ISO 13485 Registered

Contract Manufacturing

Stellartech offers turnkey manufacturing services for disposable sterile devices and electronic instruments. Our experience in the transfer of complex medical devices allows us to scale up production for you smoothly and efficiently. We offer complete manufacturing support including supply chain infrastructure, excellent supplier relationships and a highly trained staff of manufacturing engineers. Throughout the manufacturing cycle we seek opportunities for continuous improvement to shorten cycle time, improve reliability and reduce costs. The result is on-time delivery of products of the highest quality that help you compete more effectively in your marketplace.

Our capabilities include:

  • Manufacture of Class II and Class III devices
  • FDA registered, California licensed, ISO 13485:2012 certified manufacturing facility
  • Controlled environment for manufacture of catheters, surgical tools and other sterile devices
  • Electronics manufacturing area for fabrication, product assembly, final test and packaging
  • Excellent supplier relationships and skill at sourcing components and raw materials
  • In-house MRP system to support scheduling and materials management
  • Rigorous document control for strict compliance and traceability
  • Up-to-date manufacturing methods and procedures
  • PCB inspection and testing
  • Staff of skilled manufacturing and quality engineers
  • Complete post-production service capability

 

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