Meet CENIT Consulting — Pathway to MedTech compliance

We deliver audit-ready submissions, lean ISO 13485 QMS, PRRC, US FDA Agent, and ISO 27001 for SaMD — with single-point accountability from scoping to approval.

PRRC Device Classification Global clients (EU/US/APAC) US FDA Agent

Trusted by medical device and SaMD innovators across EU, US, and APAC—from first submission to global scale.

EU MDR / IVDR US FDA ISO 13485 ISO 27001 EU · US · APAC

Why teams choose CENIT

Submission-first mindset
We work backwards from approval—classification, evidence, and documents aligned to EU/US expectations from day one.
Single accountable plan
One owner, one plan. We coordinate vetted partners and integrate their outputs—no vendor ping-pong.
Lean, scalable QMS
Right-sized ISO 13485 with templates, training, and audits—built to scale with your product and team.
Blended device + software expertise
Hardware, SaMD, or combined—risk, clinical, and security streams align to the product you’re actually shipping.
Predictable delivery
Clear milestones, regular reviews, and KPIs—so your board knows when submissions land and audits pass.
Global coverage
Projects across EU/US/APAC with regional partner oversight—one coordination layer, multiple markets.

How we deliver

1
Scope & pathway
EU/US route, classification, partner needs, timelines.
2
Build the pack
Evidence & documents aligned to NB/FDA expectations.
3
QMS that fits
Lean ISO 13485 with training & audits—scaled to your org.
4
Security for SaMD
ISO 27001 policies, risks, controls—platform-ready.
5
Approve & sustain
PRRC / FDA Agent oversight and ongoing maintenance.
Need an audit-ready path for EU/US—or a QMS that won’t slow you down?