CENIT Consulting (US FDA Agent)
CENIT Consulting
U.S. FDA Agent for Medical Devices & IVD. Fast, predictable service with 1 business day FDA notice forwarding. Specialized in foreign establishments only.
CENIT Consulting provides comprehensive regulatory guidance for medical device manufacturers navigating complex global compliance landscapes. With over 15 years of experience, they specialize in accelerating market entry for EU and Asian device manufacturers into the US, acting as a dedicated US FDA Agent. Their services encompass end-to-end pathfinding for EU MDR/IVDR and US FDA regulations, including regulatory strategy, gap analysis, risk management, and submission preparation. CENIT Consulting also offers robust support for Quality Management systems, such as ISO 13485, and information security (ISO 27001), ensuring audit-ready documentation and compliance. For foreign manufacturers, CENIT Consulting's role as a US FDA Agent is crucial for efficient communication with the FDA, import coordination, and avoiding costly delays. They emphasize responsiveness and operational continuity, differentiating their services from distributor-based representation and ensuring smooth import processes. Beyond US FDA representation, CENIT Consulting provides PRRC (Person Responsible for Regulatory Compliance) services for EU MDR/IVDR, offering fast onboarding and ongoing compliance support. Their holistic approach ensures that clients can confidently launch and grow their medical devices in key international markets.
About
**Who they are**
CENIT Consulting (US FDA Agent) provides expert regulatory consulting for medical devices, specializing in US FDA Agent services, EU MDR/IVDR compliance, and Quality Management systems.
**Expertise & scope**
* End-to-end regulatory strategy and execution for medical devices, including SaMD.
* Navigating EU MDR/IVDR and US FDA pathways with submission-ready documentation and realistic timelines.
* Offering external PRRC services with oversight, documentation controls, and Notified Body-ready submissions.
* Developing right-sized ISO 13485 Quality Management systems with templates, training, and audit-ready records.
* Providing US FDA Agent services for foreign medical device and IVD manufacturers, ensuring smooth and timely FDA communications.
* Specializing in regulatory affairs, classification assessment, gap analysis, risk and safety integration, and technical documentation.
**Reputation / proof points**
* Focus on medical devices including SaMD.
* Coverage for US and EU markets.
CENIT Consulting (US FDA Agent) provides expert regulatory consulting for medical devices, specializing in US FDA Agent services, EU MDR/IVDR compliance, and Quality Management systems.
**Expertise & scope**
* End-to-end regulatory strategy and execution for medical devices, including SaMD.
* Navigating EU MDR/IVDR and US FDA pathways with submission-ready documentation and realistic timelines.
* Offering external PRRC services with oversight, documentation controls, and Notified Body-ready submissions.
* Developing right-sized ISO 13485 Quality Management systems with templates, training, and audit-ready records.
* Providing US FDA Agent services for foreign medical device and IVD manufacturers, ensuring smooth and timely FDA communications.
* Specializing in regulatory affairs, classification assessment, gap analysis, risk and safety integration, and technical documentation.
**Reputation / proof points**
* Focus on medical devices including SaMD.
* Coverage for US and EU markets.
Additional information
CENIT Consulting emphasizes a 'submission-first' approach, helping clients define claims, select appropriate regulatory pathways, and build audit-ready documentation for effective communication with regulatory bodies like the FDA and Notified Bodies. They offer clear scope and fast onboarding for their US FDA Agent services, with flexible pricing plans to suit varying compliance needs. Engagement can be tailored based on the level of involvement required, with options to upgrade services as needed. Their services are designed to accelerate EU MDR/IVDR and US FDA pathways by building lean, compliant Quality Management systems.
Key Highlights
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Offers dedicated US FDA Agent services for foreign medical device and IVD manufacturers.
Source
“Appoint CENIT as your U.S. FDA Agent — Today. Select the right plan for your establishment.”
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Specializes in navigating both EU MDR/IVDR and US FDA regulatory pathways for medical devices, including SaMD.
Source
“For medical devices including SaMD — EU MDR/IVDR and FDA pathways delivered with single-point accountability.”
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Provides external PRRC (Person Responsible for Regulatory Compliance) services for EU MDR/IVDR compliance.
Source
“Appoint an EU-Based PRRC (Article 15) — Fast, Audit-Ready Coverage”
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Develops and optimizes ISO 13485-based Quality Management systems integrated with risk management and cybersecurity standards.
Source
“Build a lean, audit-ready QMS that accelerates EU MDR/IVDR and US FDA pathways.”
Certifications & Trust Signals
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Provides practical guidance on EU MDR/IVDR, US FDA QMSR, ISO 13485, and PRRC.
Source
“Get practical guidance on EU MDR/IVDR, US FDA QMSR, ISO 13485, PRRC, and more.”
Buyer Snapshot
Best for
- Foreign medical device and IVD manufacturers requiring a US FDA Agent.
- Companies seeking end-to-end regulatory strategy and execution for EU MDR/IVDR and US FDA pathways.
- Organizations needing to establish or optimize ISO 13485 Quality Management systems.
How engagement typically works
- Project-based consulting.
- Retainer for ongoing support (e.g., US FDA Agent services).
- Flexible engagement levels based on client needs.
Typical deliverables
- US FDA Agent representation.
- Regulatory submission-ready documentation.
- ISO 13485 compliant Quality Management Systems.
- PRRC services.
- Regulatory strategy and pathway guidance.
Good to know
- Best when requiring specialized expertise in medical device regulations for US and EU markets.
- Suitable for companies needing to streamline compliance processes and accelerate market access.
Pricing
Model:
Onboarding + annual retainer
Public range:
Publicly listed: $329 - $1,350
Notes:
Based on publicly listed information for US FDA Agent services; final fees depend on scope and selected plan.
“Pricing: $329; $725; $1,350; pricing,; $329”
HQ:
Houston, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD
Portfolio:
6-25
Flags:
fast_onboarding, ivd
Onboarding time:
2–7 days
Pricing model:
Onboarding + annual retainer
Starting from:
USD 329
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Registration Support:
Yes
Inspection Support:
Yes
Product Type:
devices
Service Types:
US Agent Services, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting, Training/Education
Pricing:
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Response Time:
1 business day for FDA-labeled notices
Switch Time:
~48 hours
Specialization:
Devices & IVD only (foreign establishments)
Additional Services:
core: Official Correspondent (OC),Next-business-day SLA on all tickets,Annual registration/device-listing admin,1 consulting hour/year • plus: GUDID Regulatory Contact,eMDR Account-Owner setup,UDI bundle (≤ 10 DIs),+3 consulting hours
Target Market:
Foreign establishments only (non-U.S. device/IVD manufacturers)
Switch Discount:
15% off year-1 when switching from another agent
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
For US FDA Agent services: Select the right plan, fast onboarding is mentioned. For PRRC services: Assess, Assign, Comply process, onboarding in 3-5 business days.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Medical Devices, IVDs, SaMD
Registration Support
Implied through US FDA Agent services for foreign establishments operating under 21 CFR § 807.
Recall Support
Not explicitly stated, but implied through general FDA communications support.
Inspection Support
Not explicitly stated, but implied through general FDA communications support.
Emergency Contact24x7
Not explicitly stated.
