Global Submission Portal:
The New Era of Regulatory Compliance

A unified platform for global FDA and EUDAMED submissions is now available

Europe IT Consulting is pleased to announce the launch of the Global Submission Portal – a groundbreaking solution that simplifies and accelerates regulatory compliance processes for medical device manufacturers worldwide.

The Challenge

Medical device manufacturers face the complex task of registering and reporting their products to different authorities worldwide. Each authority has its own requirements, formats and processes. This leads to:

Zeitaufwändigen manuellen Prozessen
Time-consuming manual processes
High risk of errors during data entry
Lack of transparency regarding submission status
Fragmented workflows across multiple systems

The Solution: Global Submission Portal

Our Global Submission Portal integrates multiple submission workflows into a single, user-friendly platform. Manufacturers and regulatory teams can now transmit compliance-relevant data sets directly to authorities worldwide – efficiently, securely and transparently.

Core Functionality

The portal automates the entire submission process: from Excel-based data collection and automatic validation through to direct transmission to the authorities – all in one seamless workflow.

Supported Modules

The portal currently supports three critical compliance areas:

🇺🇸 FDA eMDR

Electronic Medical Device Reporting for fast FDA reporting

🇺🇸 FDA GUDID

Global UDI Database for US market registration

🇪🇺 EUDAMED UDI

EU MDR-compliant UDI submissions

Key Features in detail

Excel-based Upload

Simply upload your prepared Excel files. The system automatically recognizes the data structure and prepares the submission. No complex forms, no repeated data entry.

Validation Errors

For failed submissions, detailed validation errors are displayed, including the section, the exact XPath location and the specific authority message.

Real-time Status Tracking

Each submission passes through transparent status stages:

Uploaded – File uploaded, waiting for processing
Processing – Validation and transmission to the authority in progress
Success – Successfully accepted by the authority
Failed – Validation or submission failed

Comprehensive Download Options

After processing, all result files are available for download – either as a complete ZIP package or as individual reports. Authority responses (e.g. FDA ACK2) are displayed directly in the portal and are included in the ZIP archive.

Smart Notifications

Configure email notifications to be informed as soon as your submissions have been processed. Stay up to date without having to constantly check the portal.

Important Note on Data Availability

All files remain accessible for 6 months before they are automatically deleted. Make sure to download all required documents before this period expires.

Security and Compliance

The Global Submission Portal adheres to the highest security standards:

Encrypted data transmission (TLS/SSL)
Strict data isolation per customer
Access controls and user rights management
Audit trail for all activities
Regular security audits

Customizable Settings

Via the settings page, users can configure the portal according to their needs:

Look & feel and theme customization
Workflow preferences
Notification settings
Password management with “forgot password” function

Continuous Enhancement

The Global Submission Portal is continuously updated to support new regulatory requirements. Release notes and new features are communicated directly within the platform.

Planned enhancements include additional international authorities and further compliance modules to optimally support our customers worldwide.