EUDAMED System
Stil EUDAMED Management and Tracking System
EUDAMED is an information technology system developed by the European Commission for the implementation of Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices.
With the DataStil EUDAMED Management and Tracking System, you can easily manage all your EUDAMED processes.
What is EUDAMED? Why Is It Important?
EUDAMED (European Database on Medical Devices) is a central database established to ensure the traceability of medical devices placed on the market in the European Union. It is mandatory under the EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
Actor Registration
Manufacturer, authorized representative, and importer registrations
Device Registration
Medical device UDI and technical file information
Certificates
CE certificates and notified body information
Vigilance
Safety and performance reports
DataStil EUDAMED Management and Tracking System
Enables you to create templates according to the European Commission's MDR and IVDR EUDAMED data requirements, validate the generated data, and upload this data to the European Commission's EUDAMED.
The DataStil EUDAMED system prepares, validates, and sends EUDAMED templates for Distributor companies and EUDAMED templates for Importer companies.
EUDAMED Software
We manage and support your XML data preparation, XSD data validation, and data exchange processes within the scope of EUDAMED. At DataStil, we assist at every point of this process, from training to support, data processing (JSON, CSV, Excel, XML), XML validation, project management, to uploads.
With the DataStil EUDAMED Management and Tracking System, you can easily manage all your EUDAMED processes.
DataStil EUDAMED Features
XML Data Preparation
XML data preparation and formatting within the scope of EUDAMED.
XSD Data Validation
Data validation and compliance checking with XML schemas.
Data Exchange
Secure data exchange and synchronization with EUDAMED.
Training and Support
Comprehensive training and technical support for EUDAMED processes.
Data Processing
Data conversion and processing in JSON, CSV, Excel, XML formats.
MDR/IVDR Compliance
Full compliance with European Commission MDR and IVDR requirements.
Template Management
Custom EUDAMED templates for Distributor and Importer companies.
Automatic Upload
Automatic data upload and update to the EUDAMED database.
Project Management
Project management support for all EUDAMED processes.
EUDAMED System Advantages
- Mandatory compliance for EU market entry
- Time savings with automatic data transfer
- Ease of centralized data management
- Full compliance with regulatory requirements
- Market surveillance and transparency
Target Users
- Medical Device Manufacturers
- Authorized Representatives
- Importers and Distributors
- Notified Bodies
Get Information About EUDAMED Management System Now!
Fill out the form to get information about EUDAMED Management System software, and our customer representative will call you.
- Free Demo Opportunity
- Free Setup and Training
Our Expert Team Is By Your Side
Enter the EU market in a compliant manner with the EUDAMED Management System, simplify your EUDAMED processes.
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