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Assisted bronchial decongestion device

November 24, 2016

Our client, Physio-Assist has developed an innovative concept of equipment and tubing set dedicated to bronchial pathologies. We have acted as their product development and industrialization partner and have help drive the concept to fully operational equipment.

Physio-Assist:
A French innovative company search a partner for equipment and disposable device development.

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 Equipment Project:

  • Design for manufacture
  • Mold manufacturing
  • FMEA risk analysis

Disposable device Project:

  • Design for manufacture
  • Material selection
  • Mold and assembling tools manufacturing
  • FMEA risk analysis

Outcome:

  • Design History File
  • IQ OQ PQ validation plan
  • Performance validation

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CE Mark – OBL Contract

Equipment manufacturing:

  • Injection molding
  • Assembling, performance testing
  • Packaging

Disposable device manufacturing:

  • Injection molding
  • Ultrasonic welding
  • Assembling, packaging

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