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Fang Consulting

Regulatory Consultant

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.

Experience: 7+ years

Submissions: 15 510(k)

Expertise & Specializations

Regulatory Pathways

510kPmaDe NovoIde

Device Specialties

General-HospitalCardiovascularGastroenterologyUrologyOrthopedic

Regions Served

Fang Consulting provides regulatory consulting services to clients in:

European Union (MDR/IVDR)

Executive Summary

Professional Overview

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 ...

Core Specializations

Regulatory Pathways

510kPmaDe NovoIde

Device Specialties

General-HospitalCardiovascularGastroenterologyUrologyOrthopedic

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
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 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.

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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