Support is shaped around regulated product teams, not generic management consulting.
About
Regulatory and quality support for MedTech teams crossing EU and U.S. markets.
CENIT Consulting supports medical-device, IVD, SaMD, and quality teams when market access, compliance, and role responsibilities need to be clear before work starts.
Across 25 years of regulatory and quality work, CENIT has supported Class I to Class III medical devices and IVDs through EU and U.S. market entry.
Position
A focused consultancy for regulated MedTech work.
Clients come to CENIT when a regulatory or quality decision needs senior judgment, practical execution, and a clearly defined scope.
Strategy, documentation, QMS, submissions, PRRC, and FDA Agent work are treated as connected decisions.
Clients get a clear responsible contact and practical follow-through, especially when timelines are tight.
Responsibilities, exclusions, timing, and deliverables are clarified before the work becomes operational.
Where CENIT operates
Europe, the U.S., and international market-entry work.
CENIT supports clients working across European, U.S., and selected international regulatory pathways.
Support is aligned to the markets, responsibilities, and coordination lines clients need to manage.
Regulatory and quality work for European market access, coordination, and client support.
FDA-facing work, U.S. FDA Agent support, and North American coordination.
Market-entry, QMS, PRRC, technical documentation, and compliance planning.
Practical market planning and coordination when clients need a broader regulatory view.
How CENIT works
Regulatory work with scope, evidence, and ownership defined.
CENIT starts with the product, market, responsibility, and evidence question, then turns the outcome into documents, reviews, or records the team can use.
CENIT starts by understanding the product type, intended market, current evidence, deadlines, and decision pressure.
CENIT separates its role from what remains with the manufacturer, importer, official correspondent, or other parties.
The work is documented through practical outputs: plans, reviews, role confirmations, QMS materials, or submission-ready content.
Services
Service areas.
Use the relevant service page when the work area is clear, or contact CENIT to define scope first.
Regulatory Affairs EU MDR, IVDR, FDA strategy, market-entry questions. QMS and inspection readiness ISO 13485, QMSR, procedures, audit preparation. PRRC Defined role support under MDR and IVDR. Information Security SaMD, connected-device, ISO 27001, and cybersecurity evidence. U.S. FDA Agent Foreign medical-device and IVD establishments.
Ready
Define the scope before work starts.
Share the product type, market, timing, and main regulatory question. CENIT will confirm the appropriate next step before work begins.