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.
* Development and implementation of software solutions for M2M and Bulk Upload.
* Expert training programs focused on EUDAMED requirements.
* Support for UDI data validation and preparation.
* Guidance on uploading 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.
* Development and implementation of software solutions for M2M and Bulk Upload.
* Expert training programs focused on EUDAMED requirements.
* Support for UDI data validation and preparation.
* Guidance on uploading data to meet MDR and IVDR requirements.
**Reputation / proof points**
* Coverage across the EU.
* Services available in English.
Additional information
EUDAMED Specialists focuses on ensuring clients meet the complex regulatory demands of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) through EUDAMED. Their approach includes validating and preparing Unique Device Identification (UDI) data, a critical step for device registration. They offer tailored software solutions designed to streamline the often-challenging M2M and Bulk Upload processes, facilitating efficient data submission. Beyond technical solutions, their expert training aims to equip clients with the knowledge needed to navigate EUDAMED independently. Engagement typically involves understanding specific device portfolios and data requirements to provide targeted support for obtaining the necessary registration numbers (SRNs) and fulfilling ongoing compliance obligations within the European Union.
Key Highlights
-
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.”
-
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.”
-
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”
-
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
-
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 comply with EUDAMED MDR/IVDR requirements
- Organizations seeking assistance with UDI data submission
- Businesses requiring EUDAMED training and software solutions
How engagement typically works
- Project-based support for specific EUDAMED tasks
- Consultative approach to compliance challenges
- Training and software implementation services
Typical deliverables
- EUDAMED registration support
- UDI data validation and preparation reports
- M2M and Bulk Upload software solutions
- EUDAMED training materials and sessions
Good to know
- Best when clients have devices subject to MDR or IVDR
- Best when clients require structured support for data submission and validation
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
Onboarding likely involves understanding specific device data, validation of UDI data, preparation for uploads, and potentially software solution implementation and training.
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
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Yes
Supports Clinical Investigations
false
⚡ Instant booking available
Book EU EUDAMED Actor & UDI Setup Support
Compare EUDAMED Specialists and other vetted providers — instant pricing, no RFQ needed.
