medical suite medelia
Discover the “DataBridge” module and directly connect your company to leading medical databases
The DataBridge module by MeDeLia simplifies the submission and synchronization of your data with major medical device monitoring databases, including EUDAMED (the European Commission’s information system), SwissDAMED (the Swiss database), and the FDA for the U.S. market.
Can’t find the database you need? Contact us—forget manual data uploads.
Contact usPOST-MARKET SOFTWARE
Why use DataBridge?
Regulatory compliance demands absolute precision.
In the increasingly complex landscape of medical device regulations, DataBridge is the smart, intuitive solution that lets you upload, manage, and synchronize your device data directly onto EUDAMED, SwissDAMED, FDA, and other international portals—without stress, without errors, without complications.
DataBridge Module
Workflow Simplification: Upload data to all portals without duplicating information.
Accuracy & Compliance: Automatic field validation to prevent errors and rejections, with full audit trails.
Reduced Time: Eliminate manual verification steps and optimize registration timelines.
Full Traceability: Monitor the status of your devices on every platform in real time.
Multilateral Support: Integration with EUDAMED, SwissDAMED, FDA, and future systems.
Intuitive Interface: Designed for users who aren’t regulatory experts—but still need to get the job done right.
AUTOMATIC GENERATION
Your data ready to upload
Simply select the device, and the system automatically generates files in the exact format required by EUDAMED, SwissDAMED, FDA, and other portals.
Prepare everything in advance so you can upload your data with simplicity, security, and precision.
CERTIFICATES & NOTIFIED BODIES
Not just devices — but also certificates
Every device is not just a product — it’s a regulated item, with certificates, risk classes, and notified bodies that ensure its compliance.
DataBridge lets you map each device to its certificate and view its full status in one centralized dashboard: everything under control.
AUDIT TRAIL & SECURITY
Every transmission is tracked, every version is saved
Every time you upload or modify data, the system logs everything: who did what, when, and what changed.
It’s not just a log — it’s your proof that you did everything correctly.
Because when an audit arrives, you don’t have to remember anything — the system shows you exactly what you did, when, and with which version.
The electronic IFU management system developed by RealBit has been very useful for our company as it has enabled much easier and more systematic management of instructions for use. The program allows you to keep all document revisions under control, enabling management by language, products and countries of interest. It should also be emphasized that the program is continuously evolving thanks to updates that allow it to respond to regulatory requirements and the needs of customers who use it, in order to always be up-to-date with the times. Very important is also the customer assistance, always present and ready to respond to every request and need. Recommended!
Before adopting Medelia, at Intrauma we relied on free tools like Google Forms for managing post-market surveillance and clinical follow-up. These solutions, although immediate, did not guarantee adequate protection of the privacy of collected data and left room for errors or uncontrolled completions, with the risk of skewing results. The introduction of Medelia in our company reality has marked a clear step change: the interface is intuitive and well organized, and the data collection and analysis processes have been significantly simplified, allowing us to optimize the entire operational workflow related to PMS and PMCF, improving productivity and reducing response times.
Maximum Flexibility
Available in Cloud and On-Premise Versions
MEDELIA (and its modules eIFU, PMS, and DataBridge) in the cloud is hosted on RealBit servers compliant with medical industry regulations and designed to ensure high reliability with continuous backups. But we also give you maximum freedom — you can install the suite on your own company servers.
Choose Cloud for maximum scalability and security.
Choose On-Premise for maximum customization.
Smart software for your business!
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