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Voxeleron is ISO 13485:2016 Certified

13485 2016

Voxeleron is now ISO 13485:2016 certified.

This key accomplishment, complementing our existing SOC 2 certification and compliance to 21 CFR Part 11 and GDPR, reflects our commitment to quality in the development and delivery of our platform and services, and underlines our priority of data security, traceability and privacy.

ISO 13485:2016 is a globally recognized standard and provides a structured framework that ensures certified companies adhere to stringent quality standards in design, development, testing, and maintenance of ophthalmic software and related services. Our ophthalmic image analysis and clinical trial management platform now meets these rigorous requirements of the medical industry. As we continue to push the boundaries of innovation, we remain committed to delivering cutting-edge technology while upholding the highest standards of efficacy, patient safety, and reliability.

Our customers recognize the paramount importance of data security, integrity, and compliance in the healthcare ecosystem, and the ISO 13485:2016 certification provides them with transparency and the assurance that Voxeleron continues to be a trusted partner.

If you are looking to learn more about advanced OCT analysis and efficient ophthalmic clinical trial management, contact us today to learn more and request a demo.