Compliance
ISO13485 Quality Management System
You can rest assured that all products supplied by Andent are manufactured under a Quality Management System (QMS) which is certified under ISO13485 Medical Devices. This is the gold standard for the manufacture of Medical Devices.
Our QMS raises the standard of how we manufacture dental medical devices for you, the dentist. It ensures that we have clear and robust processes for material selection, equipment maintenance, staff training, and rigorous quality control.
Importantly, is means that for every medical device that we make for you, we can trace the materials and components used, and be confident in providing you with a high quality restoration.
Our QMS also includes customer feedback loops, so you can be confident that when you provide us with comments, we learn from that and feed that back to improve future production.
The QMS is audited by a third party notified body on an annual basis, and you can view are current audit certificate here.
- Stage 1 – Complete
The TGA has been notified of all patient matched medical devices that we produce, as part of the transition phase.
All cases are manufactured on instruction from an authorised health professional, using materials that are listed on the ARTG
All the products of Andent are manufactured under a Quality Management System, certified under ISO1385 Medical Devices by a third party notified body.
- Stage 2 – In Progress
Prior to the transition phase ending in November 2024, we will list certain patient matched medical devices directly on to the ARTG.
