Tier-1 MedTech manufacturers manage hundreds of device families across conflicting regional jurisdictions. PMX OS overlays your existing PLM, ERP, and QMS infrastructure to instantly quantify regulatory exposure when components change or global standards shift.
Supply chain obsolescence in medical technology is not an inventory problem—it is a cross-jurisdiction regulatory emergency.
Decades of corporate acquisitions leave global manufacturers with heterogeneous stacks: Teamcenter in cardiac, Windchill in orthopedics, SAP globally, and multiple local quality systems.
A component modification deemed a simple "Letter to File" in the US may constitute a "Substantial Modification" under EU MDR Article 120 or trigger an 18-month partial review with PMDA Japan.
Notified Bodies (BSI, TÜV SÜD, DEKRA) conducting annual surveillance audits demand complete, uncompromised traceability between design baselines and manufacturing records across all sites.
Enterprises cannot afford multi-year, nine-figure "rip-and-replace" IT migrations. PMX OS sits directly atop your operational systems of record:
How PMX OS evaluates Change Request CHG-1024 across primary global regulatory authorities:
| Jurisdiction | Classification | Required Filing Pathway |
|---|---|---|
| United States (FDA) | Class II (510k) | Letter-to-File (REQ-0184 verified) |
| European Union (MDR) | Class IIb (CE) | Article 120 Assessment (NB Review) |
| Japan (PMDA) | Class II (Shonin) | Minor Modification Notice |
| Canada (Health Canada) | Class III (MDL) | Annual Notification Update |
Traced across 3 manufacturing sites (Minneapolis, Galway, Singapore) and 12 registered markets.
The global procurement team flags that supplier Y has discontinued thermistor S-18. In the ERP system, S-18 is linked to finished good assembly ASM-9022 (CardioSense Pro v3.8.2).
Without PMX OS, regulatory managers in each region would spend 4–6 weeks independently pulling down regional registration binders, requesting CAD drawings from Windchill, and conducting uncoordinated risk assessments.
| Enterprise Dimension | Disconnected Legacy Environment | PMX OS Connected Knowledge Graph |
|---|---|---|
| Change Scoping Time | Weeks of manual document searches across Windchill, SAP, and PDFs | Instant deterministic blast radius traversal across all product trees |
| Cross-Border Filing Accuracy | High risk of regional divergence and unnotified market shipments | Synchronized multi-jurisdiction regulatory decision trees and filing guidance |
| Notified Body Audit Prep | 3–4 weeks of manual document gathering and trace matrix remediation | Push-button, cryptographically verified audit package generation |
| Supply Chain Downtime Risk | Production holds due to delayed regulatory sign-offs on component swaps | Continuous verification of alternate components before supply disruption hits |
Empower your cross-functional engineering, quality, and regulatory organizations with a single shared truth.