Imaxeon Quality Management

Our Quality Management system and manufacturing competence is an integral part of our company culture. Key milestones in our quality systems development include:

• 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 quality assurance auditor BSI and the TGA to design, manufacture, and service a range of Class IIA and IIB medical devices, including power contrast Injectors and associated consumables. Imaxeon undergoes an annual audit to ensure all quality processes are of the highest standard and ISO certifications are maintained.