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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.  

List Of Services provided:

By Andrew See 

  1. Introduce Promising Medical companies in China or the region that has consideration for Joint Venture, Merger or Acquisition.  
  2. Provide Market Information for all different kinds of medical Devices including the Medical Plastics in the Asia Pacific Region, Middle East and also USA and Europe.  
  3. Assist in Material Selection, recommending of testing laboratory and final approval of the products recommended.  
  4. Assist Companies in the setup of Medical Products Production Processes and Lines. Including equipment recommendation, procurement and assist in installation of Plastics Processing machineries which include Extruders, Blow Molding and Injection Molding Machines. Thermoforming, Form, Fill and Seal packaging machines.  
  5. Seek and Solicit Plastics tooling: - Example: Injection Molds and Extrusion Dies.  
  6. Experienced in Ultrasonic, High Frequency, Induction Heating and Solvent Sealing of medical components.  
  7. Recommend plastics compounds or resins for medical components. I know most of the Plastics Resins suppliers in the Asian Pacific Region.  
  8. Setting up of Production lines and qualify processes for any type of Plastics Medical Devices of Packaging Pouches.  
  9. Familiar with Steam, Ethylene Oxide and Gamma Sterilization including Sterility Validation and Residues Testing requirements.  
  10. A Good Manufacturing Practices specialist that have worked with Q.A. Managers and Directors to set up Quality Systems with documentation in accordance to ISO 9000, ISO13485 and cGMP requirements.  
  11. Familiar with Chinese (CFDA), Australian (TGA), German (TUV), U.K. (MHRA), Japan(MHLW & PMDA), U.S.A. (FDA) guidelines and Code of Federal Regulations. These are major health organizations governing healthcare and drugs regulations in the World. Help companies in obtaining ISO9001, EN46000 and ISO13485 standards,  
  12. Familiar with all chemical and biological testing in accordance to EP 3.1.2, ISO 10993 and USP Class VI for medical devices and including all toxicology studies.    
  13. Ability to conduct audits on Plant Manufacturing Facilities to ensure G.M.P. compliance with recommendations to comply with the relevant authorities.  
  14. Assistance can be provided for soliciting new vendors and qualifying new materials.  
  15. Wide range of International contacts stretches from East to West. Major countries include China, Singapore, Malaysia, Thailand, Taiwan, Korea, Japan, Australia, Pakistan, India, Germany, Belgium, Italy, England, Indonesia, Middle-East countries and U.S.A.  
  16. Familiar with Physical, Chemical and Microbiological testing required by medical devices upon release for distribution.  
  17. Recommend purchase and help in installation of automation equipments for the manufacturing of Medical Devices.  

 

With its wide regional experience, we can also offer special consultancy services in the area of manufacturing process improvements. These can be related to productivity improvements, yield improvements, and product development improvements, and also business process improvement if engaged.

 

ISO9001

ISO 13485

CE Mark

FDA Requirements

EP Testing

Class VI

ISO 10993