Technicians in cleanroom gowns assembling medical device components on a stainless steel line
    Medical Devices · Diagnostics · Health
    THE ENGINEERING OPERATING SYSTEM FOR REGULATED HARDWARE INDUSTRIES

    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.

    koddex.app · MED-SYS-001
    CardioScan Pro X500 · Ultrasound
    MED-SYS-001
    Locked
    ContentAccessFilesActivity
    StatusBaseline locked · Rev 3.1
    Total mass1,847 gƒ computed
    Requirement coverage94%
    StandardsEU MDR · ISO 13485
    Components2
    ItemAcquisition module (DSP)Locked
    ItemUltrasound probeIn review
    OUR VISION

    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. »

    Stéphane Dicostanzo, Founder & CEO · Koddex
    Stéphane Dicostanzo
    Founder & CEO · Koddex

    « Complex hardware demands a rigorous, regulated methodology. We instill a mindset of flexibility within that rigor, so engineers adapt fast without compromising structure. »

    Thomas Le Blanc, VP of Engineering · Koddex
    Thomas Le Blanc
    VP of Engineering · Koddex
    MEDICAL DEVICES · WHAT WE HEARD, NOT WHAT WE ASSUMED

    Four conversations with medical device teams. Four numbers nobody enjoyed giving us.

    “Show me the room-14 prototype, on the day of the test”

    Fifteen prototypes, none at the same revision level. Three years later the auditor asks which one passed which test. The answer is in a spreadsheet and in the memory of three people, two of whom have left.

    15prototypes

    never at the same revision level

    Requirement
    Verification plan
    « this link exists nowhere »
    Hardware revision
    Audit evidence
    « Proving that the room-14 prototype was at that document level on the day of the test is computerised nowhere. »
    Design Lead · Medical device
    When it gets paid forFDA audit, three years later

    How do you answer that today?

    A test run is a dated fact, attached to one revision.

    A twenty-page checklist, completeness judged by eye

    The impact analysis for a change is done in a meeting, by hand, against a paper checklist. Nobody can say whether it is complete. Nothing reminds anyone of what was skipped.

    20pages

    of paper checklist, ticked by hand

    « We estimate whether the analysis is complete. Finger in the air. »
    R&D Lead · Implants
    When it gets paid forRegulatory submission
    Impact is computed from the graph, not remembered in a meeting.

    Five people out of thirty do the paperwork

    Design control needs the equivalent of five full-time people to document the work of a team of thirty. They are engineers. None of them is designing anything.

    5 / 30engineers

    on documentation, in a typical design team

    « The administrative load of design control took five people for a team of twenty to thirty. »
    Former R&D Director · Medical devices
    When it gets paid forEvery release
    Evidence is a by-product of the work, not a second job.

    Four tools, and the certification impact counted by hand

    Requirements in a spreadsheet, parts in the PLM, CAD in a second tool, the standard as a PDF. Every design change means opening all four and working out by hand what it just invalidated.

    4disconnected tools

    PLM, CAD, the standard as a PDF, and a spreadsheet

    Changed requirement
    « worked out by hand, every time »
    Tests to re-run
    « We need requirements traceability to replace the manual spreadsheets before the launch. »
    Engineering Lead · Medical device
    When it gets paid forEvery design change
    One graph: changing a requirement names the tests it just invalidated.
    REGULATORY LANDSCAPE
    EU MDRISO 13485FDA 21 CFR 820IEC 62304ISO 14971ISO 10993IEC 60601MDSAP510(k)

    The change costs nothing today. It costs everything in three years.

    1. J+0
      The change is committed

      A dimension moves on the device. Two people know. Nothing records why.

    2. J+90
      Design review

      The impact surfaces — on the risk file, on two verification plans nobody reopened.

    3. J+1095
      Notified body audit

      “Prove the configuration on the day of the test.” The proof no longer exists.

    PLATFORM OVERVIEW

    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.

    koddex · visual metamodeling
    SHIP ON TIME. EVERY TIME.

    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.

    1 living BOM0 V1/V2 conflicts÷3 release lead time, observed
    koddex · lock & revisions
    SEE EVERY IMPACT, BEFORE IT HITS.

    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.

    koddex · graph-level computation
    PASS YOUR AUDIT, WITHOUT THE 3-WEEK SPRINT.

    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.

    COMPLIANCE LEVEL · LIVE
    EU MDR · Technical file94%
    IEC 62304 · Embedded software (Class C)81%
    ISO 14971 · Risk management76%
    koddex · traceability

    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.

