A Quality Management System (QMS) provides a structured framework to ensure medical devices meet regulatory standards like FDA Quality Management System Regulations (QMSR) and ISO 13485 while maintaining consistent quality.
Rook Quality Systems helps companies design, implement, manage and optimize their QMS, streamlining compliance, automating critical tasks, and improving efficiency across the product lifecycle.
Our Quality Management Services
- Custom QMS Creation
- QMS Implementation
- QMS Maintenance & Management
- QMS Compliance Gap Assessment
- QMSR and ISO 13485 Compliance
- EU MDR QMS Compliance
Custom QMS Design
Rook’s team of quality engineers will design a custom QMS for your company that is both efficient and easy to maintain for your product and scope. Our systems are audit ready, and continually updated to ensure compliance with effective regulations.
QMS Implementation
Whether you need a tailored QMS built from the ground up or prefer to use existing QMS software, Rook Quality Systems ensures a seamless and efficient implementation. Our expert quality engineers handle setup, process integration, testing, and validation to ensure your QMS functions properly and meets all regulatory requirements.
QMS Gap Assessment
Struggling to enhance your QMS while maintaining regulatory compliance? Our quality engineers can conduct a comprehensive gap analysis to identify weaknesses and provide strategic solutions to bridge them. With our expert guidance, you can improve efficiency, strengthen compliance, and elevate overall quality performance.
QMS Management
Rook Quality Systems goes beyond initial QMS implementation—we bring over a decade of experience managing quality systems for medical device, SaMD, and IVD companies. Whether you need ongoing support for an existing QMS or are considering a RookQS-built system but lack the resources to manage it, our dedicated team of quality engineers ensures your QMS remains compliant, efficient, and continuously optimized.
The Value of RookQS QMS Support
- Experienced Quality Engineers – Partnering with RookQS grants you access to a team of skilled quality engineers, experts in QMS best practices. We ensure your system remains robust, compliant, and aligned with both your company's and customers' needs for the long term.
- Regulatory Expertise – Navigating the complexities of regulatory standards can be daunting. With a team of multiple Certified Quality Auditors, RookQS offers in-depth regulatory knowledge to keep your team informed, making QMS implementation smoother and more efficient.
- Streamlined Documentation – Say goodbye to the burden of QMS documentation. Our expert quality consultants craft efficient, long-lasting documentation that enhances productivity, aligns with FDA standards, and stands the test of time
