Our Vision

At Cellplex, our vision is to continuously improve patient outcomes through the supply of innovative niche medical technology.

Cellplex Quality System:

Cellplex Pty Ltd is a 100% Australian owned Company, with focus on perfusion technology, specialising in the design and manufacture of devices and equipment for cardiopulmonary care.

Cellplex Pty Ltd is committed to maintaining our status as the market leader in the cardiopulmonary surgical sector and to deliver high quality, innovative products that meet our customers’ expectations.

Cellplex Pty Ltd will deliver defect free products and services on schedule and on budget while maintaining commitment to the Therapeutic Goods Act 1989(2002) and all the applicable regulatory standards.

The Board of Directors formulates the Quality Policy to support the mission of Cellplex. The mission statement is reviewed annually as part of the quarter four planning process. From the mission statement the strategic objectives are developed, reviewed and periodically amended to ensure our mission and strategic objective will be achieved.

The system developed to comply with this policy is described in the Quality Manual. It is the responsibility of all staff to familiarise themselves with the contents of the quality manual and to comply with the policies and procedures described therein and with associated documentation at all times.

Copies of our Quality System certificates can be obtained on our website at the following locations:

ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services.

Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device complies with the Essential Principles.