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

At the beginning of every new project, we work together with our customers to assure that quality is built into the products in the design stages. We accomplish this through our Stage Gate process with deliverables that include:

  • Advanced Product Quality Planning (APQP)
  • Failure Mode and Effects Analysis (FMEA)
  • Statistical Process Control (SPC)
  • Measurements System Analysis (MSA)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Production Qualification (PQ)

We ensure that our processes have the documentation and traceability to meet the current medical device industry standards and practices.

Advanced Metrology and Software

  • Tensile and elongation testers (Lloyd Instruments & Mark-10)
  • Laser micrometers (Mitutoyo/Keyence)
  • Vision systems
    • SmartScope® (OGP Quest & Flash)
    • Visicon Sierra
    • Visicon FS-85
  • Digital Video Linear Measurement systems (DVLMS)
  • XRF testing of incoming raw materials
  • Zeiss Prismo Ultra CMM

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

Brooklyn Park, Minnesota

Dassel, Minnesota

Soquel, California

  • EN ISO 13485:2016 (Component and Device Technologies, Inc.)
  • FDA Registration as a Contract Manufacturer
  • State of California Department of Public Health and Food and Drug Branch – Device Manufacturing License #59603