Validated for Global Scale: DIAGNOS Passes Annual MDSAP Audit, Solidifying the Pathway to Approvals with Health Canada & FDA
MWN-AI** Summary
DIAGNOS Inc., a Canadian leader in early detection of health issues through Artificial Intelligence (AI), has successfully completed its annual Medical Device Single Audit Program (MDSAP) audit. Conducted in June 2025, the audit confirmed full compliance with no non-conformities, underscoring the company's commitment to quality and regulatory excellence. Following this audit, Intertek has updated DIAGNOS' certification to reflect its transition to a Software-as-a-Service (SaaS) model for its AI-assisted medical image-analysis platform, aligning with its global expansion strategy.
Yves-Stéphane Couture, COO of DIAGNOS, emphasized that the renewed certification signifies the company’s readiness to scale its SaaS-based AI platform while adhering to stringent regulatory standards. This development enhances DIAGNOS' prospects for approvals from regulatory authorities such as Health Canada, the FDA, and the SFDA, with the cloud-based model designed to facilitate faster and secure innovation delivery.
The MDSAP framework allows manufacturers to streamline regulatory compliance by undergoing a single audit to meet the varied regulatory demands of participating countries, thus reducing the frequency of audits. Additionally, DIAGNOS adheres to ISO 13485, the recognized standard for quality management systems in the medical device sector, which outlines the criteria for organizations to provide safe and effective medical devices.
DIAGNOS aims to leverage its AI technology to improve diagnostic accuracy and healthcare outcomes on a global scale. With its commitment to exceeding professional healthcare standards, DIAGNOS is well-positioned for future growth and partnerships. The company continues to support healthcare professionals by enhancing early detection capabilities for critical health issues.
MWN-AI** Analysis
DIAGNOS Inc. (TSX Venture: ADK, OTCQB: DGNOF), a frontrunner in AI-driven healthcare solutions, has recently completed its annual surveillance audit under the Medical Device Single Audit Program (MDSAP) without any non-conformities. This achievement underscores the company’s unwavering dedication to quality and regulatory compliance, positioning DIAGNOS favorably as it seeks approvals from Health Canada, the FDA, and the Saudi Food and Drug Authority (SFDA) for its innovative medical image-analysis platform.
The successful MDSAP audit not only enhances DIAGNOS’ credibility in the global market but also aligns with its Software-as-a-Service (SaaS) deployment model. This strategic evolution allows DIAGNOS to expedite the delivery of its AI solutions while ensuring adherence to the highest regulatory standards. The emphasis on quality and compliance is likely to reassure both existing and potential partners about the scalability of DIAGNOS' technology.
From a market perspective, DIAGNOS represents an attractive investment opportunity for several reasons. The company's effective integration of AI in healthcare, especially for early detection of critical health issues, positions it at the forefront of a rapidly growing sector. The global healthcare AI market is projected to expand significantly, and DIAGNOS' secure cloud deployment model enhances its ability to leverage this growth. Investors should be mindful of the inherent risks associated with the regulatory landscape; however, DIAGNOS’ successful audit mitigates some of these concerns.
For potential investors, keeping an eye on upcoming developments, including regulatory approvals and partnerships, will be essential. The recent audit and its outcomes signal strong operational health and market readiness, making DIAGNOS a compelling proposition as it continues to push boundaries in healthcare technology.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
BROSSARD, Quebec, Oct. 08, 2025 (GLOBE NEWSWIRE) -- DIAGNOS Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in early detection of critical health issues using advanced technology based on Artificial Intelligence ( AI ), announces the successful completion of 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’ strong commitment to quality, regulatory excellence, and continuous improvement.
Following this review, Intertek reissued the Company’s certification with an updated scope reflecting DIAGNOS’ Software-as-a-Service (SaaS) deployment model for its AI-assisted medical image-analysis platform. This evolution aligns the Company’s quality framework with its expanding global strategy .
Yves-Stéphane Couture, COO 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 healthcare providers.”
“I would like to sincerely thank our Quality, Conformity, & Regulatory Affairs Specialist, Mr. Eric Boucher, and all DIAGNOS employees for their dedication throughout this process. Our clients expect our healthcare solutions to perform in compliance with the highest standards — and DIAGNOS continues to meet and exceed those expectations.”
This successful audit strengthens DIAGNOS’ position in ongoing regulatory submissions and supports its core mission which is centered on supporting Health Care Professionals (HCP) in early detection of critical health issues using Artificial Intelligence (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
DIAGNOS is a publicly traded Canadian corporation dedicated to early detection of critical eye-related health problems. By leveraging Artificial Intelligence, DIAGNOS aims to provide more information to healthcare clinicians to enhance diagnostic accuracy, streamline workflows, and improve patient outcomes on a global scale.
Additional information is available at www.diagnos.com and www.sedarplus.com .
This press release contains forward-looking information. We cannot guarantee that the forward-looking information mentioned will prove to be accurate, as there may be a significant discrepancy between actual results or future events and those mentioned in this statement. DIAGNOS disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise. The forward-looking information contained in this press release is expressly covered by this caution.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For further information, please contact:Mr. André Larente, PresidentDIAGNOS Inc.Tel: 450-678-8882 ext. 224alarente@diagnos.ca
FAQ**
How does DIAGNOS Inc. ADK:CC plan to leverage its recent MDSAP certification to accelerate its global strategy and what specific markets are being targeted for expansion?
What measures is DIAGNOS Inc. ADK:CC taking to ensure its Software-as-a-Service (SaaS) model continues to adhere to the high-quality standards outlined in the ISO 13485 framework?
With DIAGNOS Inc. ADK:CC’s commitment to early detection of critical health issues, how does the company plan to improve the efficacy of its AI-assisted medical image-analysis platform in diverse healthcare environments?
Can DIAGNOS Inc. ADK:CC outline the expected timeline and milestones for its ongoing regulatory submissions with Health Canada, the FDA, and the SFDA following the successful audit completion?
**MWN-AI FAQ is based on asking OpenAI questions about Diagnos Inc. (TSXVC: ADK:CC).
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