RQMIS
RQMIS provides expert regulatory, clinical, and quality consulting for medical device companies. They specialize in FDA submissions, US Agent services, and navigating complex regulatory pathways to ensure market success.
RQMIS is a premier consulting firm dedicated to guiding medical device and IVD companies through the complexities of regulatory compliance and market access. With a strong focus on FDA submissions, including 510(k) repairs and DeNovo applications, RQMIS ensures your products meet all necessary requirements for US market entry. They offer specialized US Agent services, acting as your official correspondent with the FDA, which is critical for foreign establishments. Their expertise extends to managing FDA inspections, addressing warning letters, and providing comprehensive support for combination products. RQMIS leverages deep industry knowledge to streamline the path to market, offering solutions for product definition, design, manufacturing, and post-market surveillance. Whether you need assistance with quality management systems, clinical services, or navigating European regulations as an Authorized Representative, RQMIS is equipped to deliver tailored strategies for success.
About
**Who they are**
RQMIS provides expert regulatory, clinical, and quality consulting for medical device companies, specializing in FDA submissions and US Agent services to ensure market success.
**Expertise & scope**
* Serves as an FDA U.S. Agent (Official Correspondent) for foreign medical device and IVD companies without a U.S. physical presence.
* Facilitates FDA registration and compliance with FDA requirements.
* Offers a full suite of clinical consulting services for generating evidence needed for regulatory approval and market success, including clinical study design, trial management, data analysis, regulatory submissions, and post-market clinical follow-up (PMCF).
* Specializes in creating tailored Quality Management Systems (QMS) and provides audit support, including hands-on representation during FDA inspections and Notified Body audits.
* Provides Postmarket Surveillance Service (PMSS) to help structure and support complaint handling and adverse event reporting programs, identifying and submitting adverse event reports to satisfy regulations.
* Supports clients in navigating complex regulatory pathways, including FDA, EU MDR, and other international standards.
**Reputation / proof points**
* Offices located in Amesbury, MA, USA; Witney, Oxfordshire, UK; and Barcelona, Spain.
RQMIS provides expert regulatory, clinical, and quality consulting for medical device companies, specializing in FDA submissions and US Agent services to ensure market success.
**Expertise & scope**
* Serves as an FDA U.S. Agent (Official Correspondent) for foreign medical device and IVD companies without a U.S. physical presence.
* Facilitates FDA registration and compliance with FDA requirements.
* Offers a full suite of clinical consulting services for generating evidence needed for regulatory approval and market success, including clinical study design, trial management, data analysis, regulatory submissions, and post-market clinical follow-up (PMCF).
* Specializes in creating tailored Quality Management Systems (QMS) and provides audit support, including hands-on representation during FDA inspections and Notified Body audits.
* Provides Postmarket Surveillance Service (PMSS) to help structure and support complaint handling and adverse event reporting programs, identifying and submitting adverse event reports to satisfy regulations.
* Supports clients in navigating complex regulatory pathways, including FDA, EU MDR, and other international standards.
**Reputation / proof points**
* Offices located in Amesbury, MA, USA; Witney, Oxfordshire, UK; and Barcelona, Spain.
Additional information
RQMIS emphasizes the critical need for an FDA-registered U.S. Agent for foreign medical device and IVD companies seeking to access the U.S. market. They act as the official correspondent, ensuring compliance and reliable representation. Their services extend to comprehensive clinical support, quality management system development, and robust post-market surveillance, all crucial for navigating global regulatory landscapes and achieving market success. Buyers should consider RQMIS for end-to-end support from initial market entry strategy through post-market compliance.
Key Highlights
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RQMIS provides expert regulatory, clinical, and quality consulting for medical device companies.
Source
“RQMIS provides expert regulatory, clinical, and quality consulting for medical device companies.”
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Serves as an FDA U.S. Agent (Official Correspondent) for foreign establishments without a U.S. presence.
Source
“At RQMIS, we serve as your FDA U.S. Agent (Official Correspondent), providing reliable representation and ensuring compliance with FDA requirements.”
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Offers comprehensive clinical consulting services for regulatory approval and market success.
Source
“RQMIS offers a full suite of clinical consulting services designed to support medical device manufacturers in generating the evidence needed for regulatory approval and market success.”
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Specializes in creating tailored Quality Management Systems (QMS) and provides audit support.
Source
“RQMIS specializes in creating tailored Quality Management Systems (QMS) that align seamlessly with your organization’s unique business objectives.”
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Provides Postmarket Surveillance Service (PMSS) to support complaint handling and adverse event reporting.
Source
“A well-structured postmarket surveillance system, supported by adequate resources and advanced analytical tools, empowers manufacturers to:”
Certifications & Trust Signals
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RQMIS has offices in the USA, UK, and Spain.
Source
“110 Haverhill Road Suite # 524 Amesbury, MA, 01913 USA 4 Whitan Way Witney Oxfordshire, OX28 6FF United Kingdom Barcelona Health Hub, Recinte Modernista de Sant Pau Carrer de Sant Antoni Maria Claret, 167, Horta-Guinardo Barcelona, Catalunya, CP:08025 Spain”
Buyer Snapshot
Best for
- Foreign medical device and IVD companies needing an FDA U.S. Agent.
- Companies seeking comprehensive regulatory, clinical, and quality consulting.
How engagement typically works
- Direct representation as FDA U.S. Agent.
- Consultative partnership for regulatory strategy and execution.
Typical deliverables
- FDA Establishment Registration and U.S. Agent services.
- Clinical study design and management.
- Quality Management System (QMS) development and audit support.
- Postmarket Surveillance Program (PMS) structuring and support.
Good to know
- Best when requiring specialized support for U.S. FDA regulations and market access.
Pricing
Model:
Custom pricing
HQ:
Amesbury, USA
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Registration Support:
Yes
Annual Renewal Support:
Yes
Inspection Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
No
Product Type:
devices
Time Zone Coverage:
USA, United Kingdom, Spain
Recall Support:
No
Additional us_agent_fda Details
Product Types
Medical Devices, In Vitro Diagnostics (IVD), Combination Products
Registration Support
Yes
Recall Support
Yes
Inspection Support
Yes
Emergency Contact24x7
No
US Entity State
MA
Onboarding Steps
RQMIS acts as the FDA U.S. Agent, providing reliable representation and ensuring compliance with FDA requirements for foreign establishments.
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