Standards & certifications

This International Standard ISO 13485 specifies the requirements for a Quality Management System that can be used by an organization involved in one or more stages of the life-cycle of a medical device. As a provider of Software as Medical Devices, RetinAI complies with the standard requirements, assuring clients and partners of delivering services that meet user needs and expectations with continuous improvement.

The Medical Device Directive is intended to harmonize the laws relating to medical devices within the European Union. By following this Directive, we assure that our Medical Devices are provided in a safe environment that prioritizes our patient’s safety and health conditions.

The General Data Protection Regulation (GDPR) is a regulation law on data protection and privacy in the European Union. By complying with the GDPR, our products and services are based on key principles that provide high level requirements of data protection to our users and partners.

The United States Food and Drug Administration (FDA or USFDA) is responsible for protecting and promoting public health through the control and supervision of medical devices. RetinAI’s Discovery platform has been cleared by FDA through the 510(k) process, which demonstrates that the software is safe and effective.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a US federal law that assures the protection of sensitive patient health information, ensuring it is not disclosed without the patient's consent or knowledge. Within our processes and procedures, we make sure the privacy and security of patients treated with our solutions is safeguarded, in a simple and effective way.