New York, August 17, 2026
Intelligent Bio Solutions Inc. announced that its Intelligent Fingerprinting Drug Screening business has received ISO 13485:2016 recertification, strengthening the company’s quality management framework as it advances its regulatory strategy in the United States. The recertification was issued by the British Standards Institution (BSI) and is effective from October 14, 2026, with validity extending for three years. The certification is particularly relevant to the company’s ongoing efforts to obtain FDA clearance for its Intelligent Fingerprinting Drug Screening System, which is being developed as a rapid, non-invasive testing platform using fingerprint sweat samples. Intelligent Bio Solutions said the recertification demonstrates alignment with the internationally recognized quality management standard for medical devices and supports its operations across regulated markets. The company is currently pursuing FDA clearance for detection of codeine, an opiate, using its fingerprint-based drug screening technology.
ISO 13485 Recertification Supports FDA Regulatory Strategy
The ISO 13485:2016 recertification represents an important quality and regulatory milestone for Intelligent Bio Solutions because the standard is directly relevant to the FDA’s updated Quality Management System Regulation (QMSR). The amended FDA QMSR became effective on February 2, 2026, incorporating ISO 13485:2016 by reference into the agency’s medical device quality requirements. Intelligent Bio Solutions operates an FDA-registered facility in the United Kingdom, and maintaining ISO 13485:2016 certification provides a quality framework aligned with the standard incorporated into the new U.S. regulation. The company said this alignment supports its broader compliance efforts while it progresses its application for FDA clearance. However, ISO certification does not itself mean FDA clearance has been granted. The regulatory application remains under review and additional FDA requirements must still be satisfied before the Intelligent Fingerprinting Drug Screening System can be marketed for the proposed U.S. indication.
Intelligent Fingerprinting Technology Supports Non-Invasive Testing
Intelligent Bio Solutions’ fingerprint drug screening system is designed to provide portable and rapid testing by analyzing drug compounds present in fingerprint sweat. The company describes the technology as a non-invasive and hygienic testing approach, with sample collection completed within seconds and results potentially available in less than ten minutes. The system is designed to screen for commonly encountered drugs including opiates, cocaine, methamphetamine and cannabis, with applications particularly relevant to workplace testing and safety-critical environments. Outside the United States, the company’s customer base includes organizations in sectors such as construction, manufacturing, engineering, transportation, logistics, mining and drug treatment, as well as coroners. The company’s regulatory progress could therefore become an important step toward expanding availability of its fingerprint-based testing platform into the U.S. market. At the same time, the commercial opportunity remains dependent on regulatory clearance and successful execution of the company’s broader market strategy.
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Dual Quality Certifications Strengthen Medical Device Operations
In addition to ISO 13485:2016, Intelligent Bio Solