Zilia Receives ISO 13485:2016 Certification
Zilia has received certification from Intertek that its quality management system meets the ISO 13485 : 2016 standard for ophthalmic technologies enabling the measurement of biomarkers in the eye.
This crucial quality seal underscores the company’s expertise in a highly regulated industry and paves the way for further development and innovation in the non-invasive assessment of ocular biomarkers.
“The certification marks an important milestone in Zilia’s growth and shows that the company meets the most current quality standards and further validates our commitment to excellence, safety and delivering outstanding products.“
Karina Leblanc, Director of Quality and Regulatory Affairs
ISO 13485:2016 is an internationally recognized quality standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product.
Zilia has developed the world’s first and only retinal camera to measure oxygen saturation in the eye, a crucial biomarker in ocular diseases such as glaucoma and diabetic retinopathy. This groundbreaking technology is bound to redefine the way we prevent, diagnose, and treat these blinding diseases. In addition, because the eye is a unique window into a person’s health, Zilia’s platform technology can be adapted to assess a vast array of biomarkers present in the eye, paving the way for other applications in neurology, cardiology, oncology, and more.
Contact: [email protected]
Written by the Zilia team on May 31, 2022
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