Intelligent Bio Solutions wins ISO 13485 recertification for drug screening

Intelligent Bio Solutions Inc. (NASDAQ: INBS) announced that its Intelligent Fingerprinting Drug Screening business has been recertified to the ISO 13485:2016 quality management system standard by the British Standards Institution (BSI).

The recertification takes effect October 14, 2026, and is valid for three years. The company also completed recertification to ISO 9001:2015.

The U.S. FDA's amended Quality Management System Regulation (QMSR), which came into effect February 2, 2026, incorporated ISO 13485:2016 by reference. The company said its existing certification, held as an FDA-registered facility in the UK, aligns with that standard.

Callistus Sequeira, Vice President of Global Quality & Operations at Intelligent Bio Solutions, said: "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."

The company said the certifications support its ongoing application for FDA clearance of the Intelligent Fingerprinting Drug Screening System for the detection of the opiate codeine, as well as its continued operations in regulated markets including the United States, Canada, Europe, and Asia Pacific.

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