QA/RA Consulting Group, Inc.

QA/RA Consulting Group, Inc. is a medical device consulting firm founded in 2012, specializing in regulatory affairs, quality management, and product development services. The company delivers market access solutions to medical device manufacturers, combination device developers, IVD companies, and pharmaceutical firms—ranging from startups to Fortune 500 enterprises. QA/RA CG has supported over 225 clients with operations across 23 countries worldwide. Core service offerings include FDA regulatory compliance, US Initial Importer and Official Correspondent services, quality management system (QMS) development and implementation, and strategic commercialization consulting. The firm's team comprises experienced consultants with backgrounds in engineering, science, and regulatory affairs, including former industry quality and regulatory leaders with direct FDA interaction experience. Services span the full product lifecycle: design, development, manufacturing, marketing, and distribution of medical devices. QA/RA CG emphasizes customized, strategic solutions tailored to client-specific needs, combining efficiency with compliance across multiple regulatory jurisdictions and economic regions.