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 pre-market and post-market strategies.
* Develops tailored Quality Management Systems (QMS) and provides audit support, including representation during FDA inspections.
* 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 pre-market and post-market strategies.
* Develops tailored Quality Management Systems (QMS) and provides audit support, including representation during FDA inspections.
* 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. This role is critical for medical device and IVD companies seeking to access the U.S. market without a physical presence. They ensure compliance with FDA requirements and handle communications regarding any findings or corrective actions. Their services extend to comprehensive support throughout the product lifecycle, from initial market path planning and product definition to post-market surveillance and quality management.
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 US Agent services, ensuring compliance and market access.
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, QMS development, and postmarket surveillance.
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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They offer audit support and representation during FDA inspections and Notified Body audits.
Source
“Our team offers hands-on representation during FDA inspections, Notified Body audits, and customer audits, helping you navigate the process smoothly while maintaining full compliance.”
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”
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 support for regulatory pathways.
- Hands-on audit and inspection support.
Typical deliverables
- FDA Establishment Registration and Device Listing.
- US Agent representation and communication.
- Quality Management System (QMS) development and support.
- Postmarket Surveillance Program (PMS) implementation.
- Clinical study design and regulatory submission support.
Good to know
- Best when engaging for FDA U.S. Agent services and broader regulatory compliance needs.
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
No
Inspection Support
Yes
Emergency Contact24x7
No
US Entity State
Massachusetts
Onboarding Steps
The website content does not detail specific onboarding steps, required documents, timelines, or setup procedures.
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