In automotive or aerospace engineering, a digital twin models 3D CAD meshes and finite-element stress analysis. In medical devices, physical geometry is only the outer shell. PMX OS introduces the Regulatory & Lifecycle Intelligence Twin: a synchronized semantic graph that unites physical configuration, embedded firmware binaries, risk matrices, verification evidence, supplier qualifications, clinical claims, and change history into a unified source of truth.
When product engineering teams invest in "Digital Twins," they almost universally adopt mechanical CAD tools, aerodynamic flow solvers, or thermal finite-element simulators. While invaluable for evaluating whether an enclosure can survive a 1-meter drop test, these geometric models are blind to the realities that dictate whether a medical product can legally and safely treat patients.
A 3D CAD model does not know if its microcontroller firmware has a high-severity buffer overflow (CVE-2024-8121). It cannot tell you whether a change in a thermistor’s supplier will trigger an FDA Special 510(k) submission. It cannot verify whether an updated clinical claim is supported by statistical evidence from multi-center trial CS-088.
The PMX Regulatory & Lifecycle Intelligence Twin bridges this critical gap. It does not replace physical engineering files; it wraps them in a living semantic fabric where every resistor, firmware loop, risk mitigation, and supplier certificate is an addressable, cryptographically validated entity.
| Dimension | Physical Digital Twin | PMX Regulatory Lifecycle Twin |
|---|---|---|
| Core Representation | 3D geometric solid, mesh vertices, stress tensors | Knowledge graph: requirements, hazards, evidence, code, claims |
| Governing Standard | ASME Y14.5 (GD&T), ISO 10303 (STEP) | FDA 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, EU MDR |
| Change Velocity | Infrequent; revised during major mechanical tooling ECOs | Continuous; updated daily with code commits, complaints, supplier CoA |
| Audit Grounding | Engineering simulation log files (.rst, .fem) | Immutable SHA-256 evidence records with human Part 11 signatures |
| Impact Query Scope | "Does Part A collide with Part B under 50°C expansion?" | "What 23 objects, risks, submissions, and tests break if Supplier Y alters S-18?" |
In PMX OS, every product entity has an unambiguous lifecycle state, ownership metadata, and cryptographic verification hash:
Use the AI Command Center (Ctrl + K) to ask complex multi-hop questions directly against the CardioSense Pro digital twin.
Select any subsystem layer to reveal its real-time twin state, linked requirements, verified evidence records, and active engineering change tickets.
Primary continuous skin temperature measurement channel powered by analog thermistor Sensor S-18 (Supplier Y). Governed by hardware specification SPEC-HW-409 and PCB layout Rev 3.2. Sits adjacent to the photoplethysmography (PPG) optical sensor.
EV-TRC-1024 (sha256:4f8a...99b1)