of regulatory work is repetitive, manual documentation.
Research & development supported by
The problem
European manufacturers are under structural pressure.
MDR and IVDR have substantially raised the requirements placed on technical documentation. Today's documentation infrastructure was not built for that. The figures below show what follows.
40%
of technical documentation is rejected on first review
Rework, delay, and cost
18mo
average duration of a conformity assessment, roughly twice as long as before MDR
Lost time-to-market
50%
of EU manufacturers no longer prioritise Europe for new assessments
Reduced patient access
33%
of EU manufacturers are actively shrinking their EU portfolio
Supply risk across Europe
Sources: MedTech Europe Facts & Figures 2025 · European Commission Monitoring Report · MedTech Europe MDR/IVDR Leaflet 2025
Our response
The intelligence infrastructure for technical documentation.
The manufacturers who will define European MedTech over the next decade are the ones building on modern infrastructure today — moving faster through approvals, entering new markets with less friction, and operating with the kind of traceability that regulators and partners expect.
Use cases
Solutions built with manufacturers. For manufacturers.
We work directly with manufacturers — bringing real workflows, real documents, and real compliance environments into the development process. You don't just use the infrastructure. You help shape it.
Schedule a conversation
Discover Confideck.
A 30-minute call with our initiators — directly. No sales process. We talk through your regulatory environment, where documentation is slowing you down, and whether Confideck makes sense for your organisation.
