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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.  

Experience of Andrew See: 

 

9 years of successful Regional Business Development and Country Agents management for Food, Medical and Pharmaceutical Packaging Materials and 16 years of successful Production/Manufacturing management experience with 2 years in Research and Development, 2 year in consultation of different types of Plastics Medical Devices with 6 years in Quality Assurance. A total of 35 years in Medical Devices/Food and Pharmaceutical industries.

 

Work with engineers from various countries, R & D departments to plan, build and operate industrial facilities. Direct and co-ordinate all phases of manufacturing activities in clean rooms of Class 10,000 to 100,000 from Incoming Raw Materials Inspection to Sterilization, Final Inspection and Distribution. At the same time ensure maximum efficiency of operations and optimal utilisation of resources

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993