Rook Quality Systems

Rook Quality Systems is a consulting firm that specializes in quality and regulatory strategies for medical device companies, particularly those in early stages or emerging markets. Founded in 2012 by CEO Kyle Rose, the firm provides expert guidance to help manufacturers develop and maintain effective Quality Management Systems (QMS) that ensure compliance with industry standards and accelerate time to market. The company offers a range of services, including the development of customized QMS, hands-on consulting for design history files, risk management, and regulatory submission support. Rook also assists with audit preparation and execution, leveraging a team of certified auditors to help clients navigate various audits confidently. With a focus on practical solutions, Rook aims to keep QMS lean and efficient, avoiding unnecessary complexity that can hinder product development. With a team of around 40 consultants and a global presence, Rook Quality Systems supports nearly 150 medical device clients worldwide, including startups and established firms across various device classes. Their mission is to act as a strategic partner in the medical device development process, ensuring that quality and regulatory moves are optimized for success.

• Employees 26
• Founded 2012