.png)
AUSTRAL Dx has obtained ISO 13485 certification as of April 17, 2026, marking a key milestone in the company’s development. The certification covers the design and development of contactless ultrasound imaging systems for the detection of pulmonary or cardiac diseases.
The certification was issued by GMED following a rigorous audit process covering the Paris and Meyreuil sites.
A strong commitment to quality
Obtaining this certification reflects AUSTRAL Dx’s commitment to structuring its operations in line with the requirements of the medical device industry.
It also demonstrates the teams’ commitment to implementing a robust quality management system ensuring the reliability, safety, and compliance of its technological developments.
A collective achievement
This achievement is the result of a collective effort led by Mathilde Hubert, QARA Director.
This milestone is fully aligned with AUSTRAL Dx’s development strategy to deliver innovative, high-performance solutions for cardiopulmonary diagnostics, serving both patients and healthcare professionals.
Want to help us transform emergency care?
Learn more about AUSTRAL Dx, our vision, and the technology behind our airborne ultrasound medical device.
What’s New
Explore our latest updates
