Regulatory & Quality

Quality Impacts Lives

We are committed to meeting and exceeding our customers’ expectations and regulatory requirements throughout our organization. Our Quality Management System (QMS) has been developed to conform to the exacting standards of today’s medical device industry. Our robust QMS is backed by a team of dedicated and highly trained quality professionals, who will assure conformity to every specification by employing our advanced metrology systems and measurement techniques to provide you with the highest-quality products and services in the medical device industry.

Quality Engineering

  • 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

  • Coordinate Measurement Machines (CMMs)
  • Vision systems
    • Keyence instant measurement system
    • Micro-Vu
  • 3D Scanning
    • CT scanner
    • Zygo scanner
    • Alicona scanner
  • Precision contour measuring equipment
  • Profilometers
  • SEM analyzer
  • Industry-leading statistical software

Quality Policy

We are 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

Facility Certifications

Coon Rapids, Minnesota

Anoka, Minnesota