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:
Cary, United States
Languages:
English
Timezones:
UTC-5
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, SaMD, Combination product
Years Experience:
50
Ex FDA:
Yes
Ex Notified Body:
Yes
Ex Big Medtech:
No
Engagement Models:
Outsourcing, Consulting, Staff Augmentation
Accepting New Clients:
Yes
Supports Estar:
No
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Response Time Hours:
48
