Our Quality Policy reflects the essential elements of our commitment to establish and maintain an effective, compliant Quality Management System.
We strive to provide the highest quality products that are adopted by surgeons, trusted by patients, and embraced by the healthcare community to improve outcomes and promote accessibility.
Ensuring our QMS
Ensuring our QMS remains effective, right sized and aligned with CytoVeris’ Mission Statement and strategy.
Complying with FDA
Complying with FDA Quality System Regulation (QSR) requirements and relevant statutes/regulations.
Challenging ourselves
Challenging ourselves to continuously improve the QMS through the review of quality objectives, while ensuring product safety and data accuracy remain primary focal points.
Encouraging QMS
Encouraging participation and promotion of QMS activities amongst all stakeholders through documented standards, on-going training/education, quality audits, and effective communication.
Maintaining a quality culture
Maintaining a quality culture with appropriate systems and processes in place to drive quality-focused behaviors to achieve and enhance Customer satisfaction.
Real-time imaging during prostatectomy could improve the odds of preservation of function and reduce recurrence for 90,000 men in the U.S. per year.
60% reduction in the breast cancer positive margin rate nationwide could avoid reoperations for 30,000 women annually.
Real-time bladder resection imaging could avoid 70,000 repeat TURBT procedures per year in the U.S.
Real-time imaging during prostatectomy could improve the odds of preservation of function and reduce recurrence for 90,000 men in the U.S. per year.
60% reduction in the breast cancer positive margin rate nationwide could avoid reoperations for 30,000 women annually.
Real-time bladder resection imaging could avoid 70,000 repeat TURBT procedures per year in the U.S.