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 to navigate the complexities of the EUDAMED database.
**Expertise & scope**
* Assistance with UDI data validation, preparation, and uploads to meet MDR and IVDR requirements.
* Software solutions including M2M (Machine-to-Machine) and Bulk Upload capabilities for data submission.
* Services for checking EUDAMED SRN activity, validating GS1 Basic UDI & UDI DI for EUDAMED.
* Counterfeit monitoring to protect registrations from fraud by scanning UDI/Device modules weekly for unauthorized use of certificates or device identifiers.
* Training materials and self-paced courses designed to simplify EUDAMED requirements for devices and actor registration.
* Support for data exchange and access points, including M2M data and eDelivery access point integration.
* Vigilance MIR reporting to EUDAMED and other systems.
**Reputation / proof points**
* Services cover the EU market.
* Offerings include EudaMed+ (Silver/Gold/Platinum) and EudaMed Bronze (SaaS) software solutions.
EUDAMED Specialists provide comprehensive services focused on EUDAMED compliance for medical device manufacturers and importers. They offer software solutions, expert training, and direct assistance to navigate the complexities of the EUDAMED database.
**Expertise & scope**
* Assistance with UDI data validation, preparation, and uploads to meet MDR and IVDR requirements.
* Software solutions including M2M (Machine-to-Machine) and Bulk Upload capabilities for data submission.
* Services for checking EUDAMED SRN activity, validating GS1 Basic UDI & UDI DI for EUDAMED.
* Counterfeit monitoring to protect registrations from fraud by scanning UDI/Device modules weekly for unauthorized use of certificates or device identifiers.
* Training materials and self-paced courses designed to simplify EUDAMED requirements for devices and actor registration.
* Support for data exchange and access points, including M2M data and eDelivery access point integration.
* Vigilance MIR reporting to EUDAMED and other systems.
**Reputation / proof points**
* Services cover the EU market.
* Offerings include EudaMed+ (Silver/Gold/Platinum) and EudaMed Bronze (SaaS) software solutions.
Additional information
EUDAMED Specialists offer a range of software tools designed to streamline EUDAMED compliance. Their EudaMed+ platform provides automated submissions, UDI DI cloning, version control, and data management, supporting multiple companies and SRNs within a single database. For those needing to verify device data in EUDAMED, their EUDAMED Check service provides PDF and JSON reports of SRN submissions, offering proof of compliance and identifying missing UDI DIs. The EudaMed Monitor service offers weekly surveillance of EUDAMED's UDI/Device modules to detect potential fraud and unauthorized use of certificates or device identifiers, providing alerts for suspicious matches.
Key Highlights
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Provides automated EUDAMED submissions with UDI DI cloning and version control via EudaMed+ software.
Source
“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.”
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Offers a counterfeit monitor service that performs weekly surveillance of EUDAMED UDI/Device modules to detect fraud.
Source
“EudaMed “Counterfeit” Monitor is a weekly surveillance service built on EUDAMED – the EU’s central database for medical devices. Every week, we scan the UDI/Device modules of EUDAMED to ensure no one is illegally using your certificates or device identifiers.”
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Provides EUDAMED Check service to generate PDF and JSON reports of SRN submissions for proof of compliance.
Source
“Our EUDAMED Check service will provide you with PDFs and JSON data of all your SRN EUDAMED submissions, including monthly updates for any new additions.”
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Offers self-paced training courses simplifying 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, without being too technical.”
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 EUDAMED compliance for MDR/IVDR.
- Manufacturers and importers requiring UDI data submission support.
- Organizations seeking to monitor their EUDAMED presence for fraud.
How engagement typically works
- Software-as-a-Service (SaaS) for bulk uploads.
- Direct consultancy and project management.
- Self-paced online training modules.
- Automated monitoring and reporting services.
Typical deliverables
- EUDAMED compliance reports.
- Validated and prepared UDI data for submission.
- Automated data submission software.
- Fraud and counterfeit monitoring alerts.
- Training materials and certificates of completion.
Good to know
- Best when requiring specific tools and expertise for EUDAMED data management and compliance.
- Engagement may require understanding of MDR and IVDR regulations.
Pricing
Model:
Usage-based
Public range:
Publicly listed: €49.95–€1,995.00
Notes:
Pricing varies significantly based on the specific software solution or service package selected.
“Pricing: €0.00; €395.00; €995.00; €395.00; €695.00”
HQ:
Dublin, Ireland
Languages:
English
Timezones:
Europe/Brussels
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 involves selecting appropriate software or service packages, which may include training, data preparation, and direct submission support. Specific steps are detailed upon engagement with the service.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor, UDI/Devices, Vigilance
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Yes
Supports Clinical Investigations
false
