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Provide Medical Device Consulting and Regulatory Requirements Compliance Services

for ISO 13485, CE Mark and FDA Compliance for Medical Devices.

A GMP specialist will full medical device manufacturing and quality management expertise.  

 

Articles :  

 

1 : Knowledge and Experience

Possess knowledge of devices like Intravenous Administration/Blood sets, Endotreacheal, Feeding, Extension, Stomach and Suction tubing, Oxygen Mask, Cannula, Blood Transfer, Urine Bags and Intravenous Solutions operations. Also familiar with manufacturing of Entreal Feeding, CAPD, Colostomy Bags, Foley, Silicon, VPACE, Thermodilution Catheters, Medical Syringes, Scalp Veins, AVF, Intravenous Needles, Haemodialysis Arterial and Venous lines, Capillary Flow Dialysis or Hollow fibres.

Able to Recommend all types of Medical Plastics like PVC,TPE, Silicon, PC, ABS, Nylon, FEP, PTFE, PEEK, PEBAX etc. for Medical Devices and tubing manufacture.

Able to recommend Tip Forming, hole punching, Heat sealers, Ultrasonic sealers, Semi Automatic and Fully automatic machines for Catheters, Infusion therapy devices and different plastics medical devices manufacture.

 

2 : Places Visited and Skills acquired.

 V isited many Kendall facilities (Tyco) located at Tijuana-Mexico, Augusta-Georgia, Irvine-California in USA and Sabana Grande at Puerto Rico for on sites training on Plastic Extrusion, Blow Molding, Injection Molding of medical components and the assembly of Blood, Solution, Burette Administration sets for both adult and paediatric in 1989. On April 1993, I went to Vancouver, Washington USA, while working for Saliva Diagnostic Systems for on-site training on the testing of Saliva specimens from AIDS patients for HIV positive. I help this company to set up a manufacturing line for their Omni-SAL saliva collection devices. In Dec. 1993, went to Ohmeda plant in Tampa, Florida, USA to transfer a Central Venous Catheters manufacturing to Ohmeda Singapore plant.

Visited plants in both East and West coast of USA and various European countries for Pharmaceutical Films, Medical Plastics, Medical, Dip, various type of Tubing,  Rubber and plastics gaskets processing from 1997-2005.

A well trained Medical Device Plastics Engineer with more than 35 years of medical device manufacturing and also the Business Development Director for a US MNC  in the Asia Pacific Region. 

 

SEE THESE NEW INNOVATIVE DEVICES:

Article : 3 : MULTI-PURPOSE INFUSION PUMP

Article 4: INFUSION GUARD DEVICE

Article : 5 : FLUID WARMER

 Article : 6 : EZ FLUSH DEVICE


 

 

 

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993