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 offer all-in-one compliance management tailored to specific needs.

**Expertise & scope**
* Seamless integration with EUDAMED for automated data synchronization, secure publication, and traceability.
* Expertise in EUDAMED modules including Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance, with upcoming Vigilance and Clinical Investigations modules.
* Guidance on UDI implementation, covering Basic UDI-DI, Master UDI-DI, UDI-DI, and UDI-PI.
* Support for MDR and IVDR compliance, ensuring market access and audit-readiness.
* Focus on data integrity and digital integration for regulatory automation.

**Reputation / proof points**
* Trusted by leading companies in the medical and pharmaceutical industries.
* Dedicated team available 24/7 for client success.

Additional information

ACKOMAS emphasizes that EUDAMED is a continuous regulatory process, not a one-off task. Their solutions aim to secure investments in technical documentation and Notified Body certification, protecting EU market access. They highlight that manufacturers relying on quick fixes may face increasing friction and rework. Their platform is designed to provide control, continuity, and predictability in regulatory operations. They also offer educational resources, including webinars and guides, to help manufacturers navigate EUDAMED requirements and deadlines.

Key Highlights

  • ACKOMAS provides 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.”
  • Their platform offers all-in-one compliance management tailored to client needs. Source
    “Our platform offers all-in-one compliance management tailored to your needs.”
  • ACKOMAS ensures seamless integration with EUDAMED for automated data synchronization and traceability. Source
    “ACKOMAS provides seamless integration with EUDAMED, allowing automated data synchronization, secure publication, and traceability, making regulatory operations more efficient.”
  • They offer guidance on EUDAMED modules, including Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance. Source
    “Actors (SRN): registration of all economic operators (manufacturers, authorized representatives, importers, SPP producers). The SRN becomes the prerequisite for any activity. UDI/Devices (UDI-DI): New devices: registration before first placing on the market (after 28 May 2026).”

Certifications & Trust Signals

  • Trusted by leading companies in the medical and pharmaceutical industries. Source
    “Trusted by leading companies in the medical and pharmaceutical industries.”
  • Their dedicated team is available 24/7 to ensure client success. Source
    “Our dedicated team is available 24/7 to ensure your success.”
  • ACKOMAS is 100% GDPR compliant. Source
    “ACKOMAS will never share your data with anyone outside the company—for marketing or any other purpose. 100% GDPR compliant.”

Buyer Snapshot

Best for
  • Medical device manufacturers needing EUDAMED integration.
  • Companies seeking automated regulatory compliance solutions.
  • Organizations requiring seamless data synchronization with EUDAMED and GUDID.
How engagement typically works
  • Provides comprehensive compliance management.
  • Offers ongoing support and educational resources.
  • Focuses on tailored solutions for specific needs.
Typical deliverables
  • Automated data synchronization with EUDAMED.
  • EUDAMED module integration and management.
  • UDI implementation strategies and support.
  • Regulatory automation for medical devices.
Good to know
  • Best when seeking long-term operational continuity and market access.
HQ: France
Languages: French, Italian
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 (upcoming), Clinical investigations / performance studies (upcoming)
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