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

M. Laurent
Quality Manager
Owner
A. Chen
Systems Engineer
Edit
S. Patel
Electronics Lead
Edit
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 · WAND-EXO · structure tree

System structure

WAND-EXO 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

Selected component

ACT-J3-007

Joint Actuator J3

mass612 g
thermal−10 / 85 °C
revisionREV-2041

Scope-aware

Suppliers and auditors only see the fields you explicitly check — nothing more.

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.

MedTech

ISO 13485 · EU MDR · IEC 62304 · ISO 14971 · IEC 60601

Class IIb infusion pump: dose-rate ratios and risk controls bound to the design history file.

Aerospace & defense

AS9100 · DO-178C · DO-254 · ARP4754A

DAL-B avionics unit: mass and thermal margins traced to every verification.

Nuclear & energy

RCC-M · IEC 61508 (SIL) · 10 CFR 50 App. B · IEC 61513

Safety-class actuator: SIL allocation and qualification coefficients enforced.

Robotics

ISO 10218 · ISO/TS 15066 · EN ISO 13482 · IEC 61508

Cobot cell: speed, force and separation-distance limits computed and guarded.

Advanced manufacturing & automotive

ISO 26262 (ASIL) · IATF 16949

ASIL-D ECU: hazard analysis and safety-goal ratios templated end to end.

Complex infrastructure & rail

EN 50126 / 50128 / 50129 · CENELEC

Signalling subsystem: RAMS budgets and tolerances computed against the norm.

The pain

Audit prep is a three-week archaeology dig

The work was done, but the proof is scattered across tools. Before every audit, engineers stop shipping to reassemble the trail by hand.

No history at the level the auditor asks about

You can show a final document, but not the trail of actions — per collaborator, per item, per attribute — that actually produced it.

Sharing with auditors and suppliers leaks the whole file

There's no clean way to export exactly what a partner, supplier or regulator needs — so you over-share, or rebuild a scoped copy by hand.

Every standard restarts the paperwork

ISO 13485, DO-178C, AS9100, IEC 62304: each authority wants a different cut, and without certification-friendly templates each one is a manual project.

one structured graph

The Koddex way

01 / 04

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.

02 / 04

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.

03 / 04

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.

04 / 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.