Fang Consulting

Fang Consulting is a private U.S. medical device consulting firm that provides regulatory affairs, quality assurance, and related project support services to medical device companies. Founded in 1999, the company works with clients ranging from startups to large global manufacturers, supporting both pre-market and post-market activities across the device lifecycle. Its service offerings include FDA and international regulatory strategy, 510(k), De Novo and PMA submission support, quality management system implementation and remediation, and device fulfillment support. Fang Consulting operates as a services business rather than a therapeutics developer, so it does not maintain a drug pipeline; its core value proposition is helping medical device companies navigate complex compliance and commercialization requirements.