We help MedTech companies navigate complex regulatory pathways to secure and maintain market access in Europe and the United States.

Our services include MDR and FDA regulatory consulting, ISO 13485 QMS implementation, PRRC services, and acting as Official US FDA Agent.

At CENIT Consulting, we work with global medical device manufacturers, SaMD providers, and innovators — offering efficient, audit-ready strategies that minimize regulatory delays, reduce risks, and accelerate compliance.

Our team is highly specialized in:

-EU MDR 2017/745 Transition & Strategy
-US FDA 510(k), De Novo & Regulatory Submissions
-ISO 13485:2016 QMS Implementation & Alignment with MDR & QMSR 2026
-PRRC
-US FDA Agent Services

We support companies of all sizes, with particular focus on:
-EU market access (MDR, IVDR, PRRC, Notified Body interactions)
-US FDA registrations, submissions, and post-market requirements
-Global regulatory strategy for SMEs and startups entering regulated markets

We are known for our straight-talking, risk-focused, no-nonsense approach to regulatory consulting.

Our clients trust us to help them stay ahead of regulations, avoid costly mistakes, and maintain market access — even in complex, late-stage, or crisis situations.

CENIT Consulting

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