Intelligent Bio Solutions Secures ISO Recertification, Aligning With New FDA QMSR

(RTTNews) - Intelligent Bio Solutions Inc. (INBS), a medical technology company, announced that its Intelligent Fingerprinting Drug Screening business has secured recertification to the ISO 13485:2016 quality management system standard, with the certification issued by the British Standards Institution (BSI) effective October 14, 2026, valid for three years.

ISO 13485:2016 is the internationally recognised quality management standard for organisations involved in the design, development, production, and supply of medical devices.

The recertification comes as the U.S. FDA's Quality Management System Regulation (QMSR) took effect on February 2, 2026, formally updating its quality management system requirements by referencing ISO 13485:2016.

The company is advancing clinical studies and preparing its FDA 510(k) submission for clearance of the Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

"This directly supports our efforts to secure FDA clearance," said Callistus Sequeira, Vice President of Global Quality & Operations at Intelligent Bio Solutions.

INBS has traded between $1.52 and $24.90 over the last year. The stock closed Monday's trade at $3.37, up 21.66%.

In the pre-market, INBS is down 2.08% at $3.30.

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