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.
Buyer Snapshot
Best for
- Medical device companies seeking FDA 510(k) clearance.
- Companies navigating the EU MDR transition.
- Firms needing expert regulatory affairs support.
How engagement typically works
- Project-based assistance for submissions.
- Consultative support for regulatory strategy.
- Guidance on compliance system implementation.
Typical deliverables
- Completed 510(k) submission packages.
- Regulatory strategy reports.
- Gap assessment reports for EU MDR.
- Quality Management System documentation.
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, 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
