Regulatory Affairs Consulting — CE Marking, US FDA, CDSCO
Every market speaks a different regulatory language. The EU wants MDR conformity and a notified body relationship; the US wants a 510(k) or PMA built on the right predicate strategy; India wants CDSCO licensing with its own classification logic. Getting one wrong costs quarters, not weeks.
Confiquora plans and executes multi-jurisdiction regulatory strategy: device classification, pathway selection, submission authoring, agency and notified body liaison, and the post-market obligations that begin the day approval arrives.
What you get
- Clear pathway & classification strategy
- Submission-ready dossiers
- Faster market access
- Sustained post-market compliance
Standards & frameworks we work in
How an engagement runs
Discovery → Gap Assessment → Strategy → Implementation → Certification → Ongoing Support. Every engagement follows the same spine — scoped in the first call, priced before we start, and handed over with your team trained to run what we build.
Frequently asked questions
Which markets do you cover?
Primarily the EU (MDR/IVDR CE marking), United States (FDA 510(k), De Novo, PMA), and India (CDSCO import, manufacturing, and test licenses) — with MDSAP covering Canada, Brazil, Australia, and Japan through a single audit program.
Can you rescue a submission that was refused or stalled?
Yes. A large share of our regulatory work is remediation — analyzing deficiency letters, rebuilding weak sections, and re-establishing credibility with the reviewer or notified body.
Do you handle CDSCO registration for foreign manufacturers?
Yes — including authorized agent coordination, device classification under the Indian MDR 2017, and the documentation package for import licensing.
Talk it through with us
Free 30-minute consultation. No obligation — just a clear read on where you stand and what it takes.
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