Quality & certification

    The certification file, produced by the work itself.

    Requirements, tests, risks and revisions linked as you go. The audit file exports in one click.

    Claude · koddex MCP · ISO 14971 model
    1 click
    to export the certification file
    1 day
    impact analysis, instead of 2 weeks
    10 s
    to find information, instead of 45 min
    +30 %
    time back on engineering

    Measured at our reference customer after a year in use. Your first scope measures them on your own programme.

    What we heard

    The proof, the checklist, the headcount.

    15
    prototypes

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

    never at the same revision level

    « Proving that the room-14 prototype was at that document level on the day of the test is computerised nowhere. »
    Design Lead · Medical device
    A test run is a dated fact, attached to one revision.
    5 / 30
    engineers

    Five people out of thirty do the paperwork

    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
    Evidence is a by-product of the work, not a second job.
    The gain

    Before and with Koddex.

    Before KoddexWith Koddex
    Produce the certification fileA project before every reviewExported in one click
    Impact analysis of a change2 weeks of meetings and spreadsheets1 day, propagated across the graph
    Structure documents and diagramsSeveral days of retypingMinutes, through an MCP agent
    Find the right information45 min across four tools10 s, where-used in one click
    Engineering productivityTime lost to administration+30 % of time back on the product

    Measured at our reference customer after a year in use. Your first scope measures them on your own programme.

    Built with teams like yours

    Risk files, coverage and validations.

    MedTech · ISO 14971 risk management

    An ISO 14971 risk model, built by an agent

    13
    models created
    17
    declared links
    1
    prompt
    Koddex/Novae Systems/RSK-07 — Placement d'aiguille hors cible

    RSK-07 — Placement d'aiguille hors cible

    WLMC2BNovae SystemsR&DSharedRisque (Epione)
    ContentWhere-usedActivity
    SourcesAllItemChildrenModel
    Sort by Newest
    • QQualitysetstatutto Vérifiée inRSK-07 — Placement d'aiguille hors cible• Today, 11:40 AM
    • RRisk managementchangedmesure_de_maitriseonRSK-07 — Placement d'aiguille hors ciblewhich updatedrisque_residuelinRSK-07 — Placement d'aiguille hors cible• Today, 11:32 AM
    • RRisk managementsetmesure_de_maitrisetoMSR-04 — Butée logicielle de profondeurinRSK-07 — Placement d'aiguille hors cible• Today, 11:31 AM
    • RRisk managementchangedoccurrenceonRSK-07 — Placement d'aiguille hors ciblewhich updatedcriticite_initialeinRSK-07 — Placement d'aiguille hors cible• Today, 10:05 AM
    • RRisk managementsetoccurrenceto 3 inRSK-07 — Placement d'aiguille hors cible• Today, 10:04 AM
    • RRisk managementchangedgraviteonRSK-07 — Placement d'aiguille hors ciblewhich updatedcriticite_initialeinRSK-07 — Placement d'aiguille hors cible• Today, 10:02 AM
    • SSystemsadded 3 items toexigences_couvertesinRSK-07 — Placement d'aiguille hors cible• Yesterday, 4:40 PM
    A control measure set; residual risk recomputes on the risk. Roles shown, no names.
    • Standing up the structure
      Rebuilt by hand per programme
      2 minutes from the brief
    • Severity of a software item
      Traced by hand
      Computed, always current
    • Changing one harm
      Silent inconsistency across tabs
      Propagates to every dependent score
    The core of Koddex

    Model, structure, synchronise.

    koddex · models

    Model

    Your objects and business tasks, modelled by your teams in your vocabulary.

    See the feature
    koddex · lock & revisions

    Structure

    Requirements, BOMs, tests and changes become linked objects, with rights and revisions.

    See the feature
    koddex · computed values

    Synchronise

    Data flows in from your PDM, ERP and MES; computed values propagate on their own.

    See the feature