A Cretex Medical company

Quality Systems

Spectralytics is 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 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.

High-Level Project Quality Support

  • Certified and registered QMS
  • Process validations
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • Special processes
    • Statistical analysis
  • Machine and critical software validations
  • First Article Inspection (FAI)
  • Process Failure, Modes and Effects Analysis (PFMEA)
  • Root Cause Analysis (RCA)
  • Gauge Repeatability and Reproducibility (GR&R)
  • Capability analysis

Advanced Metrology and Software

  • Tensile and elongation testers (Lloyd Instruments & Mark-10)
  • Laser micrometers (Mitutoyo/Keyence)
  • Vision systems
    • SmartScope® (OGP MVP/Flash & RAM Starlite/Sprint)
    • Visicon Sierra
    • Visicon FS-85
    • Nikon (VMR-3020)
  • Digital Video Linear Measurement systems (DVLMS)
  • Statistical software packages include Mini-Tab® and QC-Calc®

Quality Policy

  • Achieving or exceeding customer expectations
  • Ensuring the effectiveness and compliance with all requirements of the Quality Management System (QMS)
  • Empowering and developing employees
  • Fostering a culture of operational excellence and continuous improvement

Certifications

• EN ISO 13485 View/Download