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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.  

Second Article: 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.

In 1998-2005 visited Belfast, N. Ireland, Belgium and Italy, various plants in New Jersey, USA  for on site training on Pharmaceutical Packaging, Medical Plastics, PVC Resins, Aerosol and Comestics Packaging.  

A well trained Medical Device Plastics Engineer with more than 25 years of medical device manufacturing and Regional Business Development Director experience for the Asia Pacific Region for a MNC to cover Pharmaceutical, Medical, Food, Comestics, Aerosol, Paints and coatings industries.

 

 

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993