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.
**Expertise & scope**
* Specializes in real-time data synchronization with EUDAMED, GUDID, and Swissdamed.
* Focuses on simplifying regulatory processes, enhancing data security, and ensuring scalable compliance.
* Offers solutions for structured traceability and demonstrability of regulatory data, including device-certificate linkage and Basic UDI-DI/UDI-DI alignment.
* Provides guidance and support for EUDAMED compliance, particularly concerning the UDI/Devices module and upcoming deadlines.
* Assists manufacturers in preparing and validating EUDAMED submissions and clarifying specific EUDAMED requirements.
**Reputation / proof points**
* Trusted by regulatory and quality teams from medical device manufacturers across Europe.
* Clients consistently highlight reliability, reduced internal effort, and peace of mind.
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.
**Expertise & scope**
* Specializes in real-time data synchronization with EUDAMED, GUDID, and Swissdamed.
* Focuses on simplifying regulatory processes, enhancing data security, and ensuring scalable compliance.
* Offers solutions for structured traceability and demonstrability of regulatory data, including device-certificate linkage and Basic UDI-DI/UDI-DI alignment.
* Provides guidance and support for EUDAMED compliance, particularly concerning the UDI/Devices module and upcoming deadlines.
* Assists manufacturers in preparing and validating EUDAMED submissions and clarifying specific EUDAMED requirements.
**Reputation / proof points**
* Trusted by regulatory and quality teams from medical device manufacturers across Europe.
* Clients consistently highlight reliability, reduced internal effort, and peace of mind.
Additional information
ACKOMAS emphasizes that EUDAMED compliance is an ongoing process, not a one-off task. They highlight that market access depends on the ability to publish, update, and justify regulatory data over time. Manufacturers relying on quick fixes may experience friction and rework. ACKOMAS aims to secure investments in technical documentation and Notified Body certification, protecting EU market access for high-risk devices. They offer educational resources, including webinars and guides, to help manufacturers navigate EUDAMED requirements and deadlines, such as the mandatory use of EUDAMED modules starting May 28, 2026.
Key Highlights
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Specializes in automated regulatory compliance solutions for medical device manufacturers.
Source
“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.”
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Focuses on seamless data synchronization with EUDAMED, GUDID, and Swissdamed.
Source
“ACKOMAS is a leading provider of regulatory compliance solutions for medical devices, specializing in real-time data synchronization with databases like EUDAMED, GUDID, and Swissdamed.”
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Ensures structured traceability and demonstrability of regulatory data, including device-certificate linkage.
Source
“Regulatory continuity requires structured traceability. Structured Governance Enables EUDAMED Continuity; Explicit Certificate ↔ Device Linkage;”
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Provides support for EUDAMED compliance, emphasizing the mandatory nature of data publication from May 28, 2026.
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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Assists manufacturers in understanding and managing the UDI/Devices module, which represents a significant operational load.
Source
“Le module Dispositifs / UDI concentre la charge principale”
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;”
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Clients highlight reliability, reduced internal effort, and peace of mind.
Source
“Clients consistently highlight reliability, reduced internal effort, and peace of mind.”
Buyer Snapshot
Best for
- Medical device manufacturers needing to comply with MDR/IVDR.
- Companies seeking to automate regulatory compliance and data synchronization with EUDAMED.
- Organizations requiring structured data governance and traceability for regulatory submissions.
How engagement typically works
- Consultative approach to understand client's regulatory context.
- Focus on providing practical solutions and expert guidance.
- Support for operational implementation of EUDAMED.
Typical deliverables
- EUDAMED data synchronization solutions.
- Regulatory compliance frameworks.
- Guidance on UDI-DI and Basic UDI-DI strategy.
- Support for EUDAMED submission preparation and validation.
Good to know
- Best when manufacturers are preparing for or actively managing EUDAMED compliance.
- Most effective for companies that value data integrity and continuous regulatory alignment.
HQ:
France
Languages:
French, Italian
Claim status:
Listed
Services & Capabilities
EUDAMED M2M Integration
Pricing model:
Custom pricing
Supported Modules:
Actor, UDI/Devices, Certificates
Provides Access Point:
Yes
Additional eudamed_m2m Details
Supported Modules
Actor, UDI/Devices, Notified Bodies & Certificates, Market Surveillance, Vigilance, Clinical investigations / performance studies
