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 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 comprehensive medical products regulatory consulting services, including clinical services, quality management, and postmarket surveillance.
* Assists with clinical study design, trial management, data analysis, and regulatory submissions for FDA, EU MDR, and other international standards.
* Develops tailored Quality Management Systems (QMS) and provides audit support, including representation during FDA inspections and Notified Body audits.
* Supports Postmarket Surveillance (PMS) programs, including complaint handling and adverse event reporting.
**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 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 comprehensive medical products regulatory consulting services, including clinical services, quality management, and postmarket surveillance.
* Assists with clinical study design, trial management, data analysis, and regulatory submissions for FDA, EU MDR, and other international standards.
* Develops tailored Quality Management Systems (QMS) and provides audit support, including representation during FDA inspections and Notified Body audits.
* Supports Postmarket Surveillance (PMS) programs, including complaint handling and adverse event reporting.
**Reputation / proof points**
* Offices located in Amesbury, MA, USA; Witney, Oxfordshire, UK; and Barcelona, Spain.
Additional information
RQMIS acts as the FDA U.S. Agent, serving as the official correspondent for foreign establishments that lack a physical presence in the United States. This role is critical for medical device and In Vitro Diagnostic (IVD) companies seeking to access the U.S. market, ensuring compliance with FDA requirements. Their services extend to comprehensive regulatory support, clinical evidence generation, and the establishment of robust Quality Management Systems (QMS). They also provide specialized Postmarket Surveillance Service (PMSS) to help companies manage quality, reporting, and data analysis effectively, which is crucial for avoiding regulatory penalties and ensuring patient safety.
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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They specialize in FDA submissions and U.S. Agent services.
Source
“They specialize in FDA submissions, US Agent services, and navigating complex regulatory pathways to ensure market success.”
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RQMIS serves as the FDA U.S. Agent (Official Correspondent) for foreign establishments.
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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Services include clinical study design, data analysis, and regulatory submissions for FDA and EU MDR.
Source
“Our experienced team provides strategic guidance on clinical study design, clinical trial management, data analysis, regulatory submissions, and post-market clinical follow-up (PMCF) to ensure compliance with global requirements.”
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They offer tailored Quality Management Systems (QMS) and audit support, including FDA inspection representation.
Source
“RQMIS specializes in creating tailored Quality Management Systems (QMS) that align seamlessly with your organization’s unique business objectives.”
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RQMIS supports Postmarket Surveillance Service (PMSS), including complaint handling and adverse event reporting.
Source
“RQMIS will help identify, complete, and submit Adverse Event Reports to satisfy regulations.”
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 service provision as FDA U.S. Agent.
- Consultative approach for QMS and clinical strategy development.
Typical deliverables
- FDA U.S. Agent representation.
- FDA establishment registration and device listing support.
- Quality Management System (QMS) design and audit support.
- Clinical study design and regulatory submission support.
- Postmarket Surveillance program development and support.
Good to know
- Best when requiring specialized expertise in FDA regulations and U.S. market access.
Pricing
Model:
Custom pricing
HQ:
Amesbury, USA
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Find 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
No
Inspection Support
Yes
Emergency Contact24x7
No
US Entity State
MA
Onboarding Steps
RQMIS serves as the FDA U.S. Agent, providing reliable representation and ensuring compliance with FDA requirements for foreign establishments.
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