For Sale - CS - 382
Specification
Reference Number
CS - 382Location
IndiaProduct Details
Medical Device Manufacturing and Validation Consultants
20+ years of Worldwide experience in Disposable Plastic Medical Device Manufacturing Industry
Services Provided:
Developing products from Concept ideas
Product designing
CNC Prototyping
3D Printing
Mold design (DFM)
Mold making
Plastic Injection molding
Insert molding
LSR (Liquid Silicone Rubber) molding
Metal Injection Molding (MIM)
Ultrasonic Welding Assembly
Medical Device Validation per GMP Guidelines which includes:
Validation of all Equipment's used for manufacturing
Molding machines
Molds and auxiliary equipment's
Molding Processes
Plastic components/parts produced
Proficient in Creating Validation Protocols, Reports and Data Analysis for:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Inventor of two US Patents for a Cancer drug delivery device:
I) US Patent # 8382724
II) US Patent # 9474888
The invention replaced a metal component with plastic; saving millions of Dollars in raw material cost for manufacturing the medical device
Producing plastic component was super-fast compared to metal component which saved production time of 3 weeks amounting to millions of dollars of savings in labor and assembly cost of the medical device
The invention helped create an all plastic medical device, providing millions of dollars in opportunity cost and hence sales increase
Product experience
1) Cancer drug delivery devices:
Ports
PICC’s (Peripherally Introduced Chronic Catheter)
2)Dialysis Catheters
3) Introducers
4) Insulin Pens
5) Feeding Tubes
6) Drainage Catheters
7) Disposable Centrifuges
8) Blood Transfusion Catheters
9) Bio-absorbable screws and staples
10) Actuators and Caps
Expertise offered
Create Medical devices from Concept ideas
Prototyping and design change iterations till design is frozen
Mold design DFM (Design for Manufacturability)
Create a Robust Injection molding process per RAM principles
Manufacturing and Validation of Equipment's/Medical Device/ Components per GMP Guidelines
Performing Assembly Validation of Medical Device Components per GMP Guidelines
Manufacturing Medical devices in Class 10,000 & Class 100,000 Clean room environment
Processing Experience with PP, GPPS, HIPS, HDPE, ABS, PMMA, PC, SAN, K-Resin, Nylon (PA), Delrin (POM), TPE (Thermoplastic Elastomer) and Liquid Silicone Rubber (LSR)
20+ years of Worldwide experience in Disposable Plastic Medical Device Manufacturing Industry
Services Provided:
Developing products from Concept ideas
Product designing
CNC Prototyping
3D Printing
Mold design (DFM)
Mold making
Plastic Injection molding
Insert molding
LSR (Liquid Silicone Rubber) molding
Metal Injection Molding (MIM)
Ultrasonic Welding Assembly
Medical Device Validation per GMP Guidelines which includes:
Validation of all Equipment's used for manufacturing
Molding machines
Molds and auxiliary equipment's
Molding Processes
Plastic components/parts produced
Proficient in Creating Validation Protocols, Reports and Data Analysis for:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Inventor of two US Patents for a Cancer drug delivery device:
I) US Patent # 8382724
II) US Patent # 9474888
The invention replaced a metal component with plastic; saving millions of Dollars in raw material cost for manufacturing the medical device
Producing plastic component was super-fast compared to metal component which saved production time of 3 weeks amounting to millions of dollars of savings in labor and assembly cost of the medical device
The invention helped create an all plastic medical device, providing millions of dollars in opportunity cost and hence sales increase
Product experience
1) Cancer drug delivery devices:
Ports
PICC’s (Peripherally Introduced Chronic Catheter)
2)Dialysis Catheters
3) Introducers
4) Insulin Pens
5) Feeding Tubes
6) Drainage Catheters
7) Disposable Centrifuges
8) Blood Transfusion Catheters
9) Bio-absorbable screws and staples
10) Actuators and Caps
Expertise offered
Create Medical devices from Concept ideas
Prototyping and design change iterations till design is frozen
Mold design DFM (Design for Manufacturability)
Create a Robust Injection molding process per RAM principles
Manufacturing and Validation of Equipment's/Medical Device/ Components per GMP Guidelines
Performing Assembly Validation of Medical Device Components per GMP Guidelines
Manufacturing Medical devices in Class 10,000 & Class 100,000 Clean room environment
Processing Experience with PP, GPPS, HIPS, HDPE, ABS, PMMA, PC, SAN, K-Resin, Nylon (PA), Delrin (POM), TPE (Thermoplastic Elastomer) and Liquid Silicone Rubber (LSR)
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