Imaxeon Quality Management

Our Quality Management system and manufacturing competence is an integral part of our company culture and a brief history of our quality records is:

  • ISO 9002 in October 1994,
  • ISO 9001-2000 in November 2002
  • 93/42/EEC (CE Mark) Full Quality Assurance System in March 2005
  • ISO 13485:2003 in March 2005,
  • TGA Conformity Approval in February 2006

Imaxeon Pty Ltd is accredited by TUV and TGA to design, manufacture, and service a range of Class IIA and IIB medical devices, including power contrast Injectors and associated consumables.

 Download Imaxeon 93/42/EC MDD Certificate

 

 Download Imaxeon ISO13485:2003 Certificate

 

 Download Imaxeon TGA Conformity Assessment Certificate