TGA certificate AU Q00438 (Version 1.3) Issued 2021-10-26
27 October 2021
Conformity Assessment Certificate – Full Quality Assurance Procedures
For the Design and Manufacture of device categories listed on page 2 of this certificate.
This is to certify that the manufacturer’s quality management system complies with the relevant
provisions of Schedule 3, Part 1 (excluding clause 1.6) of the Therapeutic Goods (Medical Devices)
Regulations 2002. Certification is based on an assessment of the Full Quality Management System,
applied at each stage of medical device manufacture, from the design of a device until its final
inspection before being supplied.