Quality Management System Certification Strengthens NeuralCloud’s Regulatory Readiness for ECG Software-as-a-Medical-Device Platform
Toronto, Canada – August 11, 2026 - AI/ML Innovations Inc. (“AIML” or the “Company”) (CSE: AIML; OTCQB: AIMLF; FWB: 42FB), a company advancing artificial intelligence and neural-network-based technologies for digital health, is pleased to announce that its wholly owned subsidiary, NeuralCloud Solutions Inc. (“NeuralCloud”), has achieved ISO 13485:2016 certification under the Medical Device Single Audit Program (“MDSAP”) for its quality management system.
The certification, issued by TÜV USA, Inc., applies to NeuralCloud’s quality management system for the design, development, production, and distribution of Software as a Medical Device (“SaMD”) for ECG analysis, including advanced PQRST waveform delineation, interval computation, arrhythmia analytics, signal quality scoring, and artifact reporting.
ISO 13485 is the internationally recognized quality management system standard for medical devices, while MDSAP is a global regulatory audit program that allows a single audit of a medical device manufacturer’s quality management system to support requirements across multiple participating regulatory jurisdictions.
For NeuralCloud, certification under ISO 13485:2016 (MDSAP) establishes an audited quality framework to support the Company’s ongoing regulatory, clinical, and commercialization activities for its ECG-focused SaMD technologies, including MaxYield™ and CardioYield™.
“This certification is significant for NeuralCloud,” said Esmat Naikyar, President of NeuralCloud Solutions Inc. and Chief Product Officer of AIML. “Building advanced AI for cardiac signal interpretation is only one part of becoming a true medical device company. Equally important is having the quality system, documentation, controls, and audit readiness required to support safe, reliable, and regulated medical software. Achieving ISO 13485:2016 (MDSAP) certification demonstrates that NeuralCloud has built that foundation.”
For NeuralCloud, ISO 13485:2016 (MDSAP) certification is an important part of the Company’s regulatory-readiness strategy. MDSAP allows a recognized auditing organization to conduct a single quality management system audit that can be used by multiple participating regulatory authorities, reducing the total audit and inspection burden that multi-market medical device manufacturers may otherwise face. The program is designed to satisfy quality-system requirements across participating jurisdictions, including Canada, the United States, Australia, Brazil, and Japan, while supporting greater consistency, predictability, and transparency in medical device oversight.
One of the key practical benefits of MDSAP is that a single, recognized audit cycle can support ongoing quality-system surveillance expectations across multiple jurisdictions. In the United States, participation in MDSAP is voluntary; however, the FDA has stated that it will accept MDSAP audit reports as a substitute for routine FDA inspections, helping reduce duplicative routine inspection activity for certified manufacturers. In Canada, MDSAP is mandatory for a medical device license and certification is a key requirement for manufacturers seeking Class II, III, or IV medical device licences. Accordingly, NeuralCloud believes this certification strengthens its position as it advances its medical device strategy and prepares for future regulatory submissions and market opportunities.
While MDSAP supports quality-system regulatory readiness, it does not itself constitute product clearance or marketing authorization, nor does it replace applicable premarket review requirements. The FDA also retains authority to conduct inspections when required, including for-cause inspections related to complaints, recalls, adverse events, or other regulatory concerns.
“This is an important step in AIML and NeuralCloud’s regulatory-readiness strategy,” said Paul Duffy, Executive Chairman and CEO of AIML. “It reflects the Company’s commitment to building not only innovative technology, but the regulated infrastructure required to bring that technology into clinical use. As we advance our medical device strategy, this certification strengthens our ability to engage regulators, clinical partners, healthcare systems, and commercial customers with confidence.”
The certification supports NeuralCloud’s broader strategy to deliver scalable AI-powered cardiac diagnostics across clinical, remote monitoring, telehealth, OEM, and research environments. NeuralCloud’s ECG software platforms are designed to transform raw cardiac signals into structured, clinically useful outputs that support faster interpretation, improved workflow efficiency, and broader access to high-quality cardiac insights.
The Medical Device Single Audit Program is a regulatory audit program that allows a recognized auditing organization to conduct a single audit of a medical device manufacturer’s quality management system. The program is based on ISO 13485 and incorporates additional regulatory requirements from participating jurisdictions. MDSAP is intended to reduce duplication, promote regulatory efficiency, and support consistent oversight of medical device manufacturers while maintaining high standards for device safety and quality.
NeuralCloud Solutions Inc., a wholly owned subsidiary of AIML Innovations Inc., develops artificial intelligence and neural-network-based technologies for ECG signal analysis and cardiac software applications. Its platforms are designed to enhance ECG signal quality, support advanced waveform interpretation, enable arrhythmia analytics, and improve clinical workflow efficiency across regulated healthcare environments.
AIML Innovations Inc. is a global technology company pioneering the use of artificial intelligence and neural networks to transform digital health. Our proprietary platforms leverage advanced signal processing and deep learning to convert complex biometric data into actionable clinical insights - supporting earlier diagnosis, personalized treatment, and more effective care.
AIML's shares trade on the Canadian Securities Exchange (CSE: AIML), the OTCQB Venture Market (AIMLF), and the Frankfurt Stock Exchange (42FB).
For detailed information please see AIML's website at https://www.aiml.health or the Company's filed documents at www.sedarplus.ca.
AIML Contact:
Paul Duffy, Executive Chairman and CEO
416-941-8900
Neither the CSE nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statements – Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties, including risks associated with the implementation of the Company's products and services as currently proposed or at all. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company, including with respect to the nature and timing of future operations and the receipt of all applicable regulatory approvals. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements.