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Bridging Compliance and Commercial Success for USA MedTech
Your Partner in USA MedTech Regulatory Success
MedReg Consultancy helps medical device manufacturers navigate the US regulatory landscape with ease. From ISO 13485:2016 and CE certification to USFDA listings, 510(k), PMA, and UL approvals, we deliver tailored end-to-end solutions. With expertise in submissions, QMS, compliance, and post-market support, we simplify every stage, ensuring your products remain compliant and competitive in the US MedTech market.
Services We Offer in The USA
As a trusted partner in medical device regulations, MedReg Consultancy offers comprehensive services across the US market.
Establishment and Listing
Establishing and listing your medical device company is essential for compliance and market access in the US. At MedReg Consultancy, we streamline the entire process, from FDA establishment registration and device listing to documentation and submission management, helping you achieve full regulatory compliance efficiently and confidently.
GUDID Submission
Submitting your device information to the FDA’s GUDID database is essential for US market compliance. At MedReg Consultancy, we manage the entire GUDID submission process, from data preparation to validation and reporting, helping you ensure accurate registration and seamless regulatory adherence with confidence.
QMS Implementation- QMSR
Implementing a robust Quality Management System (QMS) is critical for USFDA compliance. At MedReg Consultancy, we guide medical device companies through QMS implementation and QMSR processes, from documentation and training to audits, helping you achieve regulatory readiness and maintain ongoing compliance with confidence.
Premarket Submission-510K
Submitting a 510(k) premarket notification is essential for medical device companies seeking US market entry. At MedReg Consultancy, we streamline the entire 510(k) submission process, from preparing required documentation and risk assessments to interacting with the FDA, helping you achieve timely regulatory clearance with confidence.
Q-Submission
A Q-Submission is a vital tool for engaging with the FDA and clarifying regulatory requirements before submitting your medical device. At MedReg Consultancy, we manage the entire Q-Submission process, from preparing briefing documents to coordinating interactive discussions, helping you obtain clear guidance and ensure a smooth path to compliance with confidence.
Small Business Documentation
Proper documentation is crucial for small medical device businesses to ensure FDA compliance and smooth market entry. At MedReg Consultancy, we assist in preparing and organizing all required regulatory documents, guiding you through submissions and maintaining compliance efficiently and confidently.
Interactive Discussion with FDA after Submission
Engaging in an interactive discussion with the FDA after submission is essential for clarifying regulatory requirements and addressing questions. At MedReg Consultancy, we guide medical device companies through the entire process, from preparing discussion materials to coordinating meetings, helping you obtain clear feedback and ensuring a smooth path to compliance with confidence.
Responding to Additional Information
Responding to FDA requests for Additional Information is critical to keep your medical device submission on track. At MedReg Consultancy, we manage the entire process, from analyzing the request and preparing accurate responses to submitting them promptly, ensuring your regulatory review progresses smoothly and confidently.
US Agent Service
Having a designated US Agent is essential for medical device companies to meet FDA requirements and maintain regulatory compliance. At MedReg Consultancy, we provide reliable US Agent services, managing communication with the FDA, handling submissions, and ensuring your company stays fully compliant with confidence.
483 Response and submission
Responding to FDA Form 483 observations is critical for maintaining compliance and avoiding regulatory delays. At MedReg Consultancy, we guide medical device companies through the entire process, from analyzing inspection findings to preparing and submitting detailed responses, ensuring timely resolution and regulatory confidence.
Complaint File Submission
Proper complaint file submission is essential for maintaining USFDA compliance and ensuring patient safety. At MedReg Consultancy, we help medical device companies manage the entire process, from documenting complaints to submitting reports, ensuring regulatory adherence and efficient handling of product issues with confidence.
E-Copy Guidance
Submitting an accurate electronic copy (E-Copy) is essential for FDA compliance and smooth regulatory review. At MedReg Consultancy, we guide medical device companies through preparing, formatting, and submitting E-Copies, ensuring your documentation meets FDA requirements efficiently and with confidence.
GMP compliance for USFDA inspection.
Ensuring GMP compliance is critical for a successful USFDA inspection. At MedReg Consultancy, we help medical device companies prepare for inspections by reviewing processes, implementing best practices, and guiding documentation, ensuring your facility meets FDA standards efficiently and confidently.
Certification Success, Without the Stress
Why Choose Medreg
Expert consultants, thorough regulatory insight, and a seamless path to compliance, that’s our promise for your medical devices.
Focused on Your Goals
Your challenges guide our approach. By actively listening, we design focused strategies that deliver measurable, result-driven outcomes.
Simplifying Complexity
We decode Complex regulatory requirements and define a clear, actionable pathway, to ensure your projects move forward efficiently and compliantly.
Comprehensive Understanding
We dive deep into your requirements, identifying all critical factors to ensure our solutions address every aspect of your regulatory needs.
Documentation You Can Trust
As experts, we provide clear, accurate, and accessible documentation, keeping you informed at every stage of your project.
Number speaks everything
Our numbers tell a story of growth, trust, and proven success. Every result reflects our expertise, commitment, and measurable impact.
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Get the Answers You Need to Move Forward
Navigating medical device regulations doesn’t have to be overwhelming. At MedReg Consultancy, we’ve answered the most common client questions to quickly guide you through our services and how we can support your compliance journey. From emerging startups to established global players, our FAQs are your first stop. Need personalised help? We’re just a message away!
We provide end-to-end solutions for US market entry, including USFDA listings, 510(k) submissions, PMA approvals, QMS implementation, GUDID submissions, CE certification, technical master file preparation, clinical evaluations, and post-market surveillance. Our goal is to ensure your devices meet all US regulatory requirements efficiently and confidently.
Our team streamlines the entire premarket submission process, from preparing documentation and risk assessments to interacting with the FDA, ensuring timely regulatory clearance and smooth market access for your medical devices.
We help companies prepare for GMP compliance audits, respond to Form 483 observations, manage complaint file submissions, and guide documentation practices, ensuring your facility meets FDA standards and maintains ongoing compliance.
As a designated US Agent, we manage communication with the FDA, handle submissions, and support ongoing compliance. We also guide medical device companies through GUDID submissions, ensuring accurate registration and adherence to FDA requirements.
Yes! We provide small business documentation support, Q-Submissions, interactive FDA discussions, and responses to Additional Information requests, helping emerging medical device companies navigate US regulatory processes efficiently and confidently.