A Cretex Medical company

Quality Systems

Quality systems that meet and exceed standards.

rms Surgical has developed and implemented a Quality Management System (QMS) that conforms to the rigorous requirements demanded by today’s medical device industry. The QMS focuses on providing products and services that meet your requirements by ensuring conformance to each and every specification, offering continuous process improvements and delivering robust training programs — so you can be confident you’re working with the highest skilled manufacturers in the industry.

High-Level Project
Quality Support

  • Advanced Product Quality Planning (APQP)
  • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
  • Production Part Approval Process (PPAP)
  • Process Failure, Modes, and Effects Analysis (PFMEA)
  • Gauge Repeatability and Reproducibility (GR&R)
  • Capability analysis
  • Statistical support for validation planning and execution

State-of-the-art
Quality Lab

  • Coordinate Measuring Machines
  • Vision systems
  • Precision contour measuring equipment
  • Profilometers
  • Statistical software packages include Mini-Tab and QC Calc Real-time

Quality Policy

  • Achieving or exceeding customer expectations
  • Ensuring the effectiveness and compliance with all requirements of the quality management system
  • Empowering and developing employees
  • Fostering a culture of operational excellence and continuous improvement

Certified and Registered QMS

certification

FDA Registration as a Contract Manufacturer

  • rms Surgical, Anoka, Minn., facility registration number: 3010009693
  • rms Surgical, Memphis, Tenn., facility registration number: 3003661352