ACKOMAS
ACKOMAS provides automated regulatory compliance solutions for medical device manufacturers, specializing in seamless data synchronization with EUDAMED and GUDID for efficient market access and continuous compliance.
ACKOMAS is a leading provider of regulatory compliance solutions for medical devices, specializing in real-time data synchronization with global databases like EUDAMED, GUDID, and Swissdamed. Their platform simplifies complex regulatory processes, enhances data security, and ensures seamless, scalable compliance, helping manufacturers automate data management and maintain market readiness. With a focus on EUDAMED compliance, ACKOMAS offers solutions that streamline submissions, synchronize regulatory data worldwide, and provide real-time alerts for regulatory changes, minimizing risks and delays. They are trusted by manufacturers seeking control, continuity, and predictability in their compliance efforts, securing investments in technical documentation and certifications. ACKOMAS's expertise extends to UDI implementation, Master UDI-DI requirements, and ensuring data integrity through ALCOA+ principles. They offer tailored solutions, educational resources like guides and webinars, and robust M2M integrations to de-risk EUDAMED projects and ensure long-term operational continuity and market access under MDR/IVDR regulations.
About
**Who they are**
ACKOMAS provides automated regulatory compliance solutions for medical device manufacturers, specializing in seamless data synchronization with EUDAMED and GUDID for efficient market access and continuous compliance. They focus on simplifying regulatory processes, enhancing data security, and ensuring scalable compliance.
**Expertise & scope**
* Specializes in real-time data synchronization with EUDAMED, GUDID, and Swissdamed.
* Offers solutions for EUDAMED data governance, focusing on continuity and demonstrability.
* Addresses the alignment of Basic UDI-DI and UDI-DI, including historical data states.
* Provides guidance on EUDAMED compliance, including deadlines and module specifics.
* Supports manufacturers in preparing and validating EUDAMED submissions.
**Reputation / proof points**
* Trusted by regulatory and quality teams from medical device manufacturers across Europe.
ACKOMAS provides automated regulatory compliance solutions for medical device manufacturers, specializing in seamless data synchronization with EUDAMED and GUDID for efficient market access and continuous compliance. They focus on simplifying regulatory processes, enhancing data security, and ensuring scalable compliance.
**Expertise & scope**
* Specializes in real-time data synchronization with EUDAMED, GUDID, and Swissdamed.
* Offers solutions for EUDAMED data governance, focusing on continuity and demonstrability.
* Addresses the alignment of Basic UDI-DI and UDI-DI, including historical data states.
* Provides guidance on EUDAMED compliance, including deadlines and module specifics.
* Supports manufacturers in preparing and validating EUDAMED submissions.
**Reputation / proof points**
* Trusted by regulatory and quality teams from medical device manufacturers across Europe.
Additional information
ACKOMAS emphasizes structured traceability and demonstrability for EUDAMED compliance, which is crucial for regulatory inspections. They highlight that EUDAMED publication is a necessary condition for MDR and IVDR compliance, with key deadlines approaching. The company offers resources like webinars and guides to help manufacturers navigate the complexities of EUDAMED, particularly the UDI/Device module, which represents a significant operational load. Their approach aims to keep compliance efforts automated, efficient, and future-ready.
Key Highlights
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Specializes in real-time data synchronization with EUDAMED, GUDID, and Swissdamed.
Source
“specializing in real-time data synchronization with databases like EUDAMED, GUDID, and Swissdamed.”
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Focuses on EUDAMED data governance for continuity and demonstrability, including certificate-device linkage.
Source
“EUDAMED Continuity and Demonstrability as Structural Requirements”
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Provides resources and expertise for EUDAMED compliance, emphasizing the May 28, 2026 deadline.
Source
“La publication des données dans EUDAMED n’est plus une option : elle constitue désormais une condition nécessaire à la conformité des fabricants au MDR et à l’IVDR.”
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Offers a guide to simplify MDR & IVDR compliance, detailing EUDAMED modules and deadlines.
Source
“The essential guide to simplify MDR & IVDR compliance for medical device manufacturers”
Certifications & Trust Signals
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Trusted by regulatory and quality teams from medical device manufacturers across Europe.
Source
“Trusted by regulatory and quality teams from medical device manufacturers across Europe”
Buyer Snapshot
Best for
- Medical device manufacturers needing EUDAMED/GUDID data synchronization.
- Companies seeking to ensure regulatory continuity and demonstrability for EUDAMED.
How engagement typically works
- Consultative approach to clarify regulatory questions.
- Partnership for implementing operational EUDAMED compliance.
Typical deliverables
- Automated regulatory compliance solutions.
- EUDAMED data synchronization services.
- Guidance on UDI-DI and Basic UDI-DI strategy.
- Webinar and guide resources for EUDAMED compliance.
Good to know
- Best when manufacturers require structured data governance and traceability for EUDAMED.
HQ:
Amiens, France
Languages:
French, Italian
Claim status:
Listed
Services & Capabilities
EUDAMED M2M Integration
Pricing model:
Custom pricing
Supported Modules:
UDI/Devices, Certificates
Provides Access Point:
Yes
Additional eudamed_m2m Details
Supported Modules
UDI/Devices, Actor (implied)
