• Manufacturing Quality

Certifications

  • ISO 13485

  • ISO 9001:2015 with Design

  • AS9100:2016

  • FDA Compliant

  • GMP Compliant

  • UL Approved

Tools

  • OGP Optical Measuring System

  • Particle Counter to .5 to 5.0 Microns

  • Computrac Max 2000 Moisture analyzer

  • Mitutoyo optical comparator

  • Mitutoyo dial indicator

  • X-Rite spectro photometer

  • Data Color 400 Spectrophotometer

  • Brown & Sharp CMM

  • Tesa Hite Measuring System

  • Dynisco Melt Flow Index Tester

Support

  • Validation (PPAP, IQ OQ PQ)

  • Quality Manager

  • QA Staffing round the clock

  • Continuous QA Training

  • Custom Quality Plans to support your program requirements

  • Device History Record Management