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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.  

 

•  Headquartered in Ontario, Canada 
•  Three Offices in China : Hangzhou, Nanjing and Ningbo 
•  One Office in Turkey 

 

•  Business Include 
–  Consultation to Medical Device Manufacturers 
–  Medical Device Manufacturing Equipment, Materials and 
Components 
 
Laboratory 
–  Demo equipments from  HnG’s  principles 
–  Capability of a wide range of prototypes 
•  Service Center 
–  Full equipment with diagnostic, calibration and 
service equipment 
–  Fully trained personnel 
–  Provide services to customers in Asia pacific Area 
 
 
Equipments :  
  
l   AMERICAN KUHNE- Extruders 
l   VANTE - Tip Formers 
l   GLEBAR 
l   KINEFAC 
  MCS 
 
 
Materials 
l  ADVANSOURCE BIOMATERIALS 
l  HYDROMER 
l  MEMRY 
l  WYTECH 
 
Components 
  
l  Resonetics 
l  QOSINA 
l  SSF 
l  APOLLO 
l  ACME MONACO 
l  MOTION DYNAMICS 
MEIER TOOL 
VENTION Tubings, Balloons 
and Catheter - See www.vention.com  
 

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993