Medical Device Team

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Medical Device Manufacturing

Our medical device team is focused on the full integration of the plastic molded part and other manufactured or purchased components, into a finally packaged and ready for used (sterile or non-sterile) medical device.  With our ISO 13485:2016 quality systems and our process validations we can ensure consistent produce quality and delivery.

Our capabilities include both ISO Class 8 assembly and injection molding capacity, not to mention other plastic joining and decorating technologies such as; radio frequency and ultrasonic welding, solvent and UV bonding and various decorating technologies.

Our Capabilities

  • ISO Class 8 clean room assembly
  • Controlled environment assembly
  • Turn key product transfers
  • New product development
  • Supply chain solutions
  • Various plastics joining and decorating technologies:
  • – RF welding
  • – Ultrasonic welding
  • – Solvent and UV bonding
  • – Pad, silk & foil printing
  • Various packaging solutions
  • Product testing
  • Full DOE, IQ/OQ and PQ validation
  • Vendor management and new source verification
  • Supply chain services