← Use Cases

    The work was done. Three years later, the proof is not.

    Every change already traced: when the auditor arrives, you just click Export.

    WHAT THE AUDITOR ASKS FOR

    What the auditor asks for, and where the answer is not.

    “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.

    The question about one line of the standard, still open

    Everybody is comfortable with the standard in outline and nobody knows it to the letter. So how one clause should be read gets asked, gets escalated, and three months later has still never been settled — while design carries on around it.

    3months

    one clause, escalated, never settled

    « Nobody knows the standard to the letter. You end up on some tiny detail that was never settled. »
    Business Unit Director · Defence programmes
    When it gets paid forAuthority filing
    The reading you chose is recorded on the requirement, with its date and its author.

    The standard everyone is sure about is the 2015 one

    Standards get revised a handful of times in a career, so people stay confident in the version they learned. Then two thousand units have to be built to it, by technicians nobody trained on the current text.

    2 000units to build

    to a standard that ages in people's heads

    « He was completely sure of himself — on a version of the standard that was true fifteen years ago. »
    Business Unit Director · Nuclear instrumentation
    When it gets paid forTraining the production technicians
    The standard is a dated version in the model, not a memory.

    One document. Granular permissions. A complete audit trail for every share.

    Every internal collaborator gets a role-based view. When the technical file leaves the company for a notified body, only the sections you explicitly check are shared. The rest stays sealed.

    Document at rest, owner only
    koddex.app · governance · technical file EXG-MEDB-022

    Inside Koddex · internal team

    org access

    Technical file · v3.1 LOCKED

    EXG-MEDB-022 · Medical Biosensor

    • Component identity
    • Operating spec
    • Compliance status
    • Verification reports
    • Material composition
    • Supplier & cost data
    • Internal R&D notes

    Collaborators · role-based access

    • ML

      M. Laurent

      Quality Manager

      Owner
    • AC

      A. Chen

      Systems Engineer

      Edit
    • SP

      S. Patel

      Electronics Lead

      Edit
    • PM

      P. Moreau

      Project Manager

      Review

    Outside Koddex · external auditor

    scoped view

    No external recipient yet.

    Pick the sections you want to share. Confidential data stays inside Koddex.

    Share part of a component. Keep the rest confidential.

    Pick a component, tick the attributes you want suppliers and auditors to see, leave the confidential ones unchecked. Every recipient gets a scoped, revocable view, and every access is logged.

    koddex.app · EXO-LL · structure tree

    System structure

    • EXO-LL Lower Limb (System)v3.1 LOCKED
    • Joint Assembly J3VALIDATED
    • ACT-J3-007, Joint Actuator612g
    • ENC-J3-002, Magnetic EncoderOK
    • TH-J3-005, Thermal PadOK
    • Carbon Frame AssemblyVALIDATED
    • MNT-A1, Carbon Mount PlateOK

    Certification-friendly templates for complex systems

    Start from templates tuned to the standards each market demands, so structure, formulas, limits and evidence are wired to the certification from day one.

    See the templates for each sector

    The Koddex way

    Every action already traced, at every level. When the auditor arrives, you click Export.

    1. 01

      Activity history at every level

      Every action is logged with author, timestamp and rationale, queryable from the whole program down to a single attribute on a single component.

    2. 02

      Detail per collaborator

      See exactly what each engineer, reviewer or AI agent changed and approved, the trail the auditor actually asks for, not just a final PDF.

    3. 03

      Scoped export to partners, suppliers, auditors

      Generate exactly the slice each external party needs, live, without copying files out of your perimeter or over-sharing confidential data.

    4. 04

      Certification-friendly templates per sector

      Start from templates tuned to the standards Koddex's industries face (MedTech, aerospace, nuclear, robotics) so the evidence is structured the way each auditor expects.

    Performance Impact

    100%
    Requirement Coverage
    ÷50
    Audit Prep Time
    0
    Coverage Gaps at Submission
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    Koddex

    Drive complex systems without frictions.

    Stop bleeding hours on version chasing, audit prep and cross-team sync. Ship certified hardware faster, on a foundation built for the next decade of complexity.

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