PQE Group
★★★★★
3.8
/ 5
•
31 reviews
FDA 510(k) Regulatory and Quality Consulting Firm - 12 Years Experience
PQE Group is a dedicated regulatory and quality consulting firm with 12 years of experience specializing in FDA 510(k) submissions. They offer comprehensive, all-in-one solutions to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. PQE Group serves clients globally, including in the US and EU, ensuring a thorough approach to regulatory compliance.
About
PQE Group is a dedicated regulatory and quality consulting firm with 12 years of experience specializing in FDA 510(k) submissions. They offer comprehensive, all-in-one solutions to help medical device companies successfully navigate FDA regulatory pathways and achieve 510(k) clearances. PQE Group serves clients globally, including in the US and EU, ensuring a thorough approach to regulatory compliance.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** PQE Group
- **Years of experience:** 12
- **Regions served:** US, EU
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** PQE Group is a regulatory affairs consulting firm specializing in FDA 510(k) submissions. They offer services to medical device companies seeking regulatory approval in the US market.
- **Unique value:** PQE Group provides regulatory affairs consulting services to help medical device companies navigate the FDA 510(k) submission process.
- **Ideal projects:** Their ideal client is a medical device company seeking assistance with the 510(k) submission process. This could range from startups to established companies.
- **Confidence score:** 60/100
- **Last analyzed:** Sun Dec 14 2025 01:05:47 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, qms
- **Device classes:** class-i, class-ii
- **Specialties:** regulatory strategy, quality system implementation, quality management systems
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** PQE Group
- **Years of experience:** 12
- **Regions served:** US, EU
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** PQE Group is a regulatory affairs consulting firm specializing in FDA 510(k) submissions. They offer services to medical device companies seeking regulatory approval in the US market.
- **Unique value:** PQE Group provides regulatory affairs consulting services to help medical device companies navigate the FDA 510(k) submission process.
- **Ideal projects:** Their ideal client is a medical device company seeking assistance with the 510(k) submission process. This could range from startups to established companies.
- **Confidence score:** 60/100
- **Last analyzed:** Sun Dec 14 2025 01:05:47 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, qms
- **Device classes:** class-i, class-ii
- **Specialties:** regulatory strategy, quality system implementation, quality management systems
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k
Key Highlights
- PQE Group is a regulatory affairs consulting firm specializing in FDA 510(k) submissions. They offer services to medical device companies seeking regulatory approval in the US market.
- PQE Group provides regulatory affairs consulting services to help medical device companies navigate the FDA 510(k) submission process.
Certifications & Trust Signals
- 12 years experience
Buyer Snapshot
Best for
- Their ideal client is a medical device company seeking assistance with the 510(k) submission process. This could range from startups to established companies.
HQ:
Rockville, United States
Languages:
English
Timezones:
EST, CET
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), 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
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
26
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
Multitasking teams
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Num510k Submitted:
15000
