Fang Consulting, Ltd.
Regulatory Consultant
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 e...
Experience: 7+ years
Submissions: 15 510(k)
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
Fang Consulting, Ltd. provides regulatory consulting services to clients in:
Executive Summary
Professional Overview
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 regulat...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Regions: EU
- Background: 7+ years of regulatory experience.
Cruxi view
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.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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