Overview
Small medical device manufacturers face the same compliance obligations as large ones — but without the IT infrastructure or budget. Off-the-shelf software rarely fits the specific intersection of FDA QSR, ISO 13485, UDI, and training requirements. Mansour Consulting has built and deployed an integrated compliance platform that addresses all of these needs in a single, connected environment.
Platform Components
The platform integrates four proven open-source and commercial systems, configured and connected specifically for regulated medical device environments.
- ERP system — manufacturing, inventory, procurement, and financials with QSR-aligned workflows
- Document Management System (DMS) — controlled document lifecycle, revision control, electronic signatures, and audit trails
- Learning Management System (LMS) — ISO 13485-aligned training management, competency tracking, and automated completion records
- Label Management — UDI-compliant label design, printing, and data integration with GUDID/EUDAMED
Why an Integrated Platform?
The most common compliance gap in small device companies is fragmentation — documents in one system, training records in another, label data in a spreadsheet, and inventory in QuickBooks. An integrated platform eliminates these silos.
- Single source of truth for product, document, and training data
- Automated linkage between document changes and training assignments
- Label data pulled directly from ERP — no manual re-entry
- UDI data synchronized with labeling and quality records
- Audit-ready records with full traceability
The platform is designed for companies with 5–100 employees — sized right for your operation, not a Fortune 500 enterprise.
Implementation & Support
We handle the full implementation, configuration, and validation of the platform — including IQ/OQ/PQ documentation if required by your quality system.
- System requirements and user needs definition
- Configuration and customization for your workflows
- Data migration from legacy systems
- Computer system validation (CSV) and V&V documentation per ISO 13485
- User training and go-live support
- Ongoing system administration and updates
UDI & Labeling Integration
The labeling and UDI components are particularly valuable for manufacturers managing GUDID and EUDAMED compliance across multiple device families.
- Label templates with live ERP data connections
- UDI barcode generation (GS1-128, DataMatrix, QR)
- GUDID data export from ERP master data
- EUDAMED XML batch file generation
- Label approval workflow within the DMS