Cylite obtains ISO 13485 Certification

Cylite receives ISO 13485 Certification

Melbourne, 8 March 2020 – Cylite Pty Ltd is pleased to announce that it has been awarded International Organization for Standardisation (ISO) 13485:2016 certification for medical device quality management systems (QMS) following review by BSI. ISO 13485:2016 is an internationally recognised quality standard specific to the medical device industry.

ISO 13485 certification affirms to Cylite’s patients and partners that the company is providing the best quality management systems and regulatory compliance for its 4th generation OCT platform.

Yameena Ratnayake, Cylite’s Quality Manager commented,” We are very proud to have certified our QMS as compliant with ISO 13485:2016. Our team’s focus on creating a “quality-first” culture was critical to achieving this milestone.  To achieve this certification with zero non-conformances in our final assessment  was an added achievement and further confirms the quality-first culture at Cylite.”

“Having an ISO 13485 quality system means that we have validated processes which enable us to innovate efficiently and reliably deliver  our novel 4th generation Hyperparallel OCT platform to the healthcare market,” said Steve Frisken, Cylite’s CEO.

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