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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 and pathway selection, then submission authoring and liaison with agencies and notified bodies, through to the post-market obligations that begin the day approval arrives.

CE Marking US FDA CDSCO

What you get

• Clear pathway & classification strategy
• Submission-ready dossiers
• Faster market access
• Sustained post-market compliance

Standards & frameworks we work in

EU MDR / IVDR FDA 510(k) & PMA CDSCO MDR 2017 MDSAP

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), the United States (FDA 510(k), De Novo and PMA) and India (CDSCO import, manufacturing and test licences). MDSAP then covers Canada, Brazil, Australia and Japan through a single audit programme.

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.