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, ensuring compliance with FDA requirements.
* Offers comprehensive medical products regulatory consulting, including navigating global regulatory landscapes for efficient and compliant market entry.
* Provides clinical consulting services for generating evidence needed for regulatory approval and market success, with expertise in pre-market and post-market clinical strategies aligned with FDA, EU MDR, and international standards.
* Specializes in creating tailored Quality Management Systems (QMS), offering audit support, and providing hands-on representation during FDA inspections, Notified Body audits, and customer audits.
* Delivers Postmarket Surveillance Service (PMSS) programs, addressing regulatory expectations for robust processes in complaint handling, adverse event reporting, and data analysis to improve product quality and patient safety.
**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, ensuring compliance with FDA requirements.
* Offers comprehensive medical products regulatory consulting, including navigating global regulatory landscapes for efficient and compliant market entry.
* Provides clinical consulting services for generating evidence needed for regulatory approval and market success, with expertise in pre-market and post-market clinical strategies aligned with FDA, EU MDR, and international standards.
* Specializes in creating tailored Quality Management Systems (QMS), offering audit support, and providing hands-on representation during FDA inspections, Notified Body audits, and customer audits.
* Delivers Postmarket Surveillance Service (PMSS) programs, addressing regulatory expectations for robust processes in complaint handling, adverse event reporting, and data analysis to improve product quality and patient safety.
**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 without a physical presence in the United States to access the U.S. market and maintain compliance with FDA regulations. They also support companies in developing and implementing robust Postmarket Surveillance programs, which are essential for ongoing product quality and safety monitoring. Deficiencies in product complaint handling are noted as a top-cited issue in FDA Warning Letters, highlighting the importance of effective PMS programs.
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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Specializes in FDA submissions and US Agent services 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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Offers comprehensive clinical consulting services aligned with FDA, EU MDR, and international standards.
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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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 meet global regulatory requirements.
Source
“Global regulatory authorities impose stringent requirements for postmarket surveillance (PMS) programs, mandating robust processes for:”
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 seeking FDA U.S. Agent representation.
- Companies needing support with FDA submissions and regulatory pathways.
- Manufacturers requiring assistance with Quality Management Systems (QMS) and audits.
- Organizations needing to establish or improve Postmarket Surveillance programs.
How engagement typically works
- Provides direct representation as FDA U.S. Agent.
- Offers tailored consulting services for regulatory, clinical, and quality needs.
- Supports clients through FDA inspections and audits.
- Assists in developing and implementing compliance programs.
Typical deliverables
- FDA U.S. Agent services (Official Correspondent).
- Regulatory consulting and submission support.
- Clinical study design and management.
- Quality Management System (QMS) development and audit support.
- Postmarket Surveillance program implementation and complaint handling.
Good to know
- Best when requiring specialized expertise in FDA regulations for medical devices and IVDs.
- Ideal for companies without a physical U.S. presence.
- Suitable for organizations needing to navigate complex global regulatory landscapes.
Pricing
Model:
Custom pricing
HQ:
Amesbury, USA
Languages:
English
Timezones:
EST
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
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
The website content does not detail specific onboarding steps, required documents, timelines, or setup procedures.
