Every aspect of our operations is guided by a set of processes and procedures that represent man-decades of accumulated knowledge and expertise.

These rigorous procedures are embodied in our Quality Management System (QMS), that is at the heart of our Quality Program.

Our Quality Management System

Our Quality Management System has been developed and implemented to meet the requirements of both:

  • ISO 9001:2015 - QMS for organisations providing products and services that must meet customer and applicable statutory and regulatory requirements.
  • ISO 13485:2016 - QMS for organisations providing Medical Devices and Software.

Continual Process Improvements

Implemented in June 2021, our QMS has undergone two major internal audits and reviews since January 2022.

These have resulted in improvements to our operational procedures and the QMS itself, with our team working towards our first independent audit in Q3 2022.

If you'd like to learn more about our Quality Program, get in touch.