Finished Device & Sub-Assembly

We have 60+ years of experience manufacturing complex subassemblies and finished devices. We can help with all your needs for single-use medical devices.

• Design for manufacturing (DFM)
• Complete engineering design and development
• Device subassembly
• Complete finished device assembly
• Sterilization management
• Sterile barrier packaging
• Regulatory-compliant labeling
• Vendor-managed inventory
• Dock-to-stock logistics
• Regulatory affairs management
• Enterprise quality management system
• Manufacturing transfers
• Scalability across a global footprint

We have decades of experience serving a range of markets by manufacturing a wide spectrum of finished devices and assemblies. Some examples include:

• Catheter-based delivery systems
• Steerable access catheters
• Balloon catheters
• Introducers, dilators & sheaths
• Orthopedic implants and instruments
• Implant delivery systems
• Gastrointestinal and urologic devices
• Fluid management tube sets

We are certified to industry standards to manufacture, assemble, and package medical devices and subassemblies in quality-controlled environments.

• 20+ ISO-certified Class 7, Class 8, and Class 100,000 cleanrooms
• Multiple portable or soft-walled controlled environments
• 1 million square feet of manufacturing operations