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

Core Insights - DIAGNOS Inc. has successfully completed its annual surveillance external quality compliance audit under the Medical Device Single Audit Program (MDSAP), confirming full compliance with no non-conformities [1][2] - The audit results led to the reissuance of the company's certification, reflecting its Software-as-a-Service (SaaS) deployment model for its AI-assisted medical image-analysis platform, aligning with its global strategy [3] Compliance and Quality Assurance - The audit confirmed that DIAGNOS adheres to rigorous quality and regulatory standards, demonstrating a strong commitment to continuous improvement [2] - The MDSAP program aims to streamline regulatory audits for medical device manufacturers, allowing a single annual audit to meet the requirements of multiple countries [4] Company Strategy and Future Outlook - The renewed certification signals DIAGNOS' readiness to scale its SaaS-based AI platform globally while maintaining compliance with regulatory standards [3] - The company emphasizes its mission to support healthcare professionals in the early detection of critical health issues using AI technology [3][6]