MedEnvoy Global
MedEnvoy Global is a leading regulatory consulting firm specializing in medical device market entry and compliance in the US and globally. They offer expert guidance for FDA submissions, registration, and QMS.
MedEnvoy Global is your premier partner for navigating the complexities of medical device and IVD global market entry. Specializing in US FDA compliance, they offer comprehensive services including US FDA Agent representation, FDA Establishment and Medical Device Registration Support, FDA 510(k) clearance consulting, FDA Premarket Approval (PMA) submission consulting, FDA 513(g) classification requests, and FDA Q-Sub/Pre-Sub program guidance. With over 25 years of experience, MedEnvoy Global's executive management has served as FDA registered medical device US agents for over 500 overseas companies. Their Austin, Texas-based office ensures seamless communication with both your company and the FDA. They streamline compliance in your distribution chain, helping you meet specific country regulations and enter new markets seamlessly. MedEnvoy Global provides end-to-end support, from initial strategy development to final submission. Their team of experts helps identify regulatory pathways, develop robust plans, compile necessary documentation, and ensure your submissions meet the highest standards of clarity, completeness, and compliance. They are dedicated to removing barriers and providing clarity for your global regulatory needs.
About
**Who they are**
MedEnvoy Global is a regulatory consulting firm specializing in medical device market entry and compliance in the US and globally. They focus on empowering small and medium-sized companies in the health care and life sciences industry.
**Expertise & scope**
* Expert guidance for FDA submissions, registration, and Quality Management Systems (QMS).
* Specialized services include FDA 510(k) clearance consulting, FDA Premarket Approval (PMA) submission consulting, FDA 513(g) classification requests, and FDA Q-Sub/Pre-Sub program engagement.
* Assistance with FDA Quality System Regulation (QSR) compliance, including 21 CFR Part 820 and the upcoming QMSR (Quality Management System Regulations) which will align with ISO 13485:2016.
* US FDA Agent services for foreign establishments, acting as an official correspondent and providing FDA establishment and medical device registration support.
* Global regulatory representation, including EU Authorized Representative, UK Responsible Person, Swiss Authorized Representative, Mexico Registration Holder, and others.
**Reputation / proof points**
* Executive management has over 25 years of experience as an FDA registered medical device US agent for over 500 overseas medical device companies.
* Operates with a central office in Austin, Texas, ensuring accessibility to the FDA during business hours.
MedEnvoy Global is a regulatory consulting firm specializing in medical device market entry and compliance in the US and globally. They focus on empowering small and medium-sized companies in the health care and life sciences industry.
**Expertise & scope**
* Expert guidance for FDA submissions, registration, and Quality Management Systems (QMS).
* Specialized services include FDA 510(k) clearance consulting, FDA Premarket Approval (PMA) submission consulting, FDA 513(g) classification requests, and FDA Q-Sub/Pre-Sub program engagement.
* Assistance with FDA Quality System Regulation (QSR) compliance, including 21 CFR Part 820 and the upcoming QMSR (Quality Management System Regulations) which will align with ISO 13485:2016.
* US FDA Agent services for foreign establishments, acting as an official correspondent and providing FDA establishment and medical device registration support.
* Global regulatory representation, including EU Authorized Representative, UK Responsible Person, Swiss Authorized Representative, Mexico Registration Holder, and others.
**Reputation / proof points**
* Executive management has over 25 years of experience as an FDA registered medical device US agent for over 500 overseas medical device companies.
* Operates with a central office in Austin, Texas, ensuring accessibility to the FDA during business hours.
Additional information
MedEnvoy Global emphasizes a proactive approach to regulatory compliance, offering services designed to streamline market entry and ensure adherence to FDA requirements. Their expertise extends to navigating complex submission pathways such as 510(k), PMA, and the 513(g) process for device classification. They also facilitate early engagement with the FDA through the Q-Sub program to clarify device development plans and submission requirements. For manufacturers, understanding the evolving FDA Quality System Regulation (QSR) is crucial, and MedEnvoy Global provides guidance on current requirements (21 CFR Part 820) and the upcoming QMSR, which will incorporate ISO 13485:2016 standards.
Key Highlights
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Executive management has over 25 years of experience as an FDA registered medical device US agent for over 500 overseas companies.
Source
“Over the last 25+ years, MedEnvoy Global’s executive management has been an FDA registered medical device US agent for 500+ overseas medical device companies.”
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Provides comprehensive support for FDA 510(k) submissions, including strategy development and end-to-end process management.
Source
“From initial strategy development to the final submission, we offer end-to-end support throughout the FDA 510(k) process.”
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Offers expert guidance on FDA Premarket Approval (PMA) submissions for high-risk and novel Class III devices.
Source
“MedEnvoy’s team of experienced consultants has decades of experience preparing PMA submissions and working with manufacturers of high-risk devices.”
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Assists with FDA QSR compliance and the upcoming QMSR, which will integrate ISO 13485:2016 requirements.
Source
“FDA has set a release date of 2 February 2026 for their new quality system requirements, which have been rebranded as the QMSR (Quality Management System Regulations). The QMSR will rely upon ISO 13485:2016 with the addition of a few FDA-specific requirements”
Certifications & Trust Signals
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Established in the Netherlands by experienced regulatory affairs executives.
Source
“Established in the Netherlands by experienced and reputable regulatory affairs executives, MedEnvoy”
Buyer Snapshot
Best for
- Foreign medical device manufacturers seeking US FDA Agent services.
- Companies needing assistance with FDA submissions (510(k), PMA, 513(g), Q-Sub).
- Businesses requiring guidance on FDA QSR/QMSR compliance.
How engagement typically works
- Consultative approach to regulatory strategy.
- End-to-end support for submissions and compliance.
- Expert guidance and direct FDA interaction support.
Typical deliverables
- US FDA Agent designation and correspondence.
- Completed FDA submission dossiers (510(k), PMA, etc.).
- QSR/QMSR compliance strategy and implementation plans.
- Device classification determination support.
Good to know
- Best when requiring specialized US FDA regulatory expertise for medical devices and IVDs.
HQ:
Austin, US
Languages:
English
Timezones:
America/Chicago
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVDs
Portfolio:
6-25, 26-100, 100+
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 1,800
Included services:
FDA communications handling, Establishment registration support, Device listing assistance, Inspection coordination, Regulatory consulting
Registration Support:
Yes
Annual Renewal Support:
Yes
Annual Renewal Reminder:
Yes
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting
Additional us_agent_fda Details
Product Types
Medical Devices, IVDs
Registration Support
Yes, FDA establishment registration and medical device registration support is offered.
Inspection Support
Yes, QMS inspections are part of the PMA review process, and FDA reserves the right to conduct facility inspections.
US Entity State
Texas
Onboarding Steps
The process involves designating a US-based US FDA Agent with a physical location readily available to the FDA during standard business hours. MedEnvoy's office in Austin, Texas, serves this purpose.
Recall Support
Not explicitly stated, but implied through overall FDA compliance support.
Emergency Contact24x7
Not explicitly stated.
