Turning Regulations into Business Opportunities
Every market
is a route.
We know
every line.
Confiquora treats regulatory approval as a strategic asset.
Europe
EU MDR & IVDR
Full CE marking support: classification, technical files, clinical evaluation, notified body liaison.
- EU MDR 2017/745
- IVDR 2017/746
- CE Marking
United States
FDA pathways
Premarket notification strategy, predicate analysis, and submission authoring for 510(k) and PMA.
- FDA 510(k)
- PMA
- 21 CFR Part 11
India
CDSCO licensing
Indian registration and licensing — import, manufacture, and test license support.
- CDSCO
- Import licence
- Manufacturing licence
The route
Six steps to certainty.
Read down the line. The map follows you — from your device to every market it's approved in.
Route planner
Where are you going? We'll draw the route.
Pick what you make and where you want to sell. You get the frameworks on your route, the services that cover them and the document packs that get you started.
1 · What do you make or run?
2 · Where do you want to sell?
Services
Six practice areas. One accountable team.
Pick the area you need. Each one opens a full service brief.
Network
Every sector. Every framework.
Pick a framework to see which sectors it serves — and what we do with it.
Showing all sectors.
A route we ran
The nine-month window.
Document packs
Templates that pass. Help when you need it.
Audit-ready document sets you adapt to your organisation. When you want a hand implementing them, we do that too.
Software
From paper to platform. Same documents, kept alive.
Start with the template packs. When folders stop scaling, run the same documents in Confiquora QMS, with an assistant that drafts and checks for you. People still approve every change.
- 01 · PaperTemplate packs
Documents you adapt, approve and print. Available now.
- 02 · SoftwareConfiquora QMS
Document control with independent approval, revision history, CAPA stages, review reminders and an audit trail nobody can edit.
- 03 · AssistantAI drafting and gap checks
Drafts and revises documents from your instructions and checks the set against ISO 13485. It writes drafts; it never approves.
Ask for early access In development. Subscription pricing will be announced at launch.
More than consultants.
Training
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