QUALITY

Isometric Micro Molding is committed to meeting or exceeding customer expectations through continual improvement of our processes, resulting in enhanced product quality, optimal support, and on-time delivery. This commitment is achieved by the dedication of all our employees, and the pride taken in the performance of their duties. When this is coupled with our company-wide commitment to comply with the requirements of — and to maintain the effectiveness of — our quality management system, it explains why we are successful in the complex and exacting projects we undertake with our medical device and drug delivery device customers.

ISO 13485 Certification

EQUIPMENT/PROCESS CAPABILITY

  • Uninterrupted R&D and molding
  • Experience with exotic/challenging resins
  • PEEK, PLA, TPU, PES, LCP, PP, PE, COC
  • Nitrogen-infused resin systems
  • Statistcal process control and monitoring
  • 6 axis robotics and automation for part handling and quality

ENVIRONMENT

  • 3,000 sq. ft Class 7 production cleanroom
  • Class 7 development cleanroom
  • Separated positive psi gowning areas
  • Climate and humidity controlled metrology lab
  • Electrostatic and biocompatible cleanroom flooring and walls

VALIDATION

  • Capability Studies/DOE/Gage R&R
  • IQ/OQ/PQ validation
  • CT Scanning to 0.1 um resolution
  • Vision/Laser CMM system
  • Each production machine equipped with high power microscopes