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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.

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DEVELOPMENT PROCESS

→  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
Driling
Pad Printing
Assembling; Packaging; Sterilization


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After the initial basic design phase, our R&D team has fully reviewed the initial prototype and help redevelop and industrialize this device to meet market requirements. 



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DEVELOPMENT PROCESS

→  PROJECT

Concept Pre-study
CAD Design
Rapid Prototyping
Material Selection
Design for Manufacture
Mold Manufacturing
Assembling Tools Manufacturing
FMEA Risk Analysis

→ OUTCOME

Design History File
IQ OQ PQ Validation Plan
Performance Validation
CE Mark – OBL Contract

  MANUFACTURING

Injection Molding
Ultrasonic Welding
100% Performance testing
Assembling
Packaging
Sterilization



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Promepla is a Contract Design Manufacturer for single-use plastic medical components and devices.

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