MedTech · Requirements before launch
    CASE STUDY

    A launch date that will not move, and a coverage figure nobody can produce.

    Requirements moved out of spreadsheets into items linked to the components and tests that satisfy them, with coverage computed live — and not one CAD tool was replaced.

    ISO 13485EU MDRIEC 6230421 CFR 820
    KoddexSolvane MedicalProgramme LynxExigences système

    EXG-044 — Débit sanguin régulé à ±5 %

    KDX8Q4Solvane MedicalISO 13485Rev 2Exigence système
    Content Where-used Activity
    reference
    LYNX-EXG-044
    type_exigence*
    Performance
    criticite*
    Critique
    composant_satisfaisant*
    CMP-07 — Pompe péristaltique
    test_de_verification*
    TST-081 — Essai de régulation de débit
    statut*
    Vérifiée
    couverture_enfants
    100 %

    Le débit sanguin doit rester dans une bande de ±5 % de la consigne sur toute la plage de fonctionnement. Vérifié par l'essai TST-081 sur trois unités de série, à trois consignes.

    tests_de_verification3
    Nametype_test*resultat*statut*
    TST-081 — Essai de régulation de débitPerformanceConformeVérifiée
    TST-082 — Dérive sur 6 heuresEnduranceConformeVérifiée
    TST-090 — Reprise après alarmeSécuritéEn coursÀ rejouer

    The customer's workspace, anonymised. Real structure, fields and states.

    0
    CAD tools replaced
    Live
    requirement coverage
    1
    place a requirement lives
    Per user
    audit history, from day one
    Sector Medical devicesStage Pre-launch, 2026Before Manual requirement spreadsheetsConstraint Do not disturb the CAD stack

    Anonymised at the customer's request. The company, the device and every figure are changed. The constraint, the launch pressure and the model are as they were.

    WHAT THEY DESCRIBED

    The requirements exist. Whether they are covered is a matter of opinion.

    WHAT WE BUILT WITH THEM

    A backbone beside the CAD, not instead of it.

    Requirements in spreadsheets

    One file per discipline, updated by hand. A requirement can be satisfied twice, or not at all, and the file will not say.

    A requirement is an item

    Typed, owned, revisable, and linked to the components and tests that answer it. One place, not one file per discipline.

    A launch date that will not move

    Any tool that needs a quarter to be useful is not a candidate. The decision window is measured in weeks.

    Coverage is computed

    The share of requirements with a verified test rolls up the tree. Gaps appear on day one instead of at submission.

    The CAD stack is not negotiable

    The team will not migrate its design tools before a launch. Anything asking them to is refused on the spot.

    CAD stays where it is

    Components reference the CAD artefacts rather than containing them. Nothing in the design stack had to move.

    Technicians in cleanroom gowns assembling medical device components on a stainless steel line
    A launch date, a quality system to satisfy, and a coverage figure nobody could produce.
    THE MODEL

    Five objects, and the only new habit is linking instead of copying.

    KoddexSolvane MedicalProgramme LynxExigences système

    EXG-044 — Débit sanguin régulé à ±5 %

    KDX8Q4Solvane MedicalISO 13485Rev 2Exigence système
    Content Where-used Activity
    reference
    LYNX-EXG-044
    type_exigence*
    Performance
    criticite*
    Critique
    composant_satisfaisant*
    CMP-07 — Pompe péristaltique
    test_de_verification*
    TST-081 — Essai de régulation de débit
    statut*
    Vérifiée
    couverture_enfants
    100 %

    Le débit sanguin doit rester dans une bande de ±5 % de la consigne sur toute la plage de fonctionnement. Vérifié par l'essai TST-081 sur trois unités de série, à trois consignes.

    tests_de_verification3
    Nametype_test*resultat*statut*
    TST-081 — Essai de régulation de débitPerformanceConformeVérifiée
    TST-082 — Dérive sur 6 heuresEnduranceConformeVérifiée
    TST-090 — Reprise après alarmeSécuritéEn coursÀ rejouer
    The customer's workspace, anonymised. Real structure, fields and states.

    What we modelled

    System requirement
    9 attributes
    ƒ
    Component
    8 attributes
    Verification test
    7 attributes
    CAD reference
    4 attributes
    Design history entry
    6 attributes

    Requirement, component, test

    The chain a spreadsheet cannot hold: what satisfies this requirement, and what proves it.

    EXG-044 — Regulated blood flow ±5%
    CMP-07 — Peristaltic pump
    TST-081 — Flow regulation test
    Requirement coverage
    coverage = verified requirements / total requirements

    Coverage, by requirement type

    The figure that used to be an opinion. The right-hand column is computed from the links, not typed.

    Type d'exigenceExigencesTests liésCouverture
    Performance4848100 %
    Fonctionnelle868194 %
    Sécurité3131100 %
    Interopérabilité191263 %

    ƒ Couverture is computed by Koddex, not typed by anyone.

    One requirement, in full

    Débit sanguin régulé à ±5 %

    LYNX-EXG-044
    Exigence système·Imported from the requirement spreadsheet · revision 2
    ContentWhere-used3Activity
    type_exigence
    Performance
    composant_satisfaisant
    CMP-07 — Pompe péristaltique
    test_de_verification
    TST-081
    couverture_enfants
    100 %verified children / total children
    Verification tests
    TST-081Essai de régulation de débit
    TST-082Dérive sur 6 heures
    TST-090Reprise après alarme

    What the graph computes

    Programme · Requirement coverage
    = verified requirements divided by total requirements

    The number the launch review asks for. Previously an estimate; now a value that cannot disagree with the links under it.

    Requirement · Orphan test
    = tests with no requirement pointing at them

    Effort spent proving something nobody asked for. A spreadsheet hides this entirely.

    WHAT CHANGED

    Coverage stopped being something people argued about.

    BeforeAfter
    Where a requirement livesA row in one of several filesAn item, linked both ways
    CoverageAn estimate before each reviewA computed column
    GapsFound at submissionVisible on day one
    The CAD stackA migration nobody would signReferenced, untouched
    Audit historyFile modification datesPer user, per item, per attribute
    WHAT THIS DOES NOT DO

    Three things worth knowing before you defend this internally.

    It is not a CAD tool

    Geometry stays in the design stack. Koddex references the artefact and holds the requirement, the test and the link — which is exactly why it could be adopted before a launch.

    Coverage only counts what is linked

    A requirement with no test attached counts as uncovered, which is the point — but it means the first weeks show a worse figure than the spreadsheet did.

    Importing is not free

    Moving a requirement set out of spreadsheets is quick; deciding what each row actually meant, where two files disagreed, is not.

    Frequently asked questions

    Do we have to replace our CAD tools?

    No, and that was the condition of the engagement. Components reference the CAD artefacts rather than containing them, so the design stack is untouched and the requirement backbone sits beside it.

    Why did coverage get worse at first?

    Because it became real. A computed figure counts only requirements with a verified test attached; the spreadsheet counted rows somebody had marked done. The gap between the two was the point of the exercise.

    Is this fast enough before a launch?

    The model and the first import are a matter of days. What takes longer is settling the requirements the spreadsheets disagreed about — and that work has to happen either way, before or during the submission.