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A Joint Initiative
For A Future-Proof Industry.

Confideck team
Confideck experts
Discussion
Confideck Congress presentation

EU Industry Initiative

Strengthening the innovation capacity of European manufacturers.

Get involved
50%
of regulatory work is repetitive, manual documentation.
Research & development supported by

The problem

European manufacturers
are under structural pressure.

To stay at the forefront, manufacturers need to move fast. The current regulatory documentation infrastructure makes that structurally impossible — and the numbers show what happens when it doesn't change.

01 — Approval failure
40%
of initial EU approval applications fail on the first attempt
Not because of product quality — because of documentation gaps, inconsistent cross-references, and missing traceability.
Rework, delay, and cost
02 — Time to market
18mo
average time for an EU approval — twice as long as before MDR
Teams are using the same processes and tools against requirements that have fundamentally doubled in scope and complexity.
Lost time-to-market
03 — Market withdrawal
50%
of EU manufacturers deprioritise Europe for new approvals
The documentation burden is reshaping where products are launched first — and Europe is losing ground to other markets.
Reduced patient access
04 — Portfolio reduction
33%
of EU manufacturers are actively shrinking their EU portfolio
Devices that were available to patients are being withdrawn — not because of safety concerns, but because of documentation cost.
Supply risk across Europe

Sources: MedTech Europe Facts & Figures 2025 · European Commission Monitoring Report · MedTech Europe MDR/IVDR Leaflet 2025

Our approach

Built with the right people.
Engineered to keep advancing.

Co-developed with

Manufacturers & RA teams

Every module was shaped by the people who use it daily — regulatory affairs managers, documentation specialists, and quality teams across European MedTech companies.

Validated by

Notified body auditors

Every workflow and output was reviewed against real audit criteria. What Confideck generates is not just compliant in theory — it is structured the way auditors expect to see it.

Built on

Advanced software engineering

Deep roots in enterprise software architecture, graph-based data models, and validated AI. The infrastructure is built to scale — across products, markets, and regulatory frameworks.

01
Goal one — Today

Make technical documentation a solved problem.

Every manufacturer working with Confideck today gets a validated, audit-ready environment for creating, maintaining, and registering technical documentation — across products, markets, and teams. User-friendly enough for daily use. Rigorous enough for regulatory scrutiny.

02
Goal two — Always advancing

Keep solving what manufacturers face next.

Regulations change. Markets expand. Products evolve. Confideck is built to advance alongside them — with new modules, new jurisdictions, and new intelligence added continuously. Every update is shaped by what manufacturers tell us they still need. We are not done.