    YOUR TOOLS. YOUR AGENTS. ONE PRODUCT RECORD.

    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.

    Claude / GPTKoddex MCPProduct graphTargeted permissionsFull audit trail
    Model in daysminutes.
    ENTERPRISE BACKBONE

    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.

    A few of the tools Koddex could plug into
    Siemens logo
    SiemensPLM · MES
    Dassault Systèmes logo
    Dassault SystèmesCAD · PLM
    Autodesk logo
    AutodeskCAD
    SAP logo
    SAPERP
    Rockwell Automation logo
    Rockwell AutomationMES
    Jira logo
    JiraALM
    Confluence logo
    ConfluenceDocs
    GitHub logo
    GitHubCode
    Microsoft Excel logo
    Microsoft ExcelSpreadsheet
    Google Sheets logo
    Google SheetsSpreadsheet
    Anthropic logo
    AnthropicAI agents
    n8n logo
    n8nAutomation
    Siemens logo
    SiemensPLM · MES
    Dassault Systèmes logo
    Dassault SystèmesCAD · PLM
    Autodesk logo
    AutodeskCAD
    SAP logo
    SAPERP
    Rockwell Automation logo
    Rockwell AutomationMES
    Jira logo
    JiraALM
    Confluence logo
    ConfluenceDocs
    GitHub logo
    GitHubCode
    Microsoft Excel logo
    Microsoft ExcelSpreadsheet
    Google Sheets logo
    Google SheetsSpreadsheet
    Anthropic logo
    AnthropicAI agents
    n8n logo
    n8nAutomation

    Koddex is API-first: any tool that exposes an API can read from and write to Koddex. Read this as what the architecture reaches, not as connectors already shipped.

    + 80 integrations · API-first · OAuth or token · bidirectional sync · EU hosting · SOC 2

    IN THEIR WORDS

    Sentence you have already said yourself.

    « Proving that the room-14 prototype was at that document level on the day of the test is computerised nowhere. »
    Design Lead · Medical device
    MedTech
    « We estimate whether the analysis is complete. Finger in the air. »
    R&D Lead · Implants
    MedTech
    « The administrative load of design control took five people for a team of twenty to thirty. »
    Former R&D Director · Medical devices
    MedTech
    « We need requirements traceability to replace the manual spreadsheets before the launch. »
    Engineering Lead · Medical device
    MedTechAerospace & defense
    « We have no technical data management tool at all. Searching and proving compliance are both hard. »
    Technical Director · Medical components
    MedTechIndustry & subcontracting
    « If it is complicated, people do not do it. »
    Design Lead · Medical imaging
    MedTechRoboticsIndustry & subcontracting
    PROOF BY THE NUMBERS

    Finally, an Engineering Operating System for the talents shaping our future.

    +1 000
    licenses deployed, cumulative since 2024
    80
    industrial tools reachable through the open API
    30%
    saved on tools & software licenses, observed on guided deployments
    ÷3
    admin tasks & data collection, observed on guided deployments

    Deployment and saving figures are ranges observed on deployments Koddex runs alongside the team, not an audited average. Scope, team size and regulatory load move each one.

    IMPLEMENTATION

    Operational in days. Audit-ready in months.

    1

    Architecture workshop

    A custom metamodel framed to your product. Objects, attributes, relationships mapped.

    2

    Import & configuration

    BOM, requirements and data migrated. Permissions and roles configured.

    3

    Training & handover

    Role-based sessions for engineering, quality, PM. Autonomous in under a week.

    4

    First workflows in production

    Change control, design freeze, audit trail, live on Koddex. First locked baseline.

    5

    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. »

    Valentin Houssin, Product & Customer Success Lead · Koddex
    Valentin Houssin
    Product & Customer Success Lead · Koddex
    Day 5
    Models created, data structured and collected on Koddex
    Day 14
    Models consolidated and operational. Full autonomy
    Day 90
    Your teams onboarded and trained on Koddex
    Deep support · first 90 daysSupport & CSM guaranteed for 2 years · maintenance within 48h
    FAQ

    Frequently asked questions

    The questions below are the ones engineering, quality and IT teams actually ask us in demos and security reviews. If yours is not here, ask it in a 30-minute call.

    Did we miss your question?

    IN THEIR WORDS

    Verbatims: what hardware teams say about Koddex.