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.
Buyer Snapshot
Best for
- Companies seeking FDA authorization for medical devices.
- Manufacturers navigating the De Novo classification pathway.
- Businesses requiring EU MDR compliance support.
How engagement typically works
- Project-based consulting.
- Expert guidance on regulatory strategy.
- Submission preparation and management.
Typical deliverables
- FDA 510(k) submission packages.
- De Novo classification documentation.
- EU MDR compliance strategies.
- Quality Management System (QMS) development.
Good to know
- Best when requiring specialized expertise in FDA and EU medical device regulations.
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, neurology, orthopedic
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
On-site, Remote
