Quality

Our procurement team includes staff with medical and procurement backgrounds. As an organization, we will also undertake the sponsorship of products through the TGA, FDA, and EU to assist manufacturers when Medical Products Hub (MPH) acts as the Sponsor/Distributor or Distributor only.

A range of information is gathered on each product, generally 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 https://www.fda.gov/approval indicates that the medical device complies with the applicable USA regulations and enables the sale of products in America.
  • TGA: TGA https://www.tga.gov.au 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.
  • Where available, legal, credit & Government checks on suppliers.
  • SGS https://www.sgs.com/ independent inspection reports.

   

  To become a supplier with Medical Products Hub (MPH) you must first provide all relevant data (for each medical product) to be an authorized product and you must have the relevant approvals by the TGA, FDA, EU, or other relevant authority.