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Validated for Global Scale: DIAGNOS Passes Annual MDSAP Audit, Solidifying the Pathway to Approvals with Health Canada & FDA

BROSSARD, Quebec, Oct. 08, 2025 (GLOBE NEWSWIRE) -- DIAGNOS Inc. (“DIAGNOS” or the ...

articleDiagnos Inc.October 8, 20254/company/diagnos-inc/news/validated-for-global-scale-diagnos-passes-annual-mdsap-audit-solidifying-the-pathway-to-approvals-with-health-canada-and-fda
Validated for Global Scale: DIAGNOS Passes Annual MDSAP Audit, Solidifying the Pathway to Approvals with Health Canada & FDA

About this update from Diagnos Inc.

[{"type":"text","content":"Validated for Global Scale: DIAGNOS Passes Annual MDSAP Audit, Solidifying the Pathway to Approvals with Health Canada & FDA\n\n\n\n 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 (\n \n AI\n \n ), 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.\n \n\n The audit confirmed\n \n full compliance\n \n across all operational and development processes, with\n \n no single non-conformities\n \n raised. This demonstrates DIAGNOS’ strong commitment to quality, regulatory excellence, and continuous improvement.\n \n\n Following this review, Intertek reissued the Company’s certification with an updated scope reflecting DIAGNOS’\n \n Software-as-a-Service (SaaS)\n \n deployment model for its AI-assisted medical image-analysis platform. This evolution aligns the Company’s quality framework with its expanding\n \n global strategy\n \n .\n \n\n Yves-Stéphane Couture, COO of DIAGNOS, stated:\n \n\n “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\n \n accelerating the path to approvals\n \n with\n \n Health Canada, the FDA, and the SFDA\n \n . Our cloud deployment model allows us to deliver innovation faster, securely, and with measurable impact for healthcare providers.”\n \n\n “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.”\n \n\n This successful audit strengthens DIAGNOS’ position in ongoing regulatory submissions and supports its core mission which is centered on supporting Health Care Prof...

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