Diagnos Inc. meets compliance requirements for ISO 13485 standard
This certification covers AI based regulatory requirements for the company's platform for AI imaging and diagnostic tools.
(Image credit: AdobeStock/Davin)
Diagnos Inc. has announced that its quality management system is fully compliant with ISO 13485 standard and applicable regulatory requirements for medical devices.
As part of the requirements for the commercialization of the company’s flagship product CARA, DIAGNOS must undergo thorough statutory quality compliance audits under the Medical Device Single Audit Program (MDSAP).1
Yves-Stephane Couture, Chief Operating Officer of DIAGNOS, noted in the company’s press release1 that this certification is approved by multiple governments, including Canada and the US. He said, “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. Without this certification we are not allowed to sell our solutions worldwide. This new certification also covers all new AI based regulatory requirements that have been approved by multiple governments including: Canada, USA and European countries.”
Similarly, André Larente, President of DIAGNOS, marked the milestone for the company and shared the future expectations of DIAGNOS, saying, “This huge achievement from our team comes at a time where Artificial Intelligence is growing and we want to be the leader in our field. DIAGNOS has reached an inflection point in its sales growth going from a one test company for diabetics to a company providing a suite of tests thereby accelerating profitability and patient satisfaction. A report from Precedence Research said that the global artificial intelligence (AI) in the healthcare Market size, which was USD 19.27 billion in 2023 is estimated at 26.69 billion in 2024 and is anticipated to reach around USD 613.81 billion by 2034, expanding at a CAGR of 36.83% from 2024 to 2034.”1
According to the company1, DIAGNOS is currently in the process of obtaining regulatory licenses in Canada (Health Canada) and in the USA (US-FDA) for 4 additional modules to assist health care professionals in identifying generally abnormal through optical coherence tomography retinal images and in the grading of fundus images to detect signs of retinopathy for general public adult, age-related macular degeneration, diabetic retinopathy and hypertensive retinopathy.
