Intelligent Bio Solutions Strengthens Quality Management Credentials with ISO Recertification

About this update from Intelligent Bio Solutions Inc.

Recertification aligns with the FDA's newly amended Quality Management System Regulation and supports the Company's regulatory strategy as it pursues FDA clearance NEW YORK, Aug. 17, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that its Intelligent Fingerprinting Drug Screening business has been recertified to the ISO 13485:2016 quality management system standard, the internationally recognized benchmark for medical device manufacturers. The recertification, issued by the British Standards Institution (BSI), is effective October 14, 2026, and will be valid for three years. On February 2, 2026, the U.S. FDA's amended Quality Management System Regulation (QMSR) came into effect, formally updating its quality management system requirements by incorporating ISO 13485:2016 by reference. As an FDA-registered facility in the UK, the Company's ISO 13485:2016 certification demonstrates alignment with the standard the FDA has incorporated into the QMSR, supporting its broader compliance efforts. This reinforces the Company's regulatory strategy as it actively progresses its application for FDA clearance of the Intelligent Fingerprinting Drug Screening System for the detection of the opiate codeine. "High-quality standards are something we take seriously at every level of the business," said Callistus Sequeira, Vice President of Global Quality & Operations at Intelligent Bio Solutions. "With the FDA's Quality Management System Regulation now in effect and incorporating ISO 13485:2016, our existing certification and FDA-registered facility status mean the quality framework underpinning our operations is aligned with the standard at the core of the new regulation. This directly supports our efforts to secure FDA clearance." ISO 13485:2016 is the internationally recognized quality management standard for organizations involved in the design, development, production, and supply of medical devices. Maintaining certification supports the Company's continued operations across highly regulated international markets, including the United States, Canada, Europe, and Asia Pacific. The Company has also completed recertification to ISO 9001:2015, the internationally recognized standard for quality management systems....

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