QA/RA Consulting Group, Inc.
QA/RA Consulting Group, Inc. offers expert regulatory affairs, quality management, and product development services for medical devices, IVDs, and combination devices. They specialize in FDA US Agent and Official Correspondent services for international clients.
Founded in 2012 and based in Pittsburgh, Pennsylvania, QA/RA Consulting Group, Inc. (QA/RA CG) is a leader in providing comprehensive quality, regulatory, and compliance services for medical devices, IVDs, and combination devices. They assist clients globally, from startups to Fortune 500 companies, in achieving ambitious commercialization goals while ensuring necessary compliance levels. Their expertise spans the entire product lifecycle, including design, development, manufacturing, marketing, and distribution. QA/RA CG offers specialized services such as Regulatory Affairs, Quality Management Systems, Auditing, QA/RA Outsourcing, Design and Development, and U.S. Agent/Initial Importer Services. They are particularly adept at navigating global regulatory requirements and have prior direct interaction with regulators. For international clients, QA/RA Consulting Group provides crucial FDA U.S. Agent and Official Correspondent services, acting as the initial point of contact with the FDA. They handle communications, respond to FDA inquiries, and ensure foreign manufacturers meet registration requirements. Their approach is characterized by clear, effective, and frequent communication, direct leadership involvement, and a commitment to building strong partnerships based on trust and integrity.
About
**Who they are**
QA/RA Consulting Group, Inc. is a leader in medical device, IVD, and combination device quality, regulatory, and compliance services, based in Pittsburgh, Pennsylvania. They position their clients for success by leveraging extensive experience and expertise.
**Expertise & scope**
* Expert regulatory affairs, quality management, and product development services for medical devices, IVDs, and combination devices.
* Specialization in FDA U.S. Agent and Official Correspondent services for international clients.
* Support for FDA Establishment Registration and Device Listing.
* Guidance for FDA Warning Letters and 483 responses.
* Services related to CE Marking and European MDR compliance.
* Assistance with PMA and 510(k) submissions.
* U.S. Initial Importer services.
**Reputation / proof points**
* Network of consultants across the United States and Europe.
* Provides comprehensive and audit-ready solutions to companies of all sizes, from start-up to Fortune 500.
* Member of JumpStart Partners, the Pittsburgh Technology Council, and the Pennsylvania Biotechnology Association.
QA/RA Consulting Group, Inc. is a leader in medical device, IVD, and combination device quality, regulatory, and compliance services, based in Pittsburgh, Pennsylvania. They position their clients for success by leveraging extensive experience and expertise.
**Expertise & scope**
* Expert regulatory affairs, quality management, and product development services for medical devices, IVDs, and combination devices.
* Specialization in FDA U.S. Agent and Official Correspondent services for international clients.
* Support for FDA Establishment Registration and Device Listing.
* Guidance for FDA Warning Letters and 483 responses.
* Services related to CE Marking and European MDR compliance.
* Assistance with PMA and 510(k) submissions.
* U.S. Initial Importer services.
**Reputation / proof points**
* Network of consultants across the United States and Europe.
* Provides comprehensive and audit-ready solutions to companies of all sizes, from start-up to Fortune 500.
* Member of JumpStart Partners, the Pittsburgh Technology Council, and the Pennsylvania Biotechnology Association.
Additional information
QA/RA Consulting Group, Inc. serves as the initial point of contact between international clients and the FDA, offering peace of mind through their direct experience. They emphasize handling each issue with care and urgency. Foreign manufacturers are required to appoint a U.S. Agent during Establishment Registration, a requirement that applies to various foreign establishments including contract manufacturers, foreign exporters, and specification developers.
Key Highlights
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Specializes in FDA U.S. Agent and Official Correspondent services for international clients.
Source
“QA/RA Consulting Group, Inc. provides US Agent and Official Correspondent services to international clients.”
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Offers comprehensive regulatory affairs, quality management, and product development services for medical devices, IVDs, and combination devices.
Source
“QA/RA Consulting Group provides a comprehensive range of services in Quality, Regulatory Affairs, Product Development, and Human Factors / Usability for medical device and IVD companies.”
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Provides support for FDA Establishment Registration and Device Listing.
Source
“Establishment Registration and Device Listing”
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Offers FDA Warning Letter / 483 Support.
Source
“FDA Warning Letter / 483 Support”
Certifications & Trust Signals
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Based in Pittsburgh, Pennsylvania, with a network of consultants across the United States and Europe.
Source
“QA/RA is based in Pittsburgh, Pennsylvania, one of the world’s fastest-growing hubs for the medical device industry, with a network of consultants across the United States and Europe.”
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Member of JumpStart Partners, the Pittsburgh Technology Council, and the Pennsylvania Biotechnology Association.
Source
“QA/RA is also a proud member of JumpStart Partners, the Pittsburgh Technology Council, and the Pennsylvania Biotechnology Association.”
Buyer Snapshot
Best for
- International manufacturers needing FDA U.S. Agent services
- Companies seeking regulatory affairs and quality management support for medical devices, IVDs, and combination products
- Businesses requiring assistance with FDA submissions and compliance
How engagement typically works
- Clear and effective communication
- Frequent communication and accountability
- Direct involvement of company leadership
Typical deliverables
- FDA U.S. Agent representation
- Official Correspondent services
- Establishment Registration and Device Listing
- Regulatory strategy development
- Quality Management System implementation
- PMA and 510(k) submission support
Good to know
- Best when requiring specialized FDA regulatory expertise for international clients.
HQ:
Pittsburgh, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD
Portfolio:
6-25
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 600
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Registration Support:
Yes
Emergency Contact24x7:
Yes
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, Product/Device Listing, Regulatory Consulting
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Contact via form or email, specify company name and requirements. Response typically within 24 hours.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Medical devices, IVDs, Combination devices
Registration Support
Yes
Recall Support
Yes, through FDA Warning Letter / 483 Support
US Entity State
Pennsylvania
Inspection Support
Yes (FDA Warning Letter / 483 Support)
