Rook Quality Systems

Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems. For over a decade, Rook has specialized in Quality and Regulatory strategies for emerging medical device clientele. At Rook, our mission is to enable clients to implement compliant Quality Management Systems (QMSs) so that they can efficiently produce effective and reliable medical devices. We build these QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices. Rook provides clients with all of the right resources and necessary tools to comply with regulations in domestic and international markets. Rook's team provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class devices, SaMD, and IVDs). What's important to us at Rook Quality Systems: • Glass Half Full Approach: Running a business can be stressful, and audits can make it even more tense, but staying positive and working together towards a common goal is how we approach each project. We believe that through open communication, a positive attitude, and a team first approach any obstacle can be overcome. • Patients First: In the Medical Device field, the patient comes first. We strive to assist our clients to deliver Quality devices to the market in an efficient way. Ensuring quality through compliance so that safe and innovative devices get to the patients and users is our highest priority. • Proactive, Not Reactive: In an industry that's constantly changing, it's critical to stay up-to-date on current practices, the latest standards, and regulatory trends. We utilize the latest tools and quality improvements to continually make our processes more efficient, and to improve our service to our clients.