Fang Consulting, Ltd.
Fang Consulting, Ltd. – FDA 510(k) & regulatory consulting | Quality Assurance | Risk Management
Fang Consulting, Ltd. is a dedicated FDA regulatory consulting firm specializing in medical device compliance. With 7 years of experience, they provide expert guidance on regulatory strategy, quality assurance, risk management, and 510(k) submissions. Their services encompass a wide range of regulatory pathways, including pre-submission meetings, IDE, and PMA applications, with a strong focus on ensuring medical device compliance. Fang Consulting also offers valuable staff augmentation and technical writing services.
About
Fang Consulting, Ltd. is a dedicated FDA regulatory consulting firm specializing in medical device compliance. With 7 years of experience, they provide expert guidance on regulatory strategy, quality assurance, risk management, and 510(k) submissions. Their services encompass a wide range of regulatory pathways, including pre-submission meetings, IDE, and PMA applications, with a strong focus on ensuring medical device compliance. Fang Consulting also offers valuable staff augmentation and technical writing services.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Fang Consulting, Ltd.
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Regions served:** EU
- **Location:** EU (N/A)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Fang Consulting specializes in regulatory affairs and quality assurance for medical devices. They offer customized consulting services and staff augmentation to meet the regulatory and quality needs of medical device companies.
- **Unique value:** Fang Consulting provides comprehensive regulatory and quality solutions, combining expertise in regulatory submissions with a focus on building reliable quality management systems for medical device manufacturers.
- **Ideal projects:** Medical device companies, including startups, SMEs, and large medtech firms, seeking expert support in regulatory submissions, quality management system (QMS) development, and compliance with regulations like ISO 13485 and EU MDR.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pre-submission, investigational_device_exemption, pma
- **Specialties:** regulatory strategy, risk management
- **Device panels:** general hospital, cardiovascular, gastroenterology, urology, neurology, orthopedic
- **Regulatory pathways:** 510k, de_novo, pre-submission, ide
- **Type:** independent
- **Company:** Fang Consulting, Ltd.
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Regions served:** EU
- **Location:** EU (N/A)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Fang Consulting specializes in regulatory affairs and quality assurance for medical devices. They offer customized consulting services and staff augmentation to meet the regulatory and quality needs of medical device companies.
- **Unique value:** Fang Consulting provides comprehensive regulatory and quality solutions, combining expertise in regulatory submissions with a focus on building reliable quality management systems for medical device manufacturers.
- **Ideal projects:** Medical device companies, including startups, SMEs, and large medtech firms, seeking expert support in regulatory submissions, quality management system (QMS) development, and compliance with regulations like ISO 13485 and EU MDR.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pre-submission, investigational_device_exemption, pma
- **Specialties:** regulatory strategy, risk management
- **Device panels:** general hospital, cardiovascular, gastroenterology, urology, neurology, orthopedic
- **Regulatory pathways:** 510k, de_novo, pre-submission, ide
Key Highlights
- Fang Consulting specializes in regulatory affairs and quality assurance for medical devices. They offer customized consulting services and staff augmentation to meet the regulatory and quality needs of medical device companies.
- Fang Consulting provides comprehensive regulatory and quality solutions, combining expertise in regulatory submissions with a focus on building reliable quality management systems for medical device manufacturers.
Certifications & Trust Signals
- 7 years experience
- 15 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Medical device companies, including startups, SMEs, and large medtech firms, seeking expert support in regulatory submissions, quality management system (QMS) development, and compliance with regulations like ISO 13485 and EU MDR.
HQ:
EU
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), De Novo, 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:
general hospital, cardiovascular, gastroenterology, urology, neurology, orthopedic
Accepting New Clients:
Yes
