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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.  

First Article

Andrew See

 P ossess knowledge of devices like 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, Arterial Venous Fistula Needles, Intravenous Needles, Haemodialysis Arterial and Venous lines, Capillary Flow Dialysis or Hollow fibres.

 

Special skills in researching and analysing existing manufacturing procedures, developing and implementing improved methods and operations to work well with individuals of various cultures, languages and levels of training. 

 

Manufacturing and Quality Operations management expertise, which include development of production lines of major plastic medical devices, purchase, installation and maintenance of heavy equipment, inventory control, budget-preparation, administration, vendor selection and negotiations. Oversee all manufacturing operations to ensure the highest possible level of product quality. 

 

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993