PCG
PCG – U.S. FDA Regulatory Consulting for Medical Devices
PCG is a dedicated U.S. FDA regulatory consulting firm specializing in comprehensive support for medical device companies. With 7 years of experience, PCG excels in navigating the complexities of FDA regulatory pathways, including 510(k) submissions, de novo applications, PMA, and investigational device exemptions (IDE). Their expertise encompasses regulatory submissions, quality management systems, U.S. FDA compliance, premarket submissions, and postmarket surveillance, ensuring clients achieve and maintain compliance.
About
PCG is a dedicated U.S. FDA regulatory consulting firm specializing in comprehensive support for medical device companies. With 7 years of experience, PCG excels in navigating the complexities of FDA regulatory pathways, including 510(k) submissions, de novo applications, PMA, and investigational device exemptions (IDE). Their expertise encompasses regulatory submissions, quality management systems, U.S. FDA compliance, premarket submissions, and postmarket surveillance, ensuring clients achieve and maintain compliance.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Regions served:** US
- **Location:** US (California)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This firm's strength lies in its focus on U.S. FDA regulatory consulting. However, without more information, a detailed analysis is difficult.
- **Unique value:** A U.S. FDA regulatory consulting firm.
- **Ideal projects:** The ideal project would be a medical device company seeking assistance with FDA regulatory submissions in the US.
- **Confidence score:** 20/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, investigational_device_exemption
- **Specialties:** quality management systems
- **Device panels:** cardiovascular, orthopedic, neurology, gastroenterology
- **Regulatory pathways:** 510k, de_novo, pma, ide, pre-submission
- **Type:** independent
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Regions served:** US
- **Location:** US (California)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This firm's strength lies in its focus on U.S. FDA regulatory consulting. However, without more information, a detailed analysis is difficult.
- **Unique value:** A U.S. FDA regulatory consulting firm.
- **Ideal projects:** The ideal project would be a medical device company seeking assistance with FDA regulatory submissions in the US.
- **Confidence score:** 20/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, investigational_device_exemption
- **Specialties:** quality management systems
- **Device panels:** cardiovascular, orthopedic, neurology, gastroenterology
- **Regulatory pathways:** 510k, de_novo, pma, ide, pre-submission
Key Highlights
- This firm's strength lies in its focus on U.S. FDA regulatory consulting. However, without more information, a detailed analysis is difficult.
- A U.S. FDA regulatory consulting firm.
Certifications & Trust Signals
- 7 years experience
- 15 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project would be a medical device company seeking assistance with FDA regulatory submissions in the US.
HQ:
US
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, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
7
Num510k Submitted:
15
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, orthopedic, neurology, gastroenterology
Accepting New Clients:
Yes
