MedTech Services Overview

Complete MedTech Regulatory Strategy & Execution

For medical devices including SaMD — EU MDR/IVDR and FDA pathways delivered with single-point accountability. We align partners, documentation, and timelines so you get submission-ready fast.

Prevent launch delays — get a submission-readiness review.
EU MDR/IVDR FDA Submissions ISO 13485 QMS PRRC US FDA Agent
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Medical device submission process: device, regulatory documents, approval stamp

Choose your path

A fast, scannable overview that routes you to the right service page. For medical devices including SaMD.

Regulatory Strategy

Best for new launches or multi-market plans.

End-to-end MDR/IVDR and FDA pathfinding with realistic timelines and submission roadmaps.

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PRRC (EU MDR/IVDR)

Best for EU legal manufacturers.

External PRRC with oversight, documentation controls, and NB-ready submissions.

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Quality Management (ISO 13485)

Best for teams building or upgrading QMS.

Right-sized ISO 13485 systems with templates, training, and audit-ready records.

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Information Security (ISO 27001)

Best for SaMD and data-rich platforms.

ISO 27001 policies, risk, and controls aligned with MDR/FDA expectations.

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US FDA Agent

Best for non-US manufacturers entering the US.

US FDA Agent representation and regulatory pathfinding to accelerate market entry.

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Find my fit

Answer three quick questions to jump to the right service page — for medical devices including SaMD.

Choose one option per question, then press Get recommendation.
Where are you targeting first?
Where are you in the journey?
What’s the biggest gap right now?
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Your best next step

Based on your answers, we recommend the following.

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Ways to engage

Choose the model that best fits your needs. Each path leads to audit-ready outcomes.

Advisory Sprint

Focused advisory to define MDR/IVDR or FDA strategy, surface risks, and produce a clear submission roadmap.

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Project Delivery

Execution to build QMS, prepare submission packs, or coordinate multi-market activities with single-point accountability. Timing tailored to scope.

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Retainer

Ongoing monthly engagement — fractional PRRC, US FDA Agent, or continuous QMS/ISMS maintenance with predictable costs.

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Trusted for compliant, audit-ready outcomes

MedTech regulatory support for medical devices including SaMD — delivered with single-point accountability.

50+ MDR/IVDR launches supported
<5 days Typical project kickoff
5 Vetted specialist partners coordinated
EU MDR / IVDR Classification, documentation, NB readiness
PRRC (EU MDR/IVDR) External accountability & oversight
US FDA Agent, submissions, market entry
ISO 13485 QMS build, maintenance, audits
ISO 27001 Policies, risks, controls for SaMD

Frequently asked questions

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

How fast can you start an MDR/IVDR or FDA engagement?

Most projects kick off within 2–5 days after a discovery call and scope confirmation. If you’re at the planning stage, start with our Advisory Sprint for a precise roadmap.

Regulatory Strategy
Who manages clinical, eQMS, or security partners?

Cenit serves as your single point of accountability and coordinates vetted specialists (e.g., clinical, eQMS, cybersecurity). You get one plan, one owner, and audit-ready outputs.

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Which services are available as a retainer?

PRRC, US FDA Agent, and QMS maintenance are available on ongoing monthly retainers. We tailor cadence and scope to your release risk and audit cycles.

PRRC US FDA Agent QMS
Do you support medical devices including SaMD?

Yes. We support traditional medical devices including SaMD and combination solutions (device + app + cloud). Pathways cover EU MDR/IVDR and FDA.

Regulatory Strategy
What’s included with the PRRC engagement?

Accountable PRRC oversight under MDR/IVDR: documentation controls, conformity checks, partner alignment, and NB-ready submissions — delivered under Cenit leadership.

PRRC Service