DIAGNOS Successfully Completes ISO 13485 / MDSAP Audit
January 21, 2021 (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 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 each of our employees for their hard work and commitment to the quality of our products. Our clients expect our healthcare solutions to perform in compliance with the highest quality standards, while being safe, and DIAGNOS is able to meet their expectations”, said Mr. André Larente, President of DIAGNOS.
DIAGNOS is a publicly-traded Canadian corporation with a mission of early detection of critical health issues through the use of its Artificial Intelligence (“AI”) tool CARA (Computer Assisted Retina Analysis). CARA is a tele-ophthalmology platform that integrates with existing equipment (hardware and software) and processes at the point of care. CARA’s Artificial Intelligence image enhancement algorithms make standard retinal images sharper, clearer and easier to read. CARA is accessible securely over the internet, and is compatible with all recognized image formats and brands of fundus cameras, and is EMR compatible. CARA is a cost-effective tool for screening large numbers of patients in real-time. CARA complies with local regulations, is FDA cleared for commercialization in the United States of America, is Health Canada licensed for commercialization in Canada, licensed by the Saudi FDA, COFEPRIS in Mexico and is CE marking compliant in Europe.
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.
This news release may contain forward-looking information. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in these statements. DIAGNOS disclaims any intention or obligation to publically 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 news release is expressly qualified by this cautionary statement.
InvestorIntel.com is a leading online source of investor information that provides public market coverage for both investors and industry alike. A qualified online influencer through ... <Read more about InvestorIntel>