PMX OS does not replace your systems of record. It connects PLM, QMS, ALM, ERP, CAD, and Clinical EDC into a unified, mathematically verifiable knowledge layer.
A non-destructive, bidirectional architecture that continuously harmonizes engineering changes with regulatory baselines.
Extracts typed entities: Components, Requirements, Hazards, Tests, Clearances. Reconciles revisions without database migrations.
21 CFR Part 11 Audit TrailPre-built connector templates and open GraphQL/REST API bridges for all modern MedTech infrastructure.
Ingests Multi-Level Engineering BOMs (EBOM), Manufacturing BOMs (MBOM), CAD part geometries, and formal engineering change notices (ECN).
Bi-directional synchronization of CAPA records, Deviation reports, Non-Conformance reports (NCR), training matrices, and SOP document approvals.
Binds firmware pull requests, software tickets, and automated test runners to Design Controls (IEC 62304) and system verification protocols.
Monitors supplier quality certificates, plant-specific component obsolescence notices, batch lots, and UDI serial number allocations.
Extracts PCB schematic netlists, electrical dissipation values, and 3D enclosure models to verify physical standards limits (e.g. IEC 60601-1-11).
Ingests post-market surveillance telemetry, clinical trial endpoints, and regulatory vigilance databases to close the loop on risk matrices.
Request an architecture consultation to review your organization's IT topology, API requirements, and deployment model (Private Cloud or Hybrid On-Premise).