J&J
J&J – FDA 510(k) & Regulatory Consulting for Medical Devices
J&J is a dedicated FDA regulatory consultant with 10 years of experience, specializing in guiding medical device companies through complex regulatory pathways. They offer comprehensive expertise in regulatory compliance, quality management systems, risk management, and auditing.
About
J&J is a dedicated FDA regulatory consultant with 10 years of experience, specializing in guiding medical device companies through complex regulatory pathways. They offer comprehensive expertise in regulatory compliance, quality management systems, risk management, and auditing.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 10
- **510(k)s submitted (self-reported):** 15
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This is a guide to regulatory consulting firms, not a profile of a specific firm. The strength lies in providing information to entrepreneurs to help them find the right partner to navigate regulatory compliance and accelerate their path to market.
- **Unique value:** This guide helps businesses view regulatory compliance as a competitive advantage by finding the right consulting partner.
- **Ideal projects:** Entrepreneurs and companies seeking expert regulatory consulting firms to help them navigate complex requirements, accelerate market entry, and build trust with customers.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pre-submission, clinical-trials, qms
- **Specialties:** quality management systems, risk management, preclinical testing, clinical trials
- **Device panels:** general hospital, cardiovascular, neurology, orthopedic, gastroenterology, urology
- **Regulatory pathways:** 510k, pre-submission, ide
- **Type:** independent
- **Years of experience:** 10
- **510(k)s submitted (self-reported):** 15
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This is a guide to regulatory consulting firms, not a profile of a specific firm. The strength lies in providing information to entrepreneurs to help them find the right partner to navigate regulatory compliance and accelerate their path to market.
- **Unique value:** This guide helps businesses view regulatory compliance as a competitive advantage by finding the right consulting partner.
- **Ideal projects:** Entrepreneurs and companies seeking expert regulatory consulting firms to help them navigate complex requirements, accelerate market entry, and build trust with customers.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pre-submission, clinical-trials, qms
- **Specialties:** quality management systems, risk management, preclinical testing, clinical trials
- **Device panels:** general hospital, cardiovascular, neurology, orthopedic, gastroenterology, urology
- **Regulatory pathways:** 510k, pre-submission, ide
Key Highlights
- This is a guide to regulatory consulting firms, not a profile of a specific firm. The strength lies in providing information to entrepreneurs to help them find the right partner to navigate regulatory compliance and accelerate their path to market.
- This guide helps businesses view regulatory compliance as a competitive advantage by finding the right consulting partner.
Certifications & Trust Signals
- 10 years experience
- 15 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Entrepreneurs and companies seeking expert regulatory consulting firms to help them navigate complex requirements, accelerate market entry, and build trust with customers.
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), Special 510(k), Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
10
Num510k Submitted:
15
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general hospital, cardiovascular, neurology, orthopedic, gastroenterology, urology
Accepting New Clients:
Yes
