Case Studies Archives

Thanks to our unique manufacturing expertise, our R&D team has helped our client, a contract manufacturer, to review and improve a critical production process manufacturing equipment.
This has resulted in improved capabilities and quality of products delivered.

https://www.promepla.com/wp-content/uploads/2016/11/case-5-pict-PROMEPLA-Driller-1.jpg

DEVELOPMENT PROCESS

→ PROJECT

Manufacturing Process Analysis
Mechanical CAD Design
Industrial Automatism Software Development
Equipment Manufacturing
FMEA Risk Analysis

→ OUTCOME

Design History File
IQ OQ PQ Validation Plan
CE Mark

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.

https://www.promepla.com/wp-content/uploads/2016/11/case-2-pict-Physio-Assit-1.jpg

https://www.promepla.com/wp-content/uploads/2016/11/case-2-pict-Physio-Assit-2.jpg

DEVELOPMENT PROCESS

→ 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
CE Mark – OBL Contract

→ MANUFACTURING

Injection Molding
Ultrasonic Welding
Assembling; Packaging

After industrialization of an initial version of the device, our R&D team has fully redesigned the new version based on competitive review of functionalities. In addition, we have co-developed and co-patented part of the product.

https://www.promepla.com/wp-content/uploads/2016/11/Case-1-pict-AMT-saflo90-2.jpg

https://www.promepla.com/wp-content/uploads/2016/11/case-1-pict-AMT-Saflo-90-1.jpg

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
CE Mark

→ MANUFACTURING

Injection Molding
FEP Tip Forming
Assembling
Packaging
Sterilization

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.

https://www.promepla.com/wp-content/uploads/2018/09/Pneumofix.jpg

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

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.

https://www.promepla.com/wp-content/uploads/2018/09/Auxin-Surgery.jpg

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

CLASSIC LIST

Medical devices production process manufacturing equipment

Assisted bronchial decongestion device

Dedicated subcutaneous administration device with secure needle protector

Pneumothorax Decompression Device

Manual micro dosing device for non-invasive surgery

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Medical devices production process manufacturing equipment

Assisted bronchial decongestion device

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