Quality Management System
AEHRC is committed to maintaining a suitable and effective Quality Management System (QMS) that meets international standards and regulatory requirements. Our QMS is certified to ISO 13485:2016, covering the “Design, development, manufacturing, installation and servicing of software-based medical devices”.
For approved collaborative projects involving software-based medical devices, AEHRC works closely with partners, leveraging our QMS to develop Technical File requirements that ensure compliance with both Australian and international regulatory standards including:
- Australian Therapeutic Goods (Medical Devices) Regulations 2002
- US Quality System Regulations 21 CFR 820
It’s important to note that AEHRC’s QMS is strictly used for collaborative partnerships and is not available for fee-for-service arrangements.
This certificate can be verified by visiting the BSI Client Directory online.
The Australian e-Health Research Centre (AEHRC) is CSIRO's digital health research program and a joint venture between CSIRO and the Queensland Government. The AEHRC works with state and federal health agencies, clinical research groups and health businesses around Australia.