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RETGUARD

Regulatory Compliance

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RetGuard is committed to meeting the highest standards of regulatory compliance for medical technology. This page provides an overview of the compliance status of our products and our approach to quality and regulatory affairs.

1. Product Classification

The RetGuard screening software is classified as a clinical decision support tool designed to assist qualified healthcare professionals in retinal disease screening. It provides screening results, calibrated confidence scores, and visual evidence to support clinical judgment.

RetGuard does not make autonomous diagnostic decisions. All screening outputs are intended to be reviewed, interpreted, and acted upon by qualified healthcare providers. The system is designed to support — not replace — professional medical judgment.

2. Hardware Compliance

The RetGuard system comprises two hardware components, each with independent compliance certification:

  • RetGuard Camera: The retinal imaging device carries CE marking as a conformity-assessed medical imaging device, meeting the applicable requirements of the relevant EU directives.
  • RetGuard Box: The AI processing unit, built on the NVIDIA Jetson Orin NX platform, is CE marked as an electronic computing device in accordance with applicable electromagnetic compatibility and safety standards.

3. Quality Management

RetGuard maintains quality management practices aligned with ISO 13485 — the international standard for quality management systems specific to the medical device industry. Our quality framework covers design controls, risk management, production processes, and post-market surveillance activities.

4. Regulatory Pathway

RetGuard is pursuing appropriate regulatory clearances and approvals in its target markets. This includes the FDA 510(k) clearance pathway in the United States, as well as conformity assessment processes in other jurisdictions where the RetGuard system will be distributed.

Our regulatory strategy is informed by the classification of RetGuard as a clinical decision support tool and the applicable regulatory frameworks for AI-based medical software in each market.

5. Export Considerations

Certain components of the RetGuard system may be subject to export control regulations, including restrictions on the transfer of medical devices and electronic equipment to specific jurisdictions. Customers and distribution partners are responsible for ensuring compliance with all applicable import and export laws and regulations in their respective jurisdictions.

RetGuard does not knowingly sell or distribute its products to sanctioned countries or entities. For questions regarding export eligibility, please contact our regulatory affairs team.

6. Contact

For questions about our regulatory compliance, certification status, or quality management system, please contact: