EudaMed+ (Silver / Gold / Platinum)

Your EUDAMED data management solution for EUDAMED UDI submissions. EudaMed+ is designed by those who helped guide and manage the EUDAMED IT teams. Allow us to make your life easier. The Swiss Medic "SwissDaMed" and the FDA "GUDID" submissions are in the process of being added to our system.

EudaMed+ The EUDAMED Submission Solution

EudaMed+ (Silver / Gold / Platinum) and EudaMed Bronze (SaaS) overview infographic.


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Preparing and managing your data for EUDAMED submission is difficult and time-consuming, however, it does not have to be costly.

  • Unlimited UDI DIs and multiple SRNs are allowed.
  • Admin oversight for each of your multiple SRNs.
  • Exceptionally cost-effective, this costs a fraction of the price to create your own system.
  • Automated Data Submissions to the European Commission’s EUDAMED.
  • Safely manage your data on your servers.
  • User-level security access control.
  • Created by people who helped guide the European Commission EUDAMED project.
  • Add/Edit your data using user-friendly forms similar to EUDAMED.
  • Full version control and record locking options.
  • Validation and data upload reporting.
  • Reduce the time to add and collate data with useful clone DI functionality.
  • Reduce EUDAMED errors with full validation before your XML creation.
  • Your device data is validated on your servers before EUDAMED receives the data.
  • Creates the required XML for you, ready for EUDAMED submission.
  • Easy to use and navigate EudaMed+
  • Supported and maintained by us, the EUDAMED experts.
Software Functions/Options EudaMed Bronze EudaMed Silver EudaMed Gold EudaMed Platinum
Maximum UDI DIs allowed 2000 5000 8000 Unlimited
Unlimited Users
Validation of Client Data
Validation Error Reporting
Regulation/Directive specific templates
Import Template Data
PDFs of EUDAMED Prepared Data
Automated Data Validation
EUDAMED XML Preparation
Submission Progress Reporting
Software Support*
Premium Support*
Annual Subscriptions
Automated Email Status Reporting
Roadmap: Additional Regulatory Markets
UDI DI Package Limits
Automated EUDAMED Submissions
UDI Version Management
UDI DI Cloning
UDI DI Version Comparisons
Data Input Forms
Client Data Imports*
One SRN
Up to 5 SRNs for one company owner
Unlimited SRNs for one company owner
Unlimited UDI DIs
Exclusive Server
* Additional fees may apply

 

Full EUDAMED Service: Besides our EUDAMED data management & submission software we provide many EUDAMED services, attribute analysis, steering committee participation, premium support, and a complete EUDAMED project management service. We can assist you with the procedures and plans for managing EUDAMED in the future, for your user management and handling new or discontinued products. A complete EUDAMED service will allow your staff to continue with their day jobs uninterrupted, we manage the entire project for you.

We can help you at every point of this process from training to support, data preparation and processing, validation of the XML, consultancy, and uploads to the EUDAMED.

Let our EUDAMED expertise solve your EUDAMED problems.

Best in class EUDAMED submission, and data validation and preparation system.
Don’t just take our word for how good this is, contact us for an online free demo

 

Book a free introductory meeting to discuss your EUDAMED needs.