Our Services

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What you will get if you win:

A gap analysis of your QMS and compliance to ISO 13485:2016. Along with a MDR or FDA compliance verification for your Technical Documentation.

Win a free Gap Analysis

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Our services:

We offer a wide range of services within the fields of Regulatoy Affairs (MDR/FDA), Quality Management and PRRC. We also offer Project Management and support you with implementing  your Quality Management System.

Regulatory Strategy

We can offer assistance with your regulatory compliance in several regions throughout the world.

EU & US based PRRC

We can represent your company for this required position in order to maintain compliance to the EU MDR/IVDR.

Quality Management

We can help organizations meet customer, market and regulatory requirements.

US FDA Agent

We can serve as the US agent for medical device manufacturers who do not have a presence in the US.

CENIT Consulting,
Experienced Regulatory Affairs Advisors

Our mission is to guide our clients on their journey to success, with our professional support.

Kami Faust

Partner, COO

Kami is a founding partner and is heading up our EU region focusing on MDR/IVDR as well as our PRRC service.

Dan Stoller

Partner, CRO

Dan is a founding partner and is in charge of our US region focusing on US FDA regulations. 

  • +47 982 96 599 (EU)
  • +1 281 380 6919 (US)
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CENIT Consulting