DIAGNOS Successfully Completes ISO / MDSAP Audit BROSSARD, Quebec, Feb. 10, 2022 (GLOBE NEWSWIRE) -- 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. Andr Larente, President of DIAGNOS.
About 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).
Additional information is available at www.diagnos.com and www.sedar.com.
https://www.globenewswire.com/news-release/2022/02/10/2383058/0/en/DIAGNOS-Successfully-Completes-ISO-MDSAP-Audit.html