RQM+
RQM+: FDA Regulatory Consulting for MedTech & Software Expertise
RQM+ is a full-service MedTech CRO specializing in FDA regulatory consulting, with a strong focus on software expertise. They assist medical device companies in navigating complex FDA regulatory pathways, including 510(k) submissions, De Novo applications, and Premarket Approval (PMA). RQM+ serves clients globally and helps them achieve successful market access.
About
RQM+ is a full-service MedTech CRO specializing in FDA regulatory consulting, with a strong focus on software expertise. They assist medical device companies in navigating complex FDA regulatory pathways, including 510(k) submissions, De Novo applications, and Premarket Approval (PMA). RQM+ serves clients globally and helps them achieve successful market access.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** RQM+
- **Years of experience:** 15
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** RQM+ is a MedTech CRO specializing in regulatory consulting. Without specific details from the 'About' and 'Services' sections, a comprehensive analysis is limited. However, their LinkedIn presence suggests a focus on helping MedTech companies navigate the regulatory landscape.
- **Unique value:** RQM+ provides regulatory consulting services as a MedTech CRO, assisting companies in navigating the complex regulatory landscape.
- **Ideal projects:** The ideal client for RQM+ would be a MedTech company seeking regulatory guidance and support, particularly in navigating FDA regulations and achieving market access.
- **Confidence score:** 50/100
- **Last analyzed:** Sun Dec 14 2025 01:05:48 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, international
- **Device classes:** class-ii, class-i
- **Specialties:** software-samd
- **Regulatory pathways:** 510k, de_novo, pma
- **Type:** firm
- **Company:** RQM+
- **Years of experience:** 15
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** RQM+ is a MedTech CRO specializing in regulatory consulting. Without specific details from the 'About' and 'Services' sections, a comprehensive analysis is limited. However, their LinkedIn presence suggests a focus on helping MedTech companies navigate the regulatory landscape.
- **Unique value:** RQM+ provides regulatory consulting services as a MedTech CRO, assisting companies in navigating the complex regulatory landscape.
- **Ideal projects:** The ideal client for RQM+ would be a MedTech company seeking regulatory guidance and support, particularly in navigating FDA regulations and achieving market access.
- **Confidence score:** 50/100
- **Last analyzed:** Sun Dec 14 2025 01:05:48 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, international
- **Device classes:** class-ii, class-i
- **Specialties:** software-samd
- **Regulatory pathways:** 510k, de_novo, pma
Key Highlights
- RQM+ is a MedTech CRO specializing in regulatory consulting. Without specific details from the 'About' and 'Services' sections, a comprehensive analysis is limited. However, their LinkedIn presence suggests a focus on helping MedTech companies navigate the regulatory landscape.
- RQM+ provides regulatory consulting services as a MedTech CRO, assisting companies in navigating the complex regulatory landscape.
Certifications & Trust Signals
- 15 years experience
Buyer Snapshot
Best for
- The ideal client for RQM+ would be a MedTech company seeking regulatory guidance and support, particularly in navigating FDA regulations and achieving market access.
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), De Novo, PMA
Device Types Supported:
SaMD, Medical device
Years Experience:
15
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
fixed_fee
Accepting New Clients:
No
