Quality Certificates

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 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.

ASE Online
Australian Scientific Enterprise

ISO 13485 Certified

The ASE facility is fully certified to ISO 13485:2003.

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.