Mr. Yves-Stephane Couture reports

VALIDATED FOR GLOBAL SCALE: DIAGNOS PASSES ANNUAL MDSAP AUDIT, SOLIDIFYING THE PATHWAY TO APPROVALS WITH HEALTH CANADA & FDA

Diagnos Inc. has successfully completed the annual surveillance external quality compliance audit under the medical device single audit program (MDSAP), performed in June of this year.

The audit confirmed full compliance across all operational and development processes, with no single non-conformities raised. This demonstrates Diagnos's strong commitment to quality, regulatory excellence and continuous improvement.

Following this review, Intertek reissued the company's certification with an updated scope reflecting Diagnos's software-as-a-service (SaaS) deployment model for its AI-assisted (artificial intelligence) medical image analysis platform. This evolution aligns the company's quality framework with its expanding global strategy.

Yves-Stephane Couture, chief operating officer of Diagnos, stated: "This renewed certification demonstrates our readiness to scale our SaaS-based AI platform globally while maintaining the rigorous quality and compliance standards required by regulators. It's a strong signal to our partners and licensing bodies -- Diagnos is accelerating the path to approvals with Health Canada, the FDA and the SFDA. Our cloud deployment model allows us to deliver innovation faster, securely and with measurable impact for health care providers.

"I would like to sincerely thank our quality, conformity and regulatory affairs specialist, Mr. Eric Boucher, and all Diagnos employees for their dedication throughout this process. Our clients expect our health care solutions to perform in compliance with the highest standards -- and Diagnos continues to meet and exceed those expectations."

This successful audit strengthens Diagnos's position in continuing regulatory submissions and supports its core mission, which is centred on supporting health care professionals (HCP) in early detection of critical health issues using AI.

About MDSAP

MDSAP is a regulatory audit program of a medical device manufacturer's quality management system. The program aims to reduce the number of audits a manufacturer undergoes by allowing a single annual audit to meet the regulatory needs of participating countries, which include assessing compliance with ISO 13485 and country-specific regulations.

About ISO 13485

ISO 13485 is the harmonized standard for quality management system (QMS) in the medical device manufacturing industry. It outlines the requirements needed for organizations to establish a QMS that demonstrates the capability to consistently and safely deliver medical devices, and related services, as well as meeting customer and regulatory requirements.

About Diagnos Inc.

Diagnos is a publicly traded Canadian corporation dedicated to early detection of critical eye-related health problems. By leveraging AI, Diagnos aims to provide more information to health care clinicians to enhance diagnostic accuracy, streamline workflows and improve patient outcomes on a global scale.

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