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.