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Pneumothorax decompression device

December 19, 2016

For our innovative client, we have reviewed and analyzed decompression devices on the market and redefined the market standard with new design and improved performance for end users.


Project:

 

  • CAD Design
  • Design for manufacture
  • Mold manufacturing
  • Assembling tools manufacturing
  • FMEA risk analysis

 

Outcome:

  • Design History File
  • IQ OQ PQ validation plan
  • CE Mark

Manufacturing:

  • Injection molding
  • Over-molding
  • Tip forming
  • Drilling
  • Pad printing
  • Assembling, packaging, sterilization

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Promepla, OEM Solutions for Single Use Medical Devices. Innovation accelerator in single use medical devices.

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