Customer story
An ISO 14971 risk model, built by an agent
- 13
- models created
- 17
- declared links
MedTech
Your design history file, built while you design.
Risk, requirements, design outputs, tests and revisions are linked in one model. Your design history file (DHF) exports when the auditor asks for it, instead of being assembled for weeks beforehand.
1 click
to export the certification file
1 day
for a change impact analysis, instead of 2 weeks of meetings and spreadsheets
Measured at our reference customer after a year in use. Your first scope measures them on your own programme. Reference customer: Exotec, with more than 1,000 users and 20 partner organisations in Koddex.
01
Every design change reopens the file the auditor will read.
Today
Risk spreadsheet
Requirements documents
Test reports
DHF binders
Before every audit, the team assembles the DHF by hand from files that no longer agree.
With Koddex
Risk spreadsheet
Requirements documents
Test reports
DHF binders
User needs, design inputs, outputs and verification are linked in one model, and the DHF exports in one click.
Questions from the field, and how Koddex answers them
ISO 13485, EU MDR and FDA design controls apply to every change.
User needs, design inputs, outputs and verification are linked, so the DHF is a view of your data instead of a separate project.
Risk analysis often lags behind the design.
Hazards, risks and controls live in the same model as the parts and tests.
Software and hardware are certified together.
IEC 62304 software items and hardware parts trace to the same requirements.
Several sites validate the same device.
Every site reads the same released configuration, each in its own scope.
ISO 13485EU MDRISO 14971IEC 62304FDA 21 CFR 820IEC 60601
With Koddex agents
Assign a design change to an agent. It checks which risk controls and verifications the change reopens and moves the review forward in the workflow.
Teams that work with Koddex agents spend up to 50% less time on repetitive engineering tasks.
02
Use cases for MedTech
An agent connected through MCP works on an ISO 14971 risk file
Built with teams in MedTech
Reference scenario
A surgical robot, held as one object
- 5
- engineering domains, one model
- 388.7 kg
- rolled up from the leaves
Customer story
Requirements traceability, three months before launch
- 0
- CAD tools replaced
- Live
- requirement coverage
Customer story
Three systems, the shop floor in none
- 3
- systems, no connectivity
- 1
- graph under all of them
Customer story
One device, validated four ways
- 4
- sites on one device model
- 1
- description of the device
Event
Koddex at SIANE 2026, Toulouse
Booth E15, October 13 to 15. We run live demos on a real engineering project.
A 20-min demo. Your first use case live in 1 month.
Bring one device and one design change. In the demo, we show in Koddex how a design change is traced and how the file exports.