Rook Quality Systems Employee Directory
Medical Equipment ManufacturingGeorgia, United States11-50 Employees
Rook Quality Systems is a consulting firm based in Atlanta, Georgia, that helps early-stage medical device companies establish and maintain compliant quality management systems. With more than a decade of experience, the firm specializes in quality and regulatory strategies for emerging medical device clients, spanning devices from Class I to III, including software-based medical devices and IVDs. Its work focuses on enabling clients to implement QMSs that support efficient development and manufacturing, helping products reach the market faster and sustain high quality over time. The company provides guidance to meet regulatory requirements in both domestic and international markets, including FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity.
1-888-653-2347 
support@leadiq.com 
