EudaMed+ (Silver / Gold / Platinum)

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EudaMed+ The EUDAMED Submission Solution

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

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EudaMed+ Dashboard
Contact for more information.

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 Silver EudaMed Gold EudaMed Platinum
Maximum UDI DIs allowed.
Total allowed depends on the subscription band.		 5000 8000 20,000+*
Machine to Machine (M2M) ✔ ✔ ✔
Bulk Upload (automated) ✔ ✔ ✔
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* ✔ ✔ ✔
Up to 3 SRNs for one company owner ✔ ✔ ✔
Up to 8 SRNs for one company owner ✔
Up to 10 SRNs for one company owner ✔
100,000+ UDI DIs ✔
* Additional fees may apply
 
 

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