

Clinical Evidence Agent

Appraises clinical literature, PMCF registries, and MAUDE data according to MEDDEV 2.7/1 Rev 4 guidelines.

Human Oversight: Chief Medical Officer CER Sign-off
Agent #6

Cybersecurity Agent

Monitors CycloneDX SBOMs, ingests NVD CVE feeds, and links buffer bugs to ISO 14971 patient hazards (IEC 81001-5-1).

Human Oversight: Head of Product Security Advisory Sign-off
Agent #7

Manufacturing Intelligence

Tracks SMT line yield, statistical Cpk drift, supplier lot CoAs, and enforces electronic DHR lot release holds.

Human Oversight: Manufacturing Quality Director MRB Approval
Agent #8

Post-Market Surveillance

Clusters real-world complaint tickets using IMDRF clinical adverse event NLP and correlates spikes with firmware/DHR lots.

Human Oversight: Quality Director Formal CAPA Initialization
Agent #9

AI Governance & GMLP

Enforces FDA Predetermined Change Control Plans (PCCP), monitors demographic bias parity, and tracks covariate drift.

Human Oversight: AI Ethics & Medical Algorithm Auditor