Medical Device Assembly, Kitting and Packaging

Paradyne Medical provides Clean Room and Non-Clean Room assembly, kitting and packaging of medical devices. Our Quality System has been developed by our management team with over 50 years of medical device quality experience and is ISO 13485 compliant.  Customer-specific assembly procedures are developed and executed by highly trained technicians on validated equipment. Existing clients range from emerging to Fortune 500 companies and include: Disposable dialysis tubing sets, cardiac catheters, electro-mechanical devices, orthopedic equipment, surgical implants, respiratory devices and others.
Paradyne Medical efficient quality system and innovative processes provide faster speed to market for small clinical, test and market trials through full production lots.

Packaging, Kitting and Assembly expertise:

  • Complete Project Management
  • Product Development
  • Regulatory Submissions and Consulting
  • Manufacturing
  • Catheter and Tubing Set Assembly (flaring, stretching)
  • Electro-Mechanical Device Assembly
  • Solvent Bonding
  • UV Bonding
  • Ultrasonic Welding
  • RF Welding
  • Kit Assembly (Kitting)
  • Hand Assembly
  • Packaging Engineering
  • Packaging
  • Impulse Pouch Sealing
  • Medical Tray Sealing
  • Sterilization Coordination
  • Supplier Approval, Audit and Material Sourcing
  • Lot/Batch/Serialized product management