UDI Compliance Software for Medical Device Manufacturers
Manage your device data — for the bases you publish to today, and the ones coming next. EUDAMED, GUDID, Swissdamed, SFDA, AusUDI and beyond, from one workspace.
Trusted by medical device manufacturers — from single-base EU operators to multi-base international groups
Regulatory data is fragmented. Each database asks for different data — in its own format.
Most medical device manufacturers do not have one compliance problem — they have several, one for every regulator they sell to. EUDAMED, GUDID, Swissdamed, SFDA, AusUDI and more. Each one asks for largely different data — country-specific identifiers, registration numbers and classifications, only partly overlapping from one base to the next — each in its own vocabulary, submission flow and inspection pattern. Handling that base by base is where the effort multiplies. One governed source of truth is what makes it manageable.
Multiple databases, same data, wasted effort
The hard work is collecting clean, consistent master data for your devices. Yet most teams rebuild that dataset from scratch every time a new regulator enters their map.
Inspections now check data quality
Since February 2026, the FDA's Compliance Program 7382.850 treats GUDID data quality as an audit criterion. EUDAMED Notified Body audits do the same.
No single source of truth, no audit-readiness
When device data lives in spreadsheets, ERP exports, and parallel platforms, no one can prove what was published, when, and by whom.
From manual re-keying to one governed source
Same data, re-entered in every portal
copied & re-keyed by hand
Govern once, publish to each
validated once, published automatically
All your regulatory databases. One solution.
ACKOMAS supports data synchronization with the active regulatory databases — EUDAMED, GUDID, Swissdamed, SFDA, AusUDI — and onboarding Brazil's SIUD next. The same governed master data feeds every regulator — no parallel datasets, no duplicate effort, no drift over time.
EUDAMED
European Union · European Commission
Live · all classes
GUDID
United States · FDA
FDA Compliance Program 7382.850 enforced Feb 2026
Swissdamed
Switzerland · Swissmedic
Live · MDR/IVDR compliant
SFDA
Saudi Arabia · SFDA
Excel-based · ACKOMAS-managed export
AusUDI
Australia · TGA
Live since 2024 · staggered by class 2026-2028
SIUD
Brazil · ANVISA
In deployment · 2027 expected by class
HOW IT WORKS
How ACKOMAS works
ACKOMAS turns your device master data into a continuous regulatory operation. Four steps, repeated across the lifecycle of every device.
Centralize
Devices, UDI-DIs, Basic UDI-DIs, certificates, attributes — consolidated in one structured, versioned repository with role-based access.
Validate & version
ACKOMAS validates your dataset against each base's rules, flags inconsistencies, keeps full version history. Nothing leaves your workspace.
Publish
Once validated, your data is published through the right channel for each regulator — M2M where supported, supervised flows where required.
Prove & audit
Every change is recorded — what was published, when, and by whom. So when a regulator or notified body asks, the full history is already there, not something you rebuild under pressure.
The ACKOMAS solution in action
A regulatory data governance solution is judged on what regulatory teams actually see when they log in. Here are three of the daily views.
Live regulatory dashboard
Your full regulatory portfolio at a glance — product status, basic UDIs, distribution by regulator, sync history. Spot what's flagged before the regulator does.
Audit trail with version history
Every change logged: who, what, when, before/after. The auditor receives a verifiable record without your team reconstructing anything.
Master catalog, one source
Browse every device across entities and regulators in a single view, with role-based access to who sees and edits what.
What ACKOMAS does
The full functional scope of the solution. Capabilities are organized by domain — not by plan. What you actually access depends on the plan you choose, detailed below.
Regulatory evidence & traceability
Certificates
Publication modes & regulatory operations
Regulatory data management & governance
Security & reliability
Integration & extensibility
Who ACKOMAS is built for
Regulatory affairs & quality teams
You manage device portfolios across multiple markets. The actual work is data: collecting it, keeping it consistent, defending it during audits. ACKOMAS removes the rework — one master dataset validated by the system, ready for every regulator. Submissions become a controlled operation, not a recurring crisis.
Executive teams and decision-makers
You measure compliance by the absence of findings, the speed of audits, and the cost of regulatory drift. ACKOMAS turns those into measurable outcomes: documented audit-readiness, traceable evidence, and infrastructure that scales with your regulatory perimeter. The work compounds. It does not duplicate.
Three plans. Every scale. One source of truth.
ACKOMAS is available in three plans. The difference is not the number of devices you manage — it is how complex your regulatory organization is. All plans run on machine-to-machine (M2M) synchronization and include the full SaaS platform. Pricing is shared after a 30-minute scoping call.
Essential
One regulator, focused catalogProfessional
Several regulators, growing catalogEnterprise
Multiple entities, many regulatorsSCALE & COVERAGE
AUTOMATION & DATA
AUDIT & SUPPORT
Included on every plan
Full SaaS platform · Machine-to-machine sync · Instant compliance checks
Security & reliability
Enterprise-grade security & reliability — included on every plan, by default.
Not sure which plan fits your catalog?
No sales pressure. No demo theater. Just a conversation about your regulatory scope and how ACKOMAS fits.
This page is provided for informational purposes only and is subject to change. Features may be added to Professional and higher versions. Contact us for detailed pricing information.
TRUSTED BY MEDTECH MANUFACTURERS · EUDAMED + GUDID + Swissdamed + SFDA + AusUDI
What our customers say
“Initially, we budgeted for a full-time hire. Today, two of us manage 20,000 UDIs in just a couple of hours per week.”
David Arnould • Regulatory Affairs Manager • Thuasne
“We chose the only solution that addressed both our technical needs and regulatory obligations—Ackomas.”
Etienne GARNIER • Packaging Expert • Laboratoires Théa
“Ackomas’ solution makes regulatory compliance and data security remarkably easy and accessible—even without an IT team.”
Pascal KHALIFÉ • CEO • NovaSpine
FREQUENTLY ASKED QUESTIONS
Questions regulatory teams actually ask
Which regulatory databases do you support today?
EUDAMED (EU), GUDID (US FDA), Swissdamed (CH), SFDA Saudi UDI, AusUDI (TGA). SIUD Brazil and additional jurisdictions are on the roadmap. One workspace, one product catalog, every base.
How is ACKOMAS different from a consulting service or a static template?
We are not consultants — we are software. Our workspace lets your team own the data, run mapping rules, publish to every database, and keep a permanent audit trail. No retainer, no manual rework when a base evolves.
Do you cover Actor Registration, SRN, or Economic Operator workflows?
No. Those are operator-level steps your team handles directly with the competent authority. ACKOMAS focuses on the device, system, and procedure-pack data layer.
What does a typical deployment look like?
Two to six weeks. We onboard your master catalog, configure your mapping to EUDAMED + GUDID, validate a small batch end-to-end, then open the workspace to your full team.
How do you handle our existing data — Excel, ERP, PLM?
We import your existing master catalog, normalize it once, and let you keep ERP/PLM as the upstream system of record. ACKOMAS is the publication layer, not a replacement.
What is the audit trail commitment?
Every change is logged: who, what, when, before/after values. Records are retained for the full ISO 13485 / MDR retention period. Exports available on demand for auditors and notified bodies.
Is ACKOMAS suitable for a manufacturer with three legal entities and one catalog?
Yes — that is exactly what the multi-entity workspace was built for. Share a master catalog across entities, scope user access per entity, publish under the correct manufacturer for each base.
How is pricing structured?
Three plans (Essential, Professional, Enterprise) sized by number of SKUs, users, and bases. We share pricing after a 30-minute scoping call — every catalog is different and a fair quote requires understanding your real shape.
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.
