Device Assembly<br>Case Study

Device Assembly
Case Study

  • Women’s Health Device Market Leader
  • Line Transfer Completed On Schedule in 9 months
  • 28 components
  • 11 suppliers
  • 6 Finished Goods Produced
  • 12 Operators per Shift, 12 Operational stations
  • 2 Shifts running 24/4
  • 23 pieces of equipment installed (RF Tipper, Laser Balloon Sealing, Balloon Molding, Corona Treatment)
  • 30 Work Instructions, 1 MOP and 1 QOP.
  • IQ, OQ, PQ – 31 protocols and 31 completion reports
  • Sterilization (Gamma) Managed
  • 80%+ Reduction in Labor/Overhead Cost

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Medical Device Assembly part