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 and enhancing data security.
**Expertise & scope**
* Automated regulatory compliance solutions for medical devices.
* Seamless data synchronization with EUDAMED, GUDID, and Swissdamed.
* Ensuring continuous compliance and efficient market access.
* Simplifying regulatory processes and enhancing data security.
* Focus on EUDAMED data governance, continuity, and demonstrability.
* Guidance on EUDAMED modules, UDI system mastery, and implementation strategies.
* Addressing EUDAMED deadlines and transition periods, including for legacy devices.
**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 and enhancing data security.
**Expertise & scope**
* Automated regulatory compliance solutions for medical devices.
* Seamless data synchronization with EUDAMED, GUDID, and Swissdamed.
* Ensuring continuous compliance and efficient market access.
* Simplifying regulatory processes and enhancing data security.
* Focus on EUDAMED data governance, continuity, and demonstrability.
* Guidance on EUDAMED modules, UDI system mastery, and implementation strategies.
* Addressing EUDAMED deadlines and transition periods, including for legacy devices.
**Reputation / proof points**
* Trusted by regulatory and quality teams from medical device manufacturers across Europe.
Additional information
ACKOMAS emphasizes structured governance and traceability as key to EUDAMED continuity. They highlight that regulatory inspections may require structured demonstration of alignment, traceability, and historical data states. This includes ensuring certificate-device coherence and the ability to retrieve specific data states at particular dates without reconstruction. Their approach aims to make compliance automated, efficient, and future-ready, particularly as EUDAMED becomes a mandatory condition for market compliance under MDR and IVDR.
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, continuity, and demonstrability.
Source
“EUDAMED Continuity and Demonstrability as Structural Requirements”
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Provides guidance on EUDAMED deadlines, including the May 28, 2026 application date.
Source
“À partir du 28 mai 2026, tout dispositif mis sur le marché devra être enregistré dans EUDAMED avant sa commercialisation.”
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Offers a guide to simplify MDR & IVDR compliance, covering EUDAMED fundamentals and UDI system mastery.
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 compliance.
- Companies seeking automated regulatory data synchronization.
- Organizations requiring demonstrable regulatory continuity.
How engagement typically works
- Structured discussion on regulatory context.
- Validation of EUDAMED or UDI approach.
- Assessment of current setup against EU requirements.
Typical deliverables
- EUDAMED data synchronization solutions.
- Regulatory continuity frameworks.
- UDI-DI and Basic UDI-DI alignment strategies.
- Timestamped publication records.
- Guides and resources for EUDAMED compliance.
Good to know
- Best when requiring a structured approach to EUDAMED data governance and traceability.
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
UDI/Devices, Actor, Vigilance, Clinical Investigations (implied by EUDAMED context)
