MANUFACTURING CAPABILITIES

Finished Device
Assembly & Packaging

Resonetics will help streamline your supply chain through our finished assembly and packaging services.

Resonetics understands the need to have a single, strategic partner for a complete manufacturing solution. Our FDA registered facility in Israel offers ISO Class 7 cleanroom assembly and packaging. We produce many components, implants and sub-assemblies in-house and have extensive sourcing capabilities so that you can rely upon a single supplier. This will help you reduce cost, improve lead times and mitigate risk.

When you need a manufacturing partner to support limited volumes for catheter design verification and validation, clinical trials or early production, we offer pilot manufacturing for catheter delivery systems from our Westborough, MA facility (Boston). This option can flex to the dynamic demands of your development program. As commercial needs grow, we can scale assembly at another Resonetics facility in the U.S. or abroad.

 

FINISHED DEVICE ASSEMBLY

  • ISO Class 7 controlled environment (Class 10,000)
  • Part washing and cleaning
  • Manual and automated complex assemblies
  • Laser welding in a controlled environment
  • QA support and process validation

PACKAGING

  • Assistance with packaging design
  • Sterile packaging
  • Kitting
  • Supply chain management
  • Pouch seal validation
  • Sterilization management
  • Storage in a controlled environment
  • Shipments to end customers
 
 

PILOT MANUFACTURING FOR CATHETER DELIVERY SYSTEMS

  • Laser welding
  • Adhesive bonding
  • Shaft lamination and complex catheter reflow
  • Tipping stations and secondary operations such as skiving and hole punching
  • UV curing
  • Pull wire attachment
  • Shaft termination
  • Handle attachment
  • Hub integration