EudaMed Solution

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The EUDAMED Submission Solution

EudaMed+ Dashboard Overview.

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EudaMed+ Dashboard
Contact for more information.

Preparing and managing your data for EUDAMED submissions does not have to be costly. EudaMed+ is a cost-effective solution.

  • Exceptionally cost-effective, this costs a fraction of the price to create your own system.
  • XML creation for Manual Upload to the European Commission’s EUDAMED.
  • Machine to Machine (M2M) included as standard.
  • Automated Bulk Upload included as standard.
  • Created by people who helped guide the European Commission’s EUDAMED project.
  • Send your data to EudaMed vai API and JSON files OR using our spreadsheets templates, EudaMed+ validates, converts, and delivers XML to EUDAMED.
  • View your validated spreadsheet data in easy to read PDF’s, highlighting errors if they exist.
  • Reduce EUDAMED errors with full validation before your XML creation and data submission.
  • Your device data is validated before EUDAMED receives the data.
  • Creates the required EUDAMED XML for you.
  • 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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