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Get practical guidance on EU MDR/IVDR, US FDA QMSR, ISO 13485, PRRC, and more. Confidential. NDA available.

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Where we operate

We have a global client base. Hover over any highlighted area to view more about our specific local services.

Service Regions & Clients
Main Offices (Norway & USA)

Frequently asked questions

Short answers designed for MedTech teams and snippet/voice results. For medical devices including SaMD.

Is the initial consultation really free?
Yes—your first consult is complimentary. We use it to confirm scope, timelines, and whether we’re the right fit before any commitment.
How fast can you start?
Most projects kick off within 2–5 business days after discovery and scoping. We’ll propose a start date during your call.
Will you sign an NDA or DPA?
Absolutely. We routinely work under NDA and can provide a DPA on request. Mention this in the contact form.
Do you support both hardware devices and SaMD?
Yes. We support traditional medical devices and SaMD, including device + app + cloud combinations.
Who manages clinical, eQMS, or security partners?
Cenit coordinates vetted partners and integrates their outputs, so you have one accountable plan and point of contact.