FDA · ISO 13485 · UDI · CE Mark

Regulatory Expertise
That Moves Devices
To Market.

Mansour Consulting delivers precise, practical regulatory solutions for medical device manufacturers — from 510(k) strategy and quality systems to global UDI compliance and integrated software.

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30+
Years of Experience
7
Practice Areas
US & EU
Market Coverage
Jay Mansour, MSQA BE RAC — Principal, Mansour Consulting LLC
Jay Mansour MSQA, BE, RAC Principal  ·  US Agent  ·  Official Correspondent
FDA · CE Mark · GUDID · EUDAMED · Health Canada

About Us

Decades of FDA Experience. Delivered Directly.

Mansour Consulting LLC is a specialized regulatory consulting firm serving the medical device industry since 2000. With over 30 years of industry experience, principal Jay Mansour brings senior-level expertise across the full product lifecycle — from initial regulatory strategy through postmarket obligations.

Based in Roswell, Georgia, we serve US and international clients, traveling wherever the work demands. Our approach is direct, efficient, and built around your timeline and budget.

We also develop and market an integrated compliance software platform combining ERP, Document Management, LMS, labeling, and UDI tools — purpose-built for small medical device manufacturers.

FDA 510(k) ISO 13485 21 CFR Part 820 GUDID / EUDAMED CE Mark PCCP / AI-ML Health Canada UDI Compliance

What We Do

Our Practice Areas

🔬
Technical Assistance

Strategic support coordinating R&D activities, laboratory testing, and patent applications with external parties — keeping your development on track.

R&D Lab Testing Patent Support
📋
Regulatory Assistance

End-to-end regulatory strategy including 510(k) submissions, FDA 483 and Warning Letter responses, software validation, and strategic planning for market access.

510(k) FDA 483 Validation
⚖️
Medical Device Evaluation

Flat-fee regulatory pathway assessment for your device — classification, submission type, and roadmap. Know exactly what you need before you spend.

Classification Pathway Analysis Fixed Fee
🏗️
Quality Systems

Design and implementation of FDA-compliant quality systems under 21 CFR Part 820 and ISO 13485, including CE Mark technical files and internal audits.

21 CFR 820 ISO 13485 CE Mark
🏷️
UDI Compliance

Complete Unique Device Identification compliance — GUDID setup, data management, EUDAMED registration, and ongoing maintenance for US and EU requirements.

GUDID EUDAMED Data Management
🏛️
FDA Representation

US Agent and Official Correspondent services for foreign manufacturers — registration, listing, import/export guidance, CFG, and FDA inspection support.

US Agent Import/Export Inspections
💻
Integrated Software Solution

A purpose-built compliance platform combining ERP, Document Management (DMS), Learning Management (LMS), and label management — tailored for small device manufacturers.

ERP DMS LMS Labeling

Why Mansour Consulting

Senior Expertise. Practical Results.

01
Direct Senior Engagement You work with the principal — not junior associates. Every project benefits from over 30 years of medical device industry experience.
02
Full Lifecycle Coverage From pre-submission strategy through postmarket surveillance, we cover every stage a device must navigate.
03
US & Global Reach FDA, EU MDR/IVDR, Health Canada, and beyond — with field experience in both domestic and international regulatory environments.
04
Transparent, Efficient Pricing Focused engagements, clear scope, and flat-fee options for defined work — so your budget goes toward results, not overhead.

Practice at a Glance

30+
Years of Experience
US & EU
Regulatory Reach
510(k)
510(k) Submissions
7
Service Areas

Roswell, Georgia based — serving clients across the United States and internationally. Available for on-site engagements worldwide.

Company Brochure

Your Trusted Partner for Medical Device
Quality & Regulatory Compliance

Download our two-page brochure for a concise overview of our services — covering FDA representation, UDI compliance, 510(k) submissions, quality systems, and more. Ideal for sharing with colleagues or prospective partners.

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Get in Touch

Let's Discuss Your Project

Whether you're navigating your first 510(k), responding to an FDA 483, or building a quality system from the ground up — we're ready to help. Reach out for a confidential, no-obligation conversation.

✉️
📞
+1 (678) 908-8180
📍
Roswell, Georgia, USA

Send a Message

All inquiries are confidential. We typically respond within one business day.