Product · Impact analyser

    Know what a change breaks before you approve it.

    Change a material, a tolerance or a supplier and the Koddex impact analyser walks your product graph in seconds. Every impacted part, requirement, test and document comes back with its owner and its status.

    Stable, every link green
    System / RootSub-assemblyComponent🫀MED-SYS-001CardioScan Pro X500A. Chen, Systems EngineerACM. Laurent, Quality ManagerMLClass IIbEU MDR 2017v3.1 LOCKEDClass IIb⛔ MDR BREACHREVISION REQ.total mass1 842g1 847g🔊ACQ-MOD-002Ultrasound Acq. ModuleA. Chen, Systems EngineerACS. Patel, Electronics LeadSPK. Olsen, Materials Spec.KO2–18 MHz · 256chVALIDATED2–18 MHz · 256ch⚠ IMPACTEDmass612g617g🖥️DSP-MOD-003Image Processing UnitL. Garcia, Software Arch.LGS. Patel, Electronics LeadSPARM A72 · 16GBVALIDATEDmass380g🔋PWR-MOD-004Power Management UnitS. Patel, Electronics LeadSP12V/5V · 4.5hVALIDATEDmass280g🔬PZT-001Piezo Array PZT-5HK. Olsen, Materials Spec.KO128 elementsOKmass42g🎛️MUX-002Analog MUX 256chS. Patel, Electronics LeadSP256 channelsOKmass38g🩻ACL-003Acoustic Lens CoverK. Olsen, Materials Spec.KOM. Laurent, Quality ManagerMLPU medical · ISO 10993OK⛔ MDR BREACHISO 10993-1mass0.65g0.70g🔌CON-004SMA RF ConnectorR. Tanaka, RF EngineerRTSMA 50ΩOKmass12g🧲SHLD-005EMC Shield LayerJ. Dupont, Mechanical Eng.JDS. Patel, Electronics LeadSP60 dB atten.OKmass95g💧SEAL-006IP67 Seal AssemblyJ. Dupont, Mechanical Eng.JDIP67/IP68OKratingIP67

    A dependency you never declared is a dependency nobody can check.

    In spreadsheets and PDFs, a change to one component quietly invalidates requirements three levels up. Nobody notices until certification, when remediation costs the most. Koddex holds those links as typed edges, so the consequences of a change are visible at the moment it is proposed.

    Propagation

    See the blast radius in one click.

    Every component, requirement, test and document is a typed node in a deterministic graph. Touch one and Koddex traverses the edges for you, upstream to the systems that depend on it, downstream to the evidence that backs it.

    • Recursive roll-up formulas aggregate compliance status across the whole tree
    • Stale test evidence is flagged automatically instead of rediscovered by hand
    • Variant aware, so you see which configurations the change actually touches
    How the computed engine works
    koddex · Impact analyser
    Ultrasound Probe X200System
    Housing & Cable AssemblyComponent
    Biocompatible Resin BR-12Material
    REQ · Biocompatibility ISO 10993Requirement
    TEST · Cytotoxicity report v4Evidence
    Transducer Array TA-64Component
    REQ · EMC IEC 60601-1-2Requirement
    Decision

    Turn the traversal into a change request people can approve.

    An impact list nobody owns is just a longer to-do list. Koddex turns the traversal into a reviewable change request: what moved, what it broke, who has to re-verify it, and what still blocks approval.

    • Field-level before and after diff on every impacted item
    • Owners notified the moment a requirement they hold is affected
    • Approval gates that refuse to close while a requirement is unverified
    Design reviews and collaboration
    koddex · CR-2841In review
    FieldBeforeAfter
    MaterialResin BR-12Resin BR-18
    Durometer72 Shore A68 Shore A
    SupplierPolyMed SAElastane Ltd
    2 requirements need re-verification before this CR can be approved.
    QualitySystemsRegulatory
    Evidence

    Ship the audit trail with the change.

    The reason a change was safe has to survive the two years before the auditor asks. Every traversal, re-verification and sign-off is recorded against a frozen baseline you can export as a dossier.

    • Immutable baselines with content hashes, so nothing is edited after the freeze
    • Traceability from a certification clause down to the component that satisfies it
    • Export the whole chain without rebuilding it from email threads
    Design freeze and revisions
    koddex · Baseline freeze
    Revision frozen with its evidence

    What changes when dependencies are explicit.

    Koddex does not promise your change gets approved faster. It promises you know what it costs before you commit to it.

    Every link is traversable

    Component, requirement, test and document sit in one graph, so no dependency lives only in someone's head.

    100%
    Traceability coverage

    Unverified requirements surface immediately

    The graph re-evaluates on write, so a broken requirement shows up when the change is proposed, not at the review.

    Instant
    Visibility on unverified requirements

    No hidden compliance blind spots

    Every edge is explicit and auditable, from a raw material through to the certification clause it supports.

    0
    Hidden compliance blind spots

    Frequently asked questions

    Bring us a change you shipped last quarter.

    We model it in Koddex during the call and traverse it live, so you see the impact analyser on your product rather than on a demo dataset.