DIAGNOS Successfully Completes ISO/MDSAP Audit
February 10, 2022 (Source) — Diagnos Inc. (“DIAGNOS”, the “Corporation” or ”we”) (TSX Venture: ADK) (OTCQB: DGNOF) a leader in early detection of critical health issues through the use of its FLAIRE platform based on Artificial Intelligence (AI), announces today that its quality management system continues to comply with the ISO 13485 standard and applicable regulatory requirements for medical devices.
As part of the requirements for the commercialization of our flagship product CARA from Health Canada and the Food and Drug Agency in the US (FDA), DIAGNOS must undergo thorough statutory annual quality compliance audits under the Medical Device Single Audit Program (MDSAP). MDSAP is a comprehensive approach to quality management systems auditing among countries devoted to enhance the safety of medical devices.
“I would like to take this opportunity to thank our employees for their hard work in this important process. Our clients expect our healthcare solutions to perform in compliance with the highest quality standards and DIAGNOS is able to meet their expectations”, said Mr. André Larente, President of DIAGNOS.
DIAGNOS is a publicly traded Canadian corporation dedicated to early detection of critical health problems based on its FLAIRE Artificial Intelligence (AI) platform. FLAIRE allows for quick modifying and developing of applications such as CARA (Computer Assisted Retina Analysis). CARA’s image enhancement algorithms provide sharper, clearer and easier-to-analyze retinal images. CARA is a cost-effective tool for real-time screening of large volumes of patients. CARA has been cleared for commercialization by the following regulators: Health Canada, the FDA (USA), CE (Europe), COFEPRIS (Mexico) and Saudi FDA (Saudi Arabia).
For further information, please contact:
Mr. André Larente, President
Tel: 450-678-8882 ext. 224
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.
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