Your Design Control, structured from day one.
Koddex structures your engineering data into a connected knowledge graph with full traceability, from user needs to verification evidence. Your Design History File stays audit-ready at all times, even when your PLM and ERP don't cover the full picture.
Patterns we see in every MedTech R&D team.
From conversations with engineering leaders in medical imaging, medical devices and gas equipment, the same structural challenges keep coming up.
The gap between PLM and ERP.
"There's a void between our PLM and ERP, filled by Excel and Word files. Traceability and consistency become a nightmare."
Specs, test plans and change requests often end up in disconnected spreadsheets because no single tool covers the full picture. We understand this challenge because we've seen it in every MedTech team we've worked with.
Engineering Director, MedTech Division
Tools that don't talk to each other.
"We use different tools for software, mechanics and electronics. The synchronization between them is largely manual."
SolidWorks, Altium, Sage, Doors... each team has its own stack. The real cost isn't the tools themselves, it's the time engineers spend keeping data in sync instead of designing.
Chief Engineer, Medical Imaging
BOMs that cascade changes.
"Aligning engineering and production BOMs forces unnecessary plan updates, overloading the design office with work that should be spent on R&D."
When engineering and production share the same BOM structure, every production-driven change triggers plan revisions across all levels. Decoupling them gives the design office its time back.
Hardware Manager, Medical Gas Equipment
Built for your regulatory landscape.
A library of certification-ready templates, and humans to deploy them with you.
Koddex ships with reusable models covering the requirements, tests and documentation you need for the most demanding certifications. Migrate your existing data in days, not quarters, and let our team set it up with you.
Certification-ready template library
Pre-built models, requirement trees, risk matrices and test artifacts mapped to industry standards (MDR, DO-178C, ISO 19650…). Start from a baseline that already speaks the language of your auditors.
Accelerated data migration
Import your existing BOMs, requirements and engineering data into a structured graph in days. Stop rebuilding from scratch on every new project.
Expert workshops & integration
Our engineering team runs hands-on workshops and integration sessions with yours, so the platform is operational and adopted from week one.
One backbone for your entire MedTech engineering lifecycle.
Whether you're a 20-person start-up building your first DHF or a 200-engineer R&D team replacing fragmented tooling, Koddex adapts to your process.
Design Control
Build your DHF as a living knowledge graph, not a folder of PDFs. Link user needs, design inputs, design outputs, verification and validation in a single navigable structure.
QMS & Risk Management
Attach risk analyses, FMEAs and safety-critical characteristics directly to your product graph. When a material changes, see every impacted risk control measure instantly.
End-to-End Traceability
Every requirement, test and verification record is linked in a graph. No duplicated data, no broken references. Calculate requirement coverage automatically across your entire product tree.
BOM Management
Manage engineering, methods and production BOMs independently. Stop cascading plan revisions through your entire assembly hierarchy when only production structure changes.
PLM Alternative
No need for a 3-year PLM migration. Start structuring your engineering data today with a flexible knowledge graph that scales from 10 to 200+ engineers.
PEM & Change Management
Track post-market modifications with full impact analysis. Link every change request to affected components, requirements and risk assessments. Export audit-ready PDF and CSV reports.
What MedTech leaders say.
Real feedback from engineering leaders who share the same challenges.
"The tool compiles all our needs and puts everything in one place. It's exactly what we've been missing for structuring our data."
"With this tool, we could decouple engineering and production BOMs and stop wasting the design office's time on plan updates that have nothing to do with actual R&D."
"For scale-ups, this could be the core infrastructure. Not just an efficiency tool, but the backbone. They can't afford to hit the wall on regulatory traceability."
Purpose-built for MedTech engineering.
Three capabilities that transform how your R&D team manages complexity, compliance, and collaboration.
Quality Engineer
Systems Engineer
Methods Engineer
Test Engineer
Config Manager
R&D Lead
Engineering Operating System : Drive complex systems and ship certifications 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.
Enterprise-grade security. Library of certification-friendly templates. Custom deployment for teams of 200+.