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Quality

Our procurement team includes staff with medical and business backgrounds.
A range of information is gathered where appropriate, including:
  • ISO: ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
  • CE: CE Marking indicates that your medical device complies with the applicable EU regulations and enables the sale of products in 32 European countries.
  • FDA: FDA approval indicates that the medical device complies with the applicable USA regulations and enables the sale of products in America.
  • TGA: TGA approval indicates that the medical device complies with the applicable Australian regulations and enables the sale of products in Australia.
  • Our review process considers Anti-Slavery and exploitation laws.
  • Test Reports and verification of documentation presented.
  • Legal, credit & Government checks on suppliers.
  • SGS independent inspections reports are also obtained.