Cylite receives ISO 13485 Certification
Cylite Pty Ltd, a developer and manufacturer of 4th Generation OCT systems for Ophthalmology and Optometry, is pleased to announce that it has been awarded International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems (QMS) following review by BSI. ISO 13485:2016 is an internationally recognized 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 attain 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.
Founded in 2013, Cylite Pty Ltd is an Australian-based company who are developing the next generation of diagnostic OCT systems for Ophthalmology and Optometry. Cylite’s Hyperparallel OCT (HP-OCT) system has been engineered to give industry-leading A-scan speeds, capturing volume data to provide accurate analytics for corneal and refractive specialists. This 4th generation OCT platform overcomes the eye-motion limitations of previous generations of OCT.
Our vision is to provide whole eye diagnostics, superior imaging quality, and accurate analytics to enable clinicians to make more informed decisions for better patient outcomes.
For more information, visit www.cyliteoptics.com