11:44 AM EDT, 10/08/2025 (MT Newswires) -- DIAGNOS ( DGNOF ) Wednesday said it has completed the annual surveillance external quality compliance audit under the Medical Device Single Audit Program (MDSAP), which it says "solidifies" its pathway to Health Canada and FDA approval.

The audit, conducted last June, confirmed full compliance across all operational and development processes, with no single non-conformities raised, the company said. Intertek has reissued Diagnos' ( DGNOF ) certification with an updated scope reflecting its Software-as-a-Service (SaaS) deployment model for its AI-assisted medical image-analysis platform.

"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 ( DGNOF ) is accelerating the path to approvals with Health Canada, the FDA, and the SFDA," said Yves-Stephane Couture, chief operating officer.

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