Quality & Compliance

 

Compliant to International Standards

 

SiSU Health Group is the medical device manufacturer of the SiSU Health Station, which is a class IIa medical device entered onto the ARTG (317543).

 

Our quality management system is ISO 13485:2016 certified.

 

SiSU Health complies with international regulations and standards and maintains high-quality procedures. Each SiSU Health Station is manufactured in our Melbourne facility with the final quality assurance inspection completed by our trained Melbourne team prior to product dispatch.

 

Servicing is conducted by SiSU Health employees to ensure the highest quality customer service is provided with yearly refresher training conducted.

 

Our information security management system complies with ISO 27001:2013 and we have globally aligned with GDPR (General Data Protection Regulation). All data is encrypted to ensure we manage personal and sensitive biometric information with absolute reverence and country specific legal compliance.

 

Customer trust is at the heart of SiSU Health and we strive to be completely transparent with our business practices. To view any of our ISO Certificates, please select the appropriate one below: