Melbourne, Australia – 13 November 2014 – Nurse call and workflow solutions provider
Austco Communication Systems Pty Ltd, a wholly owned subsidiary of Azure Healthcare Ltd (ASX:AZV), today announced that the Australian Therapeutic Goods Administration (TGA) has approved its products for inclusion on the Australian Register of Therapeutic Goods (ARTG).
This inclusion marks Austco as the first nurse call and workflow solution supplier of its kind to have its products formally approved for supply in Australia by the TGA. Approval for inclusion into the ARTG register means that Austco’s products meet acceptable standards of quality, safety and efficacy in accordance with the Therapeutic Goods Act. For a medical device to be included in the ARTG, the TGA must be satisfied that evidence exists appropriate to the perceived risks of the device to support its safe and effective use, and that an appropriate system is in place for monitoring the ongoing performance and safety of the device.
“We believe our customers and their patients deserve the best,” stated Robert Grey, CEO and Chairman of Austco. “Although our current products were exempt from the need to be included in the ARTG, we felt that that it was important to register and show that as an organisation we care enough to strive for the highest level of integrity and excellence for our customers, and more importantly that we are willing to put ourselves up for scrutiny to prove this.”
This latest achievement from Austco makes it the only nurse call and workflow solutions supplier in the world to be registered for TGA, FDA (US Food and Drug Administration) and accredited for UL-1069 (North American standard for “Hospital Signalling and Nurse Call Equipment”).
“We are very proud to be the only company in our market sector to be accredited for UL-1069 and registered with the FDA and TGA. Going through the process challenged us to find better ways to serve our customers, and it is a constant reminder that our responsibility is to continuously improve not only for our customers, but also for the people to whom they have a duty of care. ” Concludes Mr Grey.
For further information contact: Robert Grey – Chief Executive Officer
Tel: +61 3 9209 9688 or email email@example.com