ACKOMAS – Your Trusted Partner in Global Medical Device Data Compliance

ACKOMAS empowers medical device manufacturers, regulatory teams, and compliance professionals with automated solutions to streamline regulatory processes across multiple international regulations.

Our cutting-edge SaaS platform ensures seamless compliance with key regulatory databases, including: EUDAMED (Europe), SWISSDAMED (Switzerland), GUDID (USA – FDA), SFDA (Saudi Arabia), MHRA (UK), TGA (Australia), HC (Health Canada), NMPA (China).

Why Choose ACKOMAS?

✔ Automated UDI Management – Direct M2M integration with Global Regulatory Databases

✔ Real-Time Data Synchronization – Stay compliant with evolving regulations

✔ Intuitive & Scalable Platform – Designed for seamless adoption by teams of all sizes

✔ Guaranteed Compliance – MDR, IVDR, FDA 21 CFR Part 820, and ISO 13485 ready

From UDI registration to audit readiness, we help you achieve full compliance with confidence.