QUALITY

We maintain strict quality standards for customers in several industries. 

  • ISO 13485 Certified (click to view)
  • 21 CFR Part 820
  • Process Validations: IQ-OQ-PQ
  • "White Room" molding (consistently measures to ISO Class 8 levels)
  • Class 8 and 7, (Formerly Class 100,000, 10,000) clean room molding
  • ISO Class 6, (Formerly Class 1,000) assembly clean room
  • SPC monitoring and printing press side
  • ROI Ram Optical Video - OMIS *** inspection system
  • Latex and DEHP free manufacturing facility
  • cGMP