Fang Consulting
Fang Consulting is a medical consulting firm located in the United States. We specialize in providing regulatory, quality system and pre-market expertise to medical device companies. Our experienced team of consultants are dedicated to helping our clients navigate the complexities of the medical device industry and navigate the US and international regulatory landscape.
Our services include regulatory affairs consulting, quality system consulting, pre-market notification FDA 510(k)'s, investigational device exemptions (pre-IDE and IDE), pre-market approval (PMA) applications, product development protocols (PDP), post-market surveillance protocols, labeling, establishment registration and device listing, medical device reporting (MDR) and complaint handling, CE marking, vigilance reporting, standards and guidelines, FDA regulatory agency meetings, selection and interpretation of US and international quality system requirements, drafting ISO 13485 quality manuals and procedure, conducting gap analyses, pre-audits, and internal audits, developing Medical Device Reporting (MDR) and European vigilance reporting systems, performing regulatory audits, preparing Technical Files and Design Dossiers, managing Quality Systems for virtual companies, and communications for product field actions (safety alerts, product recalls, corrective actions).
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