EUDAMED Specialists
EUDAMED Specialists provide comprehensive services for EUDAMED compliance, including data submission, software solutions (M2M & Bulk Upload), and expert training. They assist with UDI data validation, preparation, and uploads to meet MDR and IVDR requirements.
EUDAMED Specialists are dedicated to helping businesses navigate the complexities of the EUDAMED database. They offer a full suite of services designed to ensure compliance with European Commission regulations such as MDR and IVDR, with a mandatory deadline of May 28, 2026. Their offerings include robust software solutions like EudaMed+ and EudaMed Bronze (SaaS) for M2M and bulk data uploads, simplifying the submission process. These tools facilitate UDI data validation, preparation, and automated uploads, including features for UDI DI cloning, version control, and data management. They also support integrations with SwissDaMed and AusUDID. Beyond software, EUDAMED Specialists provide extensive training programs tailored for IT teams, management, and RA/QA professionals. These training sessions cover EUDAMED requirements, data structures, XML, and best practices. Consultancy services are also available for project management, attribute analysis, and developing future EUDAMED management strategies. Furthermore, their EUDAMED Check service offers critical tools for importers and manufacturers to verify UDI DI presence in EUDAMED, obtain certified proof of submissions, and identify missing data. This service helps ensure legal obligations are met and provides valuable competitor analysis capabilities.
About
**Who they are**
EUDAMED Specialists provide comprehensive services focused on EUDAMED compliance for medical device manufacturers and importers. They offer software solutions, expert training, and direct assistance with data submission and validation.
**Expertise & scope**
* Assistance with UDI data validation, preparation, and uploads to meet MDR and IVDR requirements.
* Software solutions for M2M (Machine-to-Machine) and Bulk Uploads, including data management, version control, and automated submissions.
* EUDAMED Check service for validating UDI DIs and obtaining certified proof of their existence in EUDAMED.
* EudaMed Monitor for weekly surveillance of EUDAMED to detect fraudulent use of certificates or device identifiers.
* Training materials and self-paced courses designed to simplify EUDAMED requirements for various professional roles.
* Support for data exchange and access point integration.
**Reputation / proof points**
* Services cover the EU market.
* Offer support in English.
EUDAMED Specialists provide comprehensive services focused on EUDAMED compliance for medical device manufacturers and importers. They offer software solutions, expert training, and direct assistance with data submission and validation.
**Expertise & scope**
* Assistance with UDI data validation, preparation, and uploads to meet MDR and IVDR requirements.
* Software solutions for M2M (Machine-to-Machine) and Bulk Uploads, including data management, version control, and automated submissions.
* EUDAMED Check service for validating UDI DIs and obtaining certified proof of their existence in EUDAMED.
* EudaMed Monitor for weekly surveillance of EUDAMED to detect fraudulent use of certificates or device identifiers.
* Training materials and self-paced courses designed to simplify EUDAMED requirements for various professional roles.
* Support for data exchange and access point integration.
**Reputation / proof points**
* Services cover the EU market.
* Offer support in English.
Additional information
EUDAMED Specialists offer a range of software tools designed to streamline EUDAMED compliance. Their EudaMed+ platform supports automated submissions, UDI DI cloning, version comparisons, and full data management. For organizations with multiple companies and SRNs, EudaMed+ allows centralized data management with automated submissions for each SRN. Machine-to-Machine (M2M) and Bulk Uploads are standard features. They also provide Vigilance MIR reporting and a monitoring service to assist PRRCs with Post-Market Surveillance requirements by tracking registered certificates and UDIs weekly for potential misuse or counterfeiting.
Key Highlights
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Provides a EudaMed Monitor service for weekly surveillance of EUDAMED to detect fraudulent use of certificates or device identifiers.
Source
“EudaMed “Counterfeit” Monitor is a weekly surveillance service built on EUDAMED – the EU’s central database for medical devices.”
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Offers EUDAMED Check service to validate UDI DIs and provide certified proof of their existence in EUDAMED.
Source
“We provide you with a report certifying the requested UDI DIs are in EUDAMED.”
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EudaMed+ software supports automated EUDAMED submissions, UDI DI cloning, version comparisons, and full data management.
Source
“EudaMed+ provides fully automated EUDAMED submissions of your validated device data, this includes time-saving UDI DI cloning functionality”
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Provides self-paced training courses covering EUDAMED requirements for device data submissions and actor registration.
Source
“Our exclusive “EUDAMED Simplified” training teaches you all the EUDAMED requirements for both the Device data submissions and the actor registration for your SRN”
Certifications & Trust Signals
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Focuses on EUDAMED compliance for MDR and IVDR requirements.
Source
“Audience: RAs, QAs, IT, Management, MDR and IVDR Consultants, and people interested in EUDAMED.”
Buyer Snapshot
Best for
- Companies needing to ensure UDI data is correctly submitted and validated in EUDAMED.
- Organizations seeking automated solutions for EUDAMED data uploads and monitoring.
- Manufacturers and importers requiring proof of EUDAMED compliance for MDR/IVDR.
How engagement typically works
- Software subscription for EudaMed+ platform.
- Direct service provision for data validation and submission.
- Training courses and educational materials.
Typical deliverables
- EUDAMED compliance reports.
- Automated UDI data submission via M2M or Bulk Upload.
- Weekly EUDAMED monitoring alerts.
- Training certificates.
- PDF and JSON data of SRN EUDAMED submissions.
Good to know
- Best when requiring specific support for EUDAMED MDR/IVDR compliance.
- Best when leveraging software solutions for data management and submission.
Pricing
Model:
Usage-based
Public range:
Publicly listed: €49.95–€1,495.00
Notes:
Pricing varies based on specific software packages and training modules.
“Pricing: €0.00; €395.00; €395.00; €695.00; €495.00”
HQ:
Dublin, Ireland
Languages:
English
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
DE, IE, NL, FR, PL, AT
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–21 days
Pricing model:
Usage-based
Starting from:
EUR 1,200
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Vigilance
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
eudamed_onboarding_support
eudamed_m2m
Jurisdictions:
EU
Countries:
DE, FR, GB
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Assistance with data submission, validation, preparation, and uploads.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
UDI/Devices, Actor Registration (SRN)
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Yes
Supports Clinical Investigations
false
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