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
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.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Global Quality and Regulatory Services
- **Years of experience:** 12
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Global Quality and Regulatory Services (GQRS) offers unique value as an FDA-accredited 510(k) Third Party Review Organization, combining 12 years of experience with the authority to perform official 510(k) reviews. This dual capability provides clients with unparalleled insight into FDA expectations and review processes, significantly de-risking submissions by anticipating potential reviewer questions and ensuring compliance from the outset. Their specialization in Class I and Class II general hospital devices ensures deep, focused expertise in these specific product categories, enabling them to efficiently guide medical device companies through the 510(k) regulatory pathway to achieve successful clearances.
- **Unique value:** GQRS uniquely stands out as an FDA-accredited 510(k) Third Party Review Organization, offering clients the distinct advantage of having their regulatory consultant also be an authorized reviewer, providing an insider's perspective and potentially streamlining the entire 510(k) submission and review process.
- **Ideal projects:** The ideal client for GQRS is a medical device company, particularly small to mid-sized, seeking efficient and expert navigation of the 510(k) regulatory pathway for Class I or Class II general hospital devices. Projects best suited involve initial 510(k) submissions or those requiring a strategic approach to overcome previous challenges, where the benefit of an accredited third-party reviewer acting as a consultant can significantly expedite the clearance process. Companies valuing a fixed-project pricing structure and direct access to review-level expertise will find GQRS an excellent fit for their regulatory needs.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:16:18 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, regulatory strategy
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** Global Quality and Regulatory Services
- **Years of experience:** 12
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Global Quality and Regulatory Services (GQRS) offers unique value as an FDA-accredited 510(k) Third Party Review Organization, combining 12 years of experience with the authority to perform official 510(k) reviews. This dual capability provides clients with unparalleled insight into FDA expectations and review processes, significantly de-risking submissions by anticipating potential reviewer questions and ensuring compliance from the outset. Their specialization in Class I and Class II general hospital devices ensures deep, focused expertise in these specific product categories, enabling them to efficiently guide medical device companies through the 510(k) regulatory pathway to achieve successful clearances.
- **Unique value:** GQRS uniquely stands out as an FDA-accredited 510(k) Third Party Review Organization, offering clients the distinct advantage of having their regulatory consultant also be an authorized reviewer, providing an insider's perspective and potentially streamlining the entire 510(k) submission and review process.
- **Ideal projects:** The ideal client for GQRS is a medical device company, particularly small to mid-sized, seeking efficient and expert navigation of the 510(k) regulatory pathway for Class I or Class II general hospital devices. Projects best suited involve initial 510(k) submissions or those requiring a strategic approach to overcome previous challenges, where the benefit of an accredited third-party reviewer acting as a consultant can significantly expedite the clearance process. Companies valuing a fixed-project pricing structure and direct access to review-level expertise will find GQRS an excellent fit for their regulatory needs.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:16:18 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii
- **Specialties:** general-hospital, regulatory strategy
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
Key Highlights
- Global Quality and Regulatory Services (GQRS) offers unique value as an FDA-accredited 510(k) Third Party Review Organization, combining 12 years of experience with the authority to perform official 510(k) reviews. This dual capability provides clients with unparalleled insight into FDA expectations and review processes, significantly de-risking submissions by anticipating potential reviewer questions and ensuring compliance from the outset. Their specialization in Class I and Class II general h
- GQRS uniquely stands out as an FDA-accredited 510(k) Third Party Review Organization, offering clients the distinct advantage of having their regulatory consultant also be an authorized reviewer, providing an insider's perspective and potentially streamlining the entire 510(k) submission and review process.
Certifications & Trust Signals
- 12 years experience
Buyer Snapshot
Best for
- The ideal client for GQRS is a medical device company, particularly small to mid-sized, seeking efficient and expert navigation of the 510(k) regulatory pathway for Class I or Class II general hospital devices. Projects best suited involve initial 510(k) submissions or those requiring a strategic approach to overcome previous challenges, where the benefit of an accredited third-party reviewer acti
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k)
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
fixed_fee
Accepting New Clients:
No
