Quality and Compliance

Ensuring Compliance and Maintaining High Standards of Quality

SiSU Health Group (SiSU Wellness Pty, Australia) is the medical device manufacturer and Supplier of the class IIa medical device, SiSU Health Station.

SiSU Health Group complies with international regulations and standards and maintains high-quality procedures with the quality management system, ISO 13485:2016 certified.

The SiSU Health Station is registered with the ARTG in Australia, the MHRA and has CE 698848.

SiSU Health UK is designated as the exclusive UK responsible person acting for the manufacture. All UK maintenance is conducted by SiSU Health employees to ensure the highest quality servicing and operation.

The SiSU Health information security management system complies with ISO 27001:2013 and is GDPR compliant.

Customer trust is at the heart of SiSU Health and we strive to be completely transparent with our business practices.

To view the regulatory Certificates, please follow the link below.