SiSU Health is a certified Medical Device Manufacturer that builds medical device Stations in accordance with ISO 13485:2016 and Medical Device Directive 93/42/EEC Annex V in Europe. Within Australia, the SiSU Health Station has TGA Approval (ARTG: 317543).
SiSU Health complies with International Regulations and Standards, has rigorous calibration procedures 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 Data and Information Security complies with ISO 27001:2013 Information Security Management System 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:
- CE Mark
- ISO 13485:2016 Quality Management System for a Medical Device
- ISO 9001:2015 Quality Management System Requirements
- ISO 27001:2013 Information Security Management System Requirements
- ISO 45001:2018 OH&S Management System Requirements
SiSU Health Station received TGA Approval in May –ARTG Number 317543.