Harnessing deep learning to prevent blindness

Eyenuk, Inc.

Quality

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ISO 13485:2016 Certified

Eyenuk's quality management system has been independently audited to be compliant with ISO 13485:2016

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MDSAP

Eyenuk's quality management system has been successfully audited under the Medical Device Single Audit Program (MDSAP) and is compliant with regulations of US, Canada, Brazil, and Australia.

Regulatory

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CE Marking

Eyenuk's EyeArt® AI Eye Screening System for Diabetic Retinopathy has CE marking and is approved for sale in the EU as a Class IIa medical device.

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Health Canada License

Eyenuk's EyeArt® AI Eye Screening System for Diabetic Retinopathy has license from Health Canada (#100705) and is approved for sale in Canada as a Class 2 medical device.

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Other Regions

EyeArt is approved for sales is several other global markets and regions. Please contact us to know if EyeArt is approved for sale in your country.

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Other Products

EyeMark™, EyeApp™, EyeSeeAMD™, and EyeSeeGlaucoma™ are under active development and have not yet been cleared for sales in any region.

Cybersecurity

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HIPAA Compliant

Eyenuk has been independently audited by A-Lign to be compliant with HIPAA privacy and security controls.

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GDPR Compliant

Eyenuk is GDPR compliant. For any cybersecurity or privacy related questions or concerns, please contact: securityofficer@eyenuk.com

Would you like to know more?

We are more than happy to answer any question you may have about any of our products. Fill out the form below and someone from our team will get back to you promptly.

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