ASE has a commitment to maintaining a quality system to achieve continuous improvement of products and services. All research and development is carried out according to quality design policies and procedures.
As an Australian manufacturer of in-vitro diagnostic devices (IVDs) we are proud to be a Therapeutic Goods Administration (TGA) Conformity Assessed company. We are certified to ISO 13485:2016 Medical Devices and have proven track record for manufacturing high quality products.
Therapeutic Goods Administration (TGA) Conformity Assessed
As an accredited manufacturer of In Vitro Diagnostic Medical Devices (IVDs), ASE is certified by the Therapeutic Goods Administration (TGA) — a part of the Australian Government Department of Health and Ageing.
ASE follows the code of Good Manufacturing Practice as outlined in the Therapeutic Goods Administration guidelines.
ISO 13485:2016 Medical Devices Certified
The ASE facility is fully certified to ISO 13485:2016 Medical Devices.
ISO 13485 complements the more commonly-known ISO 9001 standard, and provides a comprehensive quality management system for the design and manufacture of medical devices.