AI/ML Innovations' Tech2Heal Starts Medical Device ISO 13485 Certification Process
TORONTO, ON / ACCESSWIRE / June 22, 2022 / AI/ML Innovations Inc. (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB), a company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to announce that its minority-owned subsidiary, Tech2Heal SAS, has reported that it is undertaking the certification of its products and services in accordance with the internationally agreed standard for medical devices: ISO 13485:2016.
Tech2Heal is committed to guaranteeing the safety and quality of the digital health products and services it produces, from design to recycling. ISO 13485:2016 sets out the requirements for a quality management system whereby an organization must demonstrate its ability to consistently provide medical devices and related services that meet customer and applicable regulatory standards.
"We take our commitment to providing the best-in-class products and services extremely seriously. Safety and quality cannot be subjective. Our customers will have the peace of mind in knowing that our products have met and surpassed the exacting standards of ISO 13485," said Fabrice Pakin, CEO of Tech2Heal. "An added benefit to this ISO certification is that it will also aid in our garnering the coveted "CE" marking on Tech2Heal products, in part by allowing internal self-certifications governed by the ISO procedures in place".
About Tech2Heal
Tech2Heal is a Paris, France based healthcare innovator specializing in digital health technologies with the objective of creating a compassionate, collaborative and patient-centered healthcare ecosystem. T2H has developed a portfolio of health-tech products and services designed to improve an individual's mental and physical well-being by utilizing a unique blend of proprietary digital assets and remote live counselling.
Tech2Heal's premier products include Qookka - clinically supported and evidence-based digital therapy for anxious and depressed patients delivered via a secure digital platform, and Alakin - a bespoke, digital remote patient monitoring platform designed for healthcare providers and pharma.
For more information: https://www.tech2heal.com/
About AI/ML Innovations Inc.
AI/ML Innovations Inc. has realigned its business operations to capitalize on the burgeoning fields of artificial intelligence (AI) and machine learning (ML), with an initial investment focus on emerging digital health and wellbeing companies that leverage AI, ML, cloud computing and digital platforms to drive transformative healthcare management solutions and precision support delivery across the health continuum. Through strategic partnerships with Health Gauge (
On behalf of the Board of Directors
Tim Daniels, Executive Chairman
For more information about AI/ML Innovations:
For detailed information please see AI/ML's website at https://aiml-innovations.com/ or the Company's filed documents at www.sedar.com.
For further information: Blake Fallis at (778) 405-0882 or info@aiml-innovations.com.
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Certain information in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company, including but not limited to, the uncertainty of competition by other industry players, the impact of general economic conditions, industry conditions, dependence upon regulatory approvals and the ability to raise additional capital as may be needed in the future. Readers are cautioned that the assumptions used in preparing such information, although considered reasonable at the time of preparation, may prove imprecise and undue reliance should not be placed on forward-looking statements. Forward-looking statements in this press release are expressly qualified by this cautionary statement.
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SOURCE: AI/ML Innovations Inc.
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