Global Submission Portal: The New Era of Regulatory Compliance
Check out the video to get informed about the simple UDI submission process with our Global UDI Submission Portal
Unified platform for global FDA and EUDAMED submissions now available
Europe IT Consulting is pleased to announce the release of the Global Submission Portal – a revolutionary solution designed to simplify and accelerate regulatory compliance processes for medical device manufacturers worldwide.
The Challenge
Medical device manufacturers face the complex task of registering and reporting products to various authorities globally. Each authority has its own requirements, formats, and processes, leading to:
- Time-consuming manual processes
- High risk of error during data entry
- Lack of transparency regarding submission status
- Fragmented workflows across multiple systems
The Solution: Global Submission Portal
Our Global Submission Portal integrates several submission workflows into a single, user-friendly platform. Manufacturers and regulatory teams can now submit compliance-relevant datasets directly to authorities worldwide – efficiently, securely, and transparently.
Visit our dedicated GSP Landing Page
Are you looking for a solution specifically designed to handle high data volumes? On our specialized landing page, we show you how to efficiently scale and validate complex UDI submissions.
Core Functionality
The portal automates the entire submission process: from Excel-based data collection to automatic validation and direct transmission to the authorities – all in one seamless workflow.
Supported Modules
The portal currently supports four critical compliance areas:
- 🇺🇸 FDA eMDR: Electronic Medical Device Reporting for fast FDA notifications.
- 🇺🇸 FDA GUDID: Global UDI Database for US market registration.
- 🇪🇺 EUDAMED UDI: EU MDR-compliant UDI submissions.
- 🇪🇺 EUDAMED Vigilance: EU Manufacturer Incident Reports.
- AusUDID UDI: Australa UDI
- swissdamed UDI: Switzerland UDI
Key Features in Detail
Excel-Based Upload & High Data Volume
Simply upload your prepared Excel files. Our solution is explicitly designed for high volume, allowing thousands of records to be processed in the shortest possible time. The system automatically recognizes the data structure and prepares the submission.
GUDI – The SAP UDI Add-on for Global Compliance.
Compliance Deadlines: EUDAMED & swissdamed
Regulatory requirements are tightening: the mandatory use of EUDAMED for product registration is approaching. In Switzerland, the registration obligation via swissdamed is also already mandatory for many actors. Our portal helps you meet these deadlines safely through automated processes.
Validation Errors & Real-Time Status
In the event of failed transmissions, detailed validation errors are displayed. Each submission passes through transparent status phases: Uploaded, Processing, Success, or Failed.
Audit Trail
With the integrated Audit Trail, you always maintain a clear overview of all relevant activities within the Global Submission Portal. Every action is documented in a traceable manner, including date, time, user, authority, Primary DI, material number, action type and detailed information.
This makes it transparent when data has been uploaded, modified, deleted, exported or downloaded. It supports internal quality processes, facilitates the tracking of changes and provides a solid basis for audits and regulatory requirements.
Flexible filter functions allow audit entries to be searched specifically by period, user, Primary DI, material number, authority or action. In addition, compact key figures provide a quick overview of audit events, active users, affected materials and performed actions.
If required, the Audit Trail can be exported and is therefore also available for internal documentation, quality management or external inspections.
UDI Publication Report
The UDI Publication Report shows at a glance which UDI data has already been published with the respective authorities and where publication gaps still exist.
For each material or Primary DI, it is clearly displayed whether the data has already been published with EUDAMED, swissdamed, TGA AusUDID or FDA GUDID. This provides companies with a central overview of the global publication status of their UDI data.
Compact key figures show the number of managed UDI materials, the current publication coverage, the licensed authorities and existing publication gaps. Filter functions allow published records, open gaps or specific materials to be reviewed in a targeted manner.
The report supports Regulatory Affairs, Quality Management and project stakeholders in maintaining an overview of international UDI obligations and identifying open registration or publication steps at an early stage.
Security and Compliance
- Encrypted data transmission (TLS/SSL)
- Strict data isolation per customer
- Audit trail for all activities
Continuous Development
The Global Submission Portal is continuously updated to support new regulatory requirements. Planned expansions include additional international authorities and extra compliance modules.
Conclusion
With the Global Submission Portal, Europe IT Consulting offers a modern, efficient solution for the challenges of global regulatory compliance. Experience for yourself how the portal revolutionizes your workflows!
