EUDAMED Software

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We are the EUDAMED specialists.

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EUDAMED Software Solutions

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EudaMed+ Dashboard
Contact for more information.

EudaMed+ provides fully automated EUDAMED submissions of your validated device data, this includes time-saving UDI DI cloning functionality, version comparisons for you to see any differences easily, UDI DI version control and full data management of your data.

SwissDaMed data preparation is also available within EudaMed+, allowing you to upload validated data.

Suppose you have multiple companies and SRNs within your organisation. In that case, EudaMed+ will allow you to keep all data from all your companies within one powerful database, with fully automated EUDAMED submissions for each SRN, Machine to Machine and Bulk Uploads are included as standard, no extra charges.

EudaMed+ includes unlimited UDI DIs per SRN, unlimited users, and unlimited uploads to EUDAMED during your subscription. Contact for more information.

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

Full EUDAMED Service: In addition to our EUDAMED M2M and Bulk Upload data management & submission software, we provide many EUDAMED services, such as Vigilance MIR reporting to both EUDAMED and the MHRA MORE system, EudaMed Monitoring service for periodic checks as required for PRRCs, which saves your teams hours of searching EUDAMED to comply with the Post-Market Surveillance MD & IVDR requirements. This service monitors your registered certificates and UDIs weekly to ensure no company fraudulently uses your data or counterfeits your products.

Other services include attribute analysis, steering committee participation, premium support, and comprehensive EUDAMED project management. We can assist you with procedures and plans for managing EUDAMED in the future, including 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 in this process, from training and support to data preparation and processing, XML validation, consultancy, and uploads to EUDAMED.

Let our EUDAMED expertise solve your EUDAMED problems.

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Please subscribe to remain informed of any EUDAMED updates.

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