Ackomas provides a cloud platform that directly integrates with global medical device regulatory databases such as EUDAMED, GUDID, Swissdamed, and FDA to automate product registration submission and synchronization. The system offers real‑time alerts on regulatory changes, audit‑proof data storage on Azure, and a unified dashboard for compliance teams to monitor registration status across markets.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device manufacturers must submit and keep regulatory data synchronized across multiple global databases (EUDAMED, GUDID, Swissdamed, FDA, etc.), a process that is labor‑intensive, error‑prone, and difficult to monitor for regulatory changes.
Solution
Ackomas offers a cloud‑based platform that connects directly to major regulatory databases and automates the submission, synchronization, and updating of product registration data. The system eliminates manual spreadsheet work, provides real‑time alerts on regulatory updates, and ensures that all data is stored securely with audit‑proof logs. By integrating with existing IT environments, the platform delivers continuous market‑readiness and reduces compliance risk for multiple departments, from finance to IT security. Users can monitor compliance status through a unified dashboard, while the platform’s built‑in security and Azure‑backed infrastructure protect sensitive information.
Target Audience
Primary customers are regulatory affairs, quality, and compliance teams within medical device manufacturers that need to manage multi‑market product registrations and maintain continuous compliance.
Features
- Direct, API‑driven integration with EUDAMED, GUDID, Swissdamed, FDA and other global regulatory databases
- Automated data submission and synchronization that removes manual entry and reduces errors
- Real‑time regulatory change alerts and proactive update mechanisms
- Audit‑proof data storage with robust security controls hosted on Azure
- Unified dashboard providing visibility into compliance status across all product registrations
- Modular, scalable architecture that can be customized to fit existing IT systems and departmental workflows