Medical Device Assembly, Kitting and Packaging

Paradyne Medical provides ISO Class 7 cleanroom and non-cleanroom 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. We support medical device companies at every stage, from venture-backed start-ups developing their first implant to established OEMs scaling validated production. Past programs include: Disposable dialysis tubing sets, cardiac catheters, electro-mechanical devices, orthopedic equipment, surgical implants, respiratory devices and others.
Paradyne Medical’s quality system and processes support 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