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 is a dedicated provider of EUDAMAMED registration support services.
**Expertise & scope**
* Comprehensive services for EUDAMED compliance.
* Assistance with data submission processes.
* Provision of software solutions, including M2M and Bulk Upload capabilities.
* Expert training on EUDAMED requirements.
* Support for UDI data validation and preparation.
* Guidance on uploading UDI data to meet MDR and IVDR requirements.
**Reputation / proof points**
* Coverage across the EU.
* Services available in English.
EUDAMED Specialists is a dedicated provider of EUDAMAMED registration support services.
**Expertise & scope**
* Comprehensive services for EUDAMED compliance.
* Assistance with data submission processes.
* Provision of software solutions, including M2M and Bulk Upload capabilities.
* Expert training on EUDAMED requirements.
* Support for UDI data validation and preparation.
* Guidance on uploading UDI data to meet MDR and IVDR requirements.
**Reputation / proof points**
* Coverage across the EU.
* Services available in English.
Additional information
EUDAMED Specialists focuses on streamlining the complex process of EUDAMED compliance for manufacturers and economic operators. Their approach integrates software solutions with expert guidance to ensure accurate and timely data submission. Buyers can expect tailored support for UDI data, a critical component for MDR and IVDR adherence. The firm's expertise extends to training, empowering clients to manage their EUDAMED obligations effectively. Engagement typically involves understanding specific product portfolios and data structures to facilitate seamless integration with EUDAMED systems.
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 comprehensive EUDAMED registration support.
- Organizations requiring assistance with UDI data submission and validation.
- Businesses seeking expert training on EUDAMED compliance.
How engagement typically works
- Direct service provision for data submission.
- Software solution implementation.
- Expert consultation and training.
Typical deliverables
- Completed EUDAMED registrations.
- Validated UDI data sets.
- M2M and Bulk Upload software configurations.
- EUDAMED compliance training sessions.
Good to know
- Best when clients have MDR or IVDR regulated products requiring EUDAMED registration.
HQ:
Dublin, Ireland
Languages:
English
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
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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
Onboarding likely involves understanding client data, product scope, and UDI requirements for submission and validation.
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, potentially others depending on service scope.
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Likely, as part of overall compliance.
Supports Clinical Investigations
Likely, as part of overall compliance.
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