ABOUT ACKOMAS
Compliance used to be one database. Now it's many — and still multiplying.
ACKOMAS was built by regulatory professionals who watched device data scatter across EUDAMED, GUDID, Swissdamed, SFDA, AusUDI and more — each base with its own format, deadlines and logic. We exist to turn that fragmentation into one governed source, mapped to every regulator.
WHERE WE COME FROM
Founded by regulatory professionals
People who lived MedTech compliance from the inside.
20+ years in traceability & compliance
A field we helped shape since the first unit-level systems.
Trusted around the world
From SMEs to large manufacturers, on every continent.
Aligned with the authorities
Built around FDA, EU MDR/IVDR, Swissmedic, TGA, ANVISA and more.
Our promise — we turn compliance into competitive edge
IN ONE SENTENCE
ACKOMAS is a regulatory data governance platform that lets medical device manufacturers manage UDI compliance across EUDAMED, GUDID, Swissdamed, SFDA, AusUDI and more — from one governed source of truth.
WHY WE EXIST
One database already breaks you. Five is impossible.
EUDAMED alone is already a battle: data you can't edit, records deleted one by one, a portal that crawls. Now multiply that across every regulator on earth — parallel bases, each with its own format and deadlines. ACKOMAS was built for exactly that.
The corner-of-a-desk illusion
Teams tried to run compliance on a spreadsheet and one portal. But even a single base — EUDAMED — means non-editable data, records deleted one by one, and a portal that crawls.
Then the bases multiplied
GUDID, Swissdamed, SFDA, AusUDI and more — each regulator now runs its own database, format and cadence. Most manufacturers are still mid-way on every one of them.
Manual re-keying breaks
Typing the same device data into every portal doesn't scale. That's where errors, missed deadlines and audit risk quietly accumulate.
THE MANUAL WAY
Same device data, re-entered by hand into every portal.
WITH ACKOMAS
Entered once, mapped to every regulator.
Your device data — one governed source
mapped to each base
OUR CONVICTION
Enter your data once. Publish it everywhere.
One governed source of truth, mapped to each regulator's format. Whether you manage one base or five, the data is entered once — then ACKOMAS keeps every database in sync, at your perimeter and your pace.
YOUR DEVICE DATA
One governed source of truth
WHO WE ARE
The people who saw this coming
ACKOMAS was founded by regulatory professionals who lived the compliance burden from the inside — and built the system they wished they had.
20+ years of expertise
Founded by professionals who lived MedTech compliance from the inside — practitioners, not observers.
Trusted around the world
From SMEs to large manufacturers, on every continent — not just Europe.
Aligned with authorities
Built around the authorities that matter: FDA, the European Commission (EU MDR/IVDR), Swissmedic, TGA, ANVISA, SFDA, MHRA and NMPA.
Shaping RegTech
Active in standardization initiatives, expert training and strategic guidance for the sector.
HOW WE WORK
Expertise first, your data always
Innovation & expertise
Traceability and regulatory know-how combined into a single platform — the core of ACKOMAS.
Customer-centric
Data strategies tailored to each manufacturer's operational and regulatory reality. No two perimeters are the same.
Reliability & security
Robust data protection on Microsoft Azure, global compliance that adapts to local markets.
WHERE WE CONTRIBUTE
At the table where the rules are written
We don't just track regulation — we help shape it. ACKOMAS contributes to the working groups defining how device data moves between manufacturers and regulators.
EcoVadis Committed Badge
Recognizing our commitment to transparency, responsible operations and continuous improvement.
LEADERSHIP
Founders who built traceability before it was RegTech
Christophe Devins
CEO
A pioneer in traceability, Christophe developed the first unitary traceability software in 1989 and co-founded Adents. As CEO, he drives Ackomas’ strategic vision and transformation in data management.
David Carpentier
Technical Director
A graduate of Polytech Nantes, David has deep expertise in traceability systems, having co-founded Adents and now Ackomas. As the technical director, he leads innovation and development.
Nicolas Blanquet
General Manager
READY TO TALK?
Let's see how ACKOMAS can fit and scale with your scope
Tell us about your perimeter through the form. Our team gets back to you within 48h with the right person and the right next step.
