Quality Policy
Last Updated: July 2026
SiSU Health is committed to developing medical devices and digital health technologies with a customer and client-centric focus. With safety, performance and reliability at the forefront, we are committed to designing, developing, manufacturing and maintaining medical devices that meet the applicable requirements of ISO 13485:2016.
We achieve this by maintaining a robust Quality Management System that ensures the consistency and continuous improvement of our devices, health solutions and business processes. SiSU Health relies on documented processes and procedures that ensure the consistency and traceability of our products and services. We also uphold these high standards for our employees, ensuring they possess the necessary skills and knowledge by providing organisation-wide competency and awareness training.
SiSU Health ensures that its products and services are upheld to a high standard by following a risk-based approach. Whereby, any risks to the safety and quality of our products and services are systematically identified, assessed, and mitigated. SiSU Health also employs this risk-based approach within our supply chains by ensuring that our suppliers are effectively selected, monitored and evaluated SiSU Health is committed to meeting the requirements of all applicable regulatory frameworks, namely:
- Australian Therapeutic Goods (Medical Devices) Regulations 2002
- European Medical Device Directive (MDD) 93/42/EEC & 2007/47/EC
- European Medical Device Regulation (MDR) 2017/745
- UK Medical Device Regulations (UK MDR) 2002
SiSU Health’s executive team is committed to implementing, maintaining, communicating and ensuring understanding of the importance of the Quality Management System and its processes. This Quality Policy provides a framework for establishing, reviewing and monitoring the quality objectives of the organisation, ensuring they are communicated, understood and implemented throughout the organisation.
In the spirit of reconciliation, we acknowledge the Traditional Custodians of Country throughout Australia. We recognise their continuing connection to land, sea and community and we pay our respects to Elders past, present and emerging. SiSU Health is dedicated to supporting better health and health outcomes for indigenous peoples across Australia. As of May 2025, we are proud to have provided more than 69,000 free health checks to more than 54,900 individuals of Aboriginal and Torres Strait Islander heritage across Australia.
^DISCLAIMER: The use of SiSU Health Products is not intended to replace medical advice from a qualified physician or healthcare professional. Always check with a qualified healthcare professional before making any changes to your health or lifestyle.
A Wesfarmers Company
Company
Office: L8, 637 Flinders Street, Docklands, VIC 3008
Manufacturing: 15 Islington Street, Collingwood, VIC 3066
(03) 9818 3998
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