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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.  

Contact Us:

 

Medipro Consultancy and Services  

Contact Name:

Andrew See
 

Contact Telephone: 65 92331886
 
Address:

669A, Jurong West Street
64,  #04-96
Singapore 641669

E-Mail:

andrsee@singnet.com.sg
 Skype:  andrsee60


 

 Services Provided:

  • Provide Regulatory Affairs consultancy and assistance for registering Class I,II and III or A,B,C and D Medical Devices or IVDD devices with the Asian Regulatory Bodies.
  • Provide training on ISO 13485, ISO14971, ISO10993,  CE Mark - MDR, IVDR and 21CFR820. 
  • Provide consultancy in Medical Devices Manufacturing and Pharmaceutical Packaging Solutions  
  • Cleanroom installation, moulding operations for medical components manufacture.    
  • Recommend Medical Rubber, Plastics and Silicon Medical components for Medical and Pharmaceutical applications. 
  • Recommend, solicit and source for Medical Plastics, Medical & Pharmaceutical Packaging  
  • Introduce and recommend Manufacturing Machineries and Automation Equipment for components Assemblies and micro devices  
  • Training in Medical Tubing Extrusion and Extrusion Equipment recommendations.   
  • Recommend Tip Forming, Hole Punching, Heat Sealing equipment for medical devices manufacturing  
  • Recommend Companies for OEM and ODM Manufacturing with guided Solutions and Suggestions  
  • Introduce Promising Medical/Pharmaceutical companies in China/ASEAN to any Asian  or Foreign Enterprises for Joint Venture, Merger or Acquisition.  
  • Assist companies to look for promising companies for Joint Venture or Joint co-operation in different medical fields. 
  • Seek and help to co-develop markets for new medical, food and pharmaceutical products    

 

 

 

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993