Design, certify and ship your medical devices.
Koddex links requirements, system design, components and certification documentation. Every change stays traceable, every file stays ready for the certification audit.
We build the digital infrastructure for those who design complex physical systems.
The systems behind today's complex hardware products still rely on disconnected files, spreadsheets and siloed tools. For a regulated, safety-critical product, that isn't a tooling problem. It's an infrastructure problem.
Absolute trust by design.
When you read a value in Koddex, you know it's right, structurally guaranteed. Every baseline verifiable, every design decision explainable to an auditor or a regulator.
Structured, yet malleable.
Typed objects, explicit relationships, deterministic workflows. But the business logic is yours. You model your own reality, from the 20-person startup to the global industrial group.
Execution is a craft.
We remove the administrative noise of chasing versions and rebuilding context, so teams can focus entirely on their mission. Software should extend the craft, not get in its way.
« Rigor shouldn't be a brake on innovation. It should be the infrastructure that makes innovation possible. »
« Complex hardware demands a rigorous, regulated methodology. We instill a mindset of flexibility within that rigor, so engineers adapt fast without compromising structure. »
One backbone for a structured, traceable and computable product.
Visual metamodeling
Build your single source of truth. Define your own component blueprints.
Graph-level computation
Automate critical roll-ups. Changes propagate deterministically.
Lock & revision control
Secure your baselines. A locked baseline is a structural guarantee.
End-to-end traceability
Make your lifecycle audit-proof. Requirements linked to physical results.
The same structural challenges, in every medical device.
The gap between PLM and ERP
Design data lives in the PLM, production data in the ERP. The space in between is patched with spreadsheets nobody really trusts.
« There's a gap between our PLM and our ERP, filled with Excel and Word files. Traceability becomes a nightmare. »
Tools that don't talk to each other
Mechanical, electronics and software teams each have their own stack. Syncing them is a manual, error-prone ritual.
« We use different tools for software, mechanical and electronics. Synchronizing them is largely manual. »
The domino effect of change
A single component change cascades across every downstream BOM, forcing drawing rewrites and overloading the engineering office.
« Aligning engineering and production BOMs forces pointless drawing updates, overloading the engineering office. »
Write the BOM you actually ship, then lock it.
Define your engineering objects once. Lock the structure for audit. Revise with full traceability without breaking certification.
Define once, reuse across the whole BOM
A living tree, every discipline edits the same model. No exports, no version confusion.
Lock, branch and revise safely
Freeze a baseline, keep V1 in production, revise V2 on its own branch with zero collisions.
Certification-ready templates
EU MDR, ISO 13485, IEC 62304, ISO 14971. Calibrated by sector from day one.
Visualize the full impact of every change.
A single changed component can affect more than 200 dependencies. Catch every deviation before the commit, not three weeks later.
Items within items
Attributes nested at every level, mirroring a real assembly.
Computation links every attribute
Mass, size and coefficients linked by formulas. A value never lives alone.
Catch the deviation before the commit
An out-of-spec requirement is flagged instantly, the moment a value moves.
Every change already traced. You just click Export.
Audit prep isn't a project. It's a click. The activity history is queryable from program level down to a single attribute.
Activity history at every level
Every action logged with author, timestamp and justification.
Targeted export to auditors & suppliers
Exactly the scope they need. No oversharing, no confidential leak.
Certification-ready evidence
Medical devices, diagnostics, health. Structured for every notified body.
Let AI agents work inside your design record.
Koddex exposes a Model Context Protocol (MCP) so AI agents read, write and automate inside your system models.
Native MCP access
Agents authenticate and receive typed scopes. Every read and write is fully logged.
The same rules as humans
Targeted rights on precise entities. The same approval workflow as your engineers.
Full audit trail
Actor, timestamp, diff, impact, all logged. No agent bypasses a locked baseline.
Koddex becomes the backbone of your organization.
Every role plugs into the same backbone as your PLM, ERP, CRM and tools. One traceable source of truth. No migration, no disruption.
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+ 80 integrations · API-first · OAuth or token · bidirectional sync · EU hosting · SOC 2
One dataset. Every role that moves the program forward.
« I change a dimension on the device and immediately see everything it impacts. No more surprises in review. »
« We unified dozens of Excel files into one single source of truth. Adoption took days, not months. »
« Koddex integrated with our PLM and ERP without breaking anything. Time-to-market was divided by three. »
« I demonstrate a product's compliance live in front of the client, without compiling evidence for weeks. »
« I can prove the exact program configuration at any point in time. Locked baselines killed the drift. »
« My certification audit went from three weeks to ten minutes. Every decision is already traced. »
Finally, an Engineering Operating System for the talents shaping our future.
Operational in days. Audit-ready in months.
Architecture workshop
A custom metamodel framed to your product. Objects, attributes, relationships mapped.
Import & configuration
BOM, requirements and data migrated. Permissions and roles configured.
Training & handover
Role-based sessions for engineering, quality, PM. Autonomous in under a week.
First workflows in production
Change control, design freeze, audit trail, live on Koddex. First locked baseline.
Scale & autonomy
AI integrations, external sharing, impact analysis.
« Onboarding is human and hands-on. We sit alongside your team to build a rigorous, custom infrastructure with limitless flexibility, so you ship the most demanding products. »
Let's take the next step.
Book the demo (30 min)
A demo on medical use cases, ideally with several members of your team. We gather your requirements live.
Book the demo →Verbatims: what hardware teams say about Koddex.