CENIT Consulting
FDA U.S. Agent for Medical Devices and Cosmetics only. Not for Food & Beverage or Food Facility Registration. Strategic compliance partner for MedTech and digital health.
CENIT Consulting serves as FDA U.S. Agent for foreign establishments in two sectors only: Medical Devices (including IVDs) and Cosmetics.
**Scope (per provider):**
- Medical devices and IVDs: U.S. Agent for foreign device manufacturers per 21 CFR Part 807
- Cosmetics: U.S. Agent for foreign cosmetic facilities under MoCRA
**Excluded:** Food & Beverage. CENIT does not provide Food Facility Registration or U.S. Agent services for food.
With offices in the EU and USA, CENIT offers regulatory and quality strategy for MedTech and digital health. Services include FDA registration and renewal, UDI/GUDID compliance, and Master File submission support for medical devices.
About
**Who they are**
CENIT Consulting is a strategic compliance partner specializing in regulatory pathways for medical devices and digital health companies. They focus on providing FDA U.S. Agent services and comprehensive regulatory strategy and execution.
**Expertise & scope**
* FDA U.S. Agent for Medical Devices and IVDs, partnering with foreign establishments operating under 21 CFR § 807.
* End-to-end regulatory strategy and execution for EU MDR/IVDR and FDA pathways, including submission-ready documentation.
* Quality Management System (QMS) establishment and optimization based on ISO 13485, with integration of ISO 14971 risk management, IEC 62304 software, and cybersecurity.
* PRRC (Person Responsible for Regulatory Compliance) services for EU MDR/IVDR, including assessment, appointment, and ongoing compliance support.
* Regulatory Affairs support covering classification assessment, gap analysis, risk & safety, DHF & Technical Documentation, and submissions.
**Reputation / proof points**
* Focus on Medical Devices including SaMD.
* Offers services for both EU and US markets.
* Emphasis on audit-ready documentation and smooth agency communications.
CENIT Consulting is a strategic compliance partner specializing in regulatory pathways for medical devices and digital health companies. They focus on providing FDA U.S. Agent services and comprehensive regulatory strategy and execution.
**Expertise & scope**
* FDA U.S. Agent for Medical Devices and IVDs, partnering with foreign establishments operating under 21 CFR § 807.
* End-to-end regulatory strategy and execution for EU MDR/IVDR and FDA pathways, including submission-ready documentation.
* Quality Management System (QMS) establishment and optimization based on ISO 13485, with integration of ISO 14971 risk management, IEC 62304 software, and cybersecurity.
* PRRC (Person Responsible for Regulatory Compliance) services for EU MDR/IVDR, including assessment, appointment, and ongoing compliance support.
* Regulatory Affairs support covering classification assessment, gap analysis, risk & safety, DHF & Technical Documentation, and submissions.
**Reputation / proof points**
* Focus on Medical Devices including SaMD.
* Offers services for both EU and US markets.
* Emphasis on audit-ready documentation and smooth agency communications.
Additional information
CENIT Consulting offers a clear scope and fast onboarding for their U.S. FDA Agent services, partnering with foreign medical device and IVD manufacturers. They provide flexible engagement models, allowing clients to select the level of involvement needed and upgrade services as required. Their approach emphasizes streamlining FDA communications and ensuring timely responses for foreign establishments. For PRRC services, they offer a quick readiness check and formal appointment process, aiming for operational continuity and audit-ready records.
Key Highlights
-
Specializes in FDA U.S. Agent services for Medical Devices and IVDs.
Source
“We partner with medical device and IVD manufacturers (foreign establishments) operating under 21 CFR § 807.”
-
Provides end-to-end regulatory strategy for EU MDR/IVDR and FDA pathways.
Source
“End-to-end MDR/IVDR and FDA pathfinding with realistic timelines and submission roadmaps.”
-
Offers ISO 13485-based Quality Management Systems for medical devices.
Source
“Build a lean, audit-ready QMS that accelerates EU MDR/IVDR and US FDA pathways.”
-
Provides EU PRRC services with fast onboarding (3-5 business days).
Source
“Onboard in 3–5 business days. SaMD & hardware, Class I–IIb.”
Certifications & Trust Signals
-
Experienced team focused on medical devices and IVDs.
Source
“Clear scope, fast onboarding, and an experienced team focused on medical devices and IVDs.”
Buyer Snapshot
Best for
- Foreign medical device and IVD manufacturers requiring a U.S. FDA Agent.
- Companies seeking end-to-end regulatory strategy for EU MDR/IVDR and FDA pathways.
- MedTech and digital health firms needing ISO 13485-based Quality Management Systems.
How engagement typically works
- Strategic partnership for compliance.
- Flexible service bundles based on client needs.
- Focus on submission-ready documentation and agency communication.
Typical deliverables
- Appointed U.S. FDA Agent.
- Regulatory submission roadmaps.
- ISO 13485-aligned QMS documentation.
- PRRC appointment and ongoing support.
Good to know
- Best when focused on Medical Devices and IVDs.
- Not for Food & Beverage or Food Facility Registration.
Pricing
Model:
Onboarding + annual retainer
Public range:
Publicly listed: $329, $725, $1,350
Notes:
Pricing varies based on selected plan and scope of services.
“$329; $725; $1,350; pricing,; $329”
HQ:
Houston, United States
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD, Cosmetics
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:
lite: [object Object] • core: [object Object] • plus: [object Object]
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
Scope:
Medical devices, IVD, and Cosmetics only. Not for Food & Beverage or Food Facility Registration.
Target Sectors:
Medical devices, IVD, Cosmetics
Excluded Sectors:
Food, Beverage, Food Facility Registration
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 U.S. FDA Agent services: Select the right plan, fast onboarding. For PRRC services: Assess, Assign, Comply; onboard 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 U.S. FDA Agent services for foreign establishments.
Recall Support
Not explicitly mentioned.
Inspection Support
Not explicitly mentioned.
Emergency Contact24x7
Not explicitly mentioned.
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare CENIT Consulting and other vetted providers — instant pricing, no RFQ needed.
