Rook Quality Systems

Rook Quality Systems is a Quality Consulting Firm specializing in Quality and Regulatory Strategy for emerging Medical Device Companies. We work closely with your team to help get your device to market, faster.

Our vision is to enable our clients to implement compliant Quality Management Systems (QMSs) so to ensure our clients can efficiently produce effective and reliable medical devices. We want to build these QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, use these systems to continue producing quality devices.

Our consultants provide our clients with the necessary tools to comply with regulations in domestic and international markets. Rook QS provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class I-III 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 important that we stay on our toes. We strive 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 improve our service to our clients.

Company’s Keywords:

iso 13485, 510 clearance, medical device quality systems, medical device software validation, quality assurance, postmarket surveillance, internal audits, employee training