Compliance & Trust
Clear Path Toward
TGA SaMD Approval
EldrAIr has mapped a defined pathway to TGA Class IIb Software as a Medical Device (SaMD) approval, ensuring our technology meets the highest standards of safety and clinical validity. As our platform matures and large-scale research programs are completed, we will progressively advance through the certification process, building toward broader approvals that reflect the growing scope and impact of our products.”
Adherence to International Quality
and Risk Standards
ISO 13485:2016
Lays the foundation for our
Quality Management System
(QMS), aligned with medical
device regulations
ISO 27001
Ensures rigorous
information security and
protection of sensitive data.
ISO 14971
Under development for methodical
risk management across EldrAIr’s
lifecycle, particularly critical for AI-
driven SaMD
Secure, Sovereign Data Practices
All voice data is encrypted, de-identified, and stored on secure Australian serversensuring local data sovereignty and compliance with Australian privacy standards.