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Medical Device Manufacturing

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 final 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.

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