Global Quality and Regulatory Services
FDA 510(k) Third Party Review Organization | Expert Regulatory Consulting | Class I & II Devices
Global Quality and Regulatory Services (GQRS) is a specialized consulting firm with 12 years of experience focused on FDA 510(k) regulatory consulting. As an FDA-accredited 510(k) Third Party Review Organization, GQRS offers unique expertise to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. Their in-depth knowledge ensures efficient and compliant submissions.
About
**Who they are**
Global Quality and Regulatory Services (GQRS) is an FDA-accredited third-party reviewer specializing in 510(k) submissions for medical device manufacturers and distributors seeking to launch their products in the US market.
**Expertise & scope**
* FDA-accredited 510(k) third-party review organization.
* Expertise in Class I & II devices.
* Streamlined review process designed to significantly reduce FDA review time, potentially saving up to 70% compared to the standard FDA timeline.
* Offers a single, competitive fee that covers the review and communication with the FDA, with no additional FDA User Fees or hidden costs.
* Provides unlimited real-time communication and accommodates client deadlines.
* Offers comprehensive regulatory compliance services, including Quality Management System (QMS) creation, GxP pre-approval and surveillance inspections, and auditing of various partners and sites.
* Supports global regulatory processes with experience in North America, Latin America, Europe, Japan, and China.
**Reputation / proof points**
* Experienced team of reviewers dedicated to efficient submission processing.
* Focus on delivering excellent customer service and fostering open, honest client relationships.
Global Quality and Regulatory Services (GQRS) is an FDA-accredited third-party reviewer specializing in 510(k) submissions for medical device manufacturers and distributors seeking to launch their products in the US market.
**Expertise & scope**
* FDA-accredited 510(k) third-party review organization.
* Expertise in Class I & II devices.
* Streamlined review process designed to significantly reduce FDA review time, potentially saving up to 70% compared to the standard FDA timeline.
* Offers a single, competitive fee that covers the review and communication with the FDA, with no additional FDA User Fees or hidden costs.
* Provides unlimited real-time communication and accommodates client deadlines.
* Offers comprehensive regulatory compliance services, including Quality Management System (QMS) creation, GxP pre-approval and surveillance inspections, and auditing of various partners and sites.
* Supports global regulatory processes with experience in North America, Latin America, Europe, Japan, and China.
**Reputation / proof points**
* Experienced team of reviewers dedicated to efficient submission processing.
* Focus on delivering excellent customer service and fostering open, honest client relationships.
Additional information
Global Quality and Regulatory Services emphasizes a collaborative and interactive review process, aiming to get devices to market faster. They offer a transparent pricing structure with a single fee for their 510(k) review services, which includes direct communication with the FDA on behalf of the client. This approach is designed to streamline the path to market entry. For broader regulatory needs, they provide services such as QMS development, training, and auditing, supporting clients throughout the product lifecycle and across multiple global regions.
Key Highlights
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FDA-accredited 510(k) Third Party Review Organization.
Source
“FDA-accredited reviewer of 510(k) submissions for an extensive list of medical devices eligible for a third-party review.”
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Potential to save up to 70% of FDA review time.
Source
“can save you up to 70% of the FDA review time (average of 50-60 with GQRS vs 177 days).”
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Offers a single, competitive fee with no additional FDA User Fees or hidden costs.
Source
“One competitive fee to conduct the review and communicate with the FDA on your behalf - No additional FDA User Fee or any hidden costs.”
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Provides unlimited real-time communication with clients.
Source
“offer you unlimited real-time communications with us.”
Certifications & Trust Signals
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Experienced team of reviewers.
Source
“We are a large team of highly experienced reviewers dedicated to seamlessly reviewing your submission.”
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Supports global regulatory processes with experience in North America, Latin America, Europe, Japan, and China.
Source
“With our vast experience in regulations in North America, Latin America, Europe, Japan, and China, we support the harmonization of global processes”
Buyer Snapshot
Best for
- Medical device manufacturers and distributors needing US market access.
- Companies seeking to expedite their 510(k) submission review process.
- Clients who value direct communication and a streamlined workflow.
How engagement typically works
- Interactive and communicative review process.
- Accommodates client deadlines.
- Unlimited real-time communication.
Typical deliverables
- FDA 510(k) third-party review reports.
- FDA communication on behalf of the client.
- Quality Management System (QMS) development.
- Regulatory compliance consulting.
Good to know
- Best when clients have Class I or Class II devices eligible for third-party review.
- Best when clients prioritize speed to market and predictable costs.
Pricing
Model:
Custom pricing
HQ:
Monroe, United States
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Traditional 510(k) Support, Special 510(k) Support, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k)
Device Types Supported:
Medical device
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Years Experience:
150
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
Project-based
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
