A Cretex Medical company

Quality Systems

rms Company is committed to exceed our customers expectations in all aspects of its business. In keeping with this commitment, rms has developed and implemented a Quality Management System (QMS) that conforms to the exacting standards expected by today’s medical device industry. Our QMS assures the highest-quality products and services to meet your requirements by using advanced metrology and measurement techniques. Not only does this help ensure conformance with each specification but supports the continuous improvement process as well. Combine this with a robust training program and you can be assured that you are working with the highest skilled people in the industry, using the best technology available.

High-Level Project
Quality Support

  • Certified and registered QMS
  • Advanced Product Quality Planning (APQP)
  • Process Validations
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • Special processes
  • 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

Advanced Metrology
and Software

  • CMM’s
  • Keyence instant measurement system
  • Steinbichler blue light 3D scanner
  • Vision systems
    • SmartScope®
    • Micro-Vu
  • Precision contour measuring equipment
  • Profilometers
  • Statistical software packages include Mini-Tab® and Infinity QS®

Quality Policy

The Cretex Medical group of companies is committed to:

  • Achieving or exceeding customer expectations
  • Ensuring the effectiveness of the quality management system while complying with regulatory requirements
  • Empowering and developing employees
  • Fostering a culture of operational excellence and continual improvement

Certifications

 

FDA Registration as a Contract Manufacturer

Facility registration number: 2183946