Your Fast Track to EUDAMED Compliance
A fully managed service by Asphalion that simplifies your EUDAMED submissions — no license, no subscription, no hassle.
EUDAMED KEY DATES
March 2026
New products
May 28, 2026
Already existing products
AsphaEudaMate
AVAILABLE NOW
Avoid errors. Save time. Stay compliant.
AsphaEudaMate is a Machine-to-Machine (M2M) Massive upload tool integrated into the Data Exchange (DTX) M2M system, this option allows for automatic data exchange between an external backend system and EUDAMED backend services (in bulk as well).
With this Asphalion customized built application, our team is able to directly connect with EUDAMED DTX service and with a simple completed spreadsheet we can massively upload all your UDIs in a single step, without the need to enter any data manually in the EUDAMED interface.
- Machine-to-Machine (M2M) Massive upload tool.
- End-to-end support: from spreadsheet to XML upload
- No need for expensive external tools
- Fully compliant with EUDAMED data structure
- Fixed-price packages tailored to your UDI volume
- Optional discounted data entry and validation services
- No recurring fees — updates only when needed
- Designed and operated by MedTech regulatory experts
EUDAMED Challenges
New Challenge
- Time consuming and repetitive task
- Specific format
- In-house development with several phases of automation
- Depending on external tools (very high cost)
Asphalion Solutions
- Data entry at a special discounted hourly rate
- Developed by Asphalion: Spreadsheet compliant with EUDAMED fields
- Developed and managed by Asphalion as a Service, no license or subscription required
- Once the first upload is done, updates are performed only if needed at a fixed rate
Calculate how much time, money and resources you can save
With AsphaEudaMate, you can save up to 72% of your time, competing your tasks in 14 hours instead of in 50 hours.
AsphaEudaMate Solutions
AsphaEudaMate FULL
- All activities performed by Asphalion:
- Data entry
- Transcription to XML
- EUDAMED data validation checks
- Massive first bulk upload through our customized Machine-to-Machine (M2M) Data Exchange (DTX) interface
AsphaEudaMate LITE
- Excel File: personal and non-transferable (legal binding). Prepared by Asphalion and shared with Client
- Transcription to XML- Performed by Asphalion
- EUDAMED data validation checks- Performed by Asphalion
- Massive first bulk upload through our customized Machine-to-Machine (M2M) Data Exchange (DTX) interface
AsphaEudaMate KEEP
- Fixed Fee
- On request, no monthly payment
- Special discounted hourly rate for EUDAMED data entry and data validation checks
Schedule now a free meeting with our EUDAMED experts!
Tell us about your project, challenges or doubts. We will be happy to assist you!
Why Asphalion?
ASPHALION offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages
ASPHALION’s experts have delivered solutions to over 1,500 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 10,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.
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