Fang Consulting
Fang Consulting – FDA Regulatory & QMS Expert for Medical Devices
Fang Consulting offers specialized FDA regulatory consulting for medical device companies, focusing on strategic guidance and robust quality management systems. Their expertise encompasses regulatory pathway assessment, comprehensive ISO 13485 QMS consulting, and ISO 14971 risk management, ensuring clients navigate complex regulatory landscapes effectively.
About
Fang Consulting offers specialized FDA regulatory consulting for medical device companies, focusing on strategic guidance and robust quality management systems. Their expertise encompasses regulatory pathway assessment, comprehensive ISO 13485 QMS consulting, and ISO 14971 risk management, ensuring clients navigate complex regulatory landscapes effectively.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Fang Consulting
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Regions served:** EU
- **Location:** EU
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Fang Consulting offers expertise in regulatory affairs and quality assurance for the medical device industry. They focus on providing customized solutions to meet client needs, indicating a flexible and client-centered approach. Their services include QMS setup and support for regulatory submissions.
- **Unique value:** Fang Consulting provides customized regulatory and quality solutions for medical device companies, with a focus on QMS and regulatory submissions.
- **Ideal projects:** The ideal client is a medical device company, possibly a startup or SME, seeking assistance with regulatory strategy, quality system implementation, or navigating the regulatory submission process. Companies needing support with ISO 13485 or ISO 14971 would also be a good fit.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, de_novo, investigational_device_exemption
- **Specialties:** regulatory strategy, quality management systems, risk management, quality system implementation
- **Device panels:** general-hospital, cardiovascular, gastroenterology, urology, orthopedic, neurology
- **Regulatory pathways:** 510k, pma, de_novo, ide
- **Type:** independent
- **Company:** Fang Consulting
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Regions served:** EU
- **Location:** EU
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Fang Consulting offers expertise in regulatory affairs and quality assurance for the medical device industry. They focus on providing customized solutions to meet client needs, indicating a flexible and client-centered approach. Their services include QMS setup and support for regulatory submissions.
- **Unique value:** Fang Consulting provides customized regulatory and quality solutions for medical device companies, with a focus on QMS and regulatory submissions.
- **Ideal projects:** The ideal client is a medical device company, possibly a startup or SME, seeking assistance with regulatory strategy, quality system implementation, or navigating the regulatory submission process. Companies needing support with ISO 13485 or ISO 14971 would also be a good fit.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, de_novo, investigational_device_exemption
- **Specialties:** regulatory strategy, quality management systems, risk management, quality system implementation
- **Device panels:** general-hospital, cardiovascular, gastroenterology, urology, orthopedic, neurology
- **Regulatory pathways:** 510k, pma, de_novo, ide
Key Highlights
- Fang Consulting offers expertise in regulatory affairs and quality assurance for the medical device industry. They focus on providing customized solutions to meet client needs, indicating a flexible and client-centered approach. Their services include QMS setup and support for regulatory submissions.
- Fang Consulting provides customized regulatory and quality solutions for medical device companies, with a focus on QMS and regulatory submissions.
Certifications & Trust Signals
- 7 years experience
- 15 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client is a medical device company, possibly a startup or SME, seeking assistance with regulatory strategy, quality system implementation, or navigating the regulatory submission process. Companies needing support with ISO 13485 or ISO 14971 would also be a good fit.
HQ:
EU
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, De Novo Strategy & Authoring, PMA Strategy & Support, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA
Device Types Supported:
Medical device, IVD
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:
general-hospital, cardiovascular, gastroenterology, urology, orthopedic, neurology
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Consultant Strategist, Team managed by a Senior Consultant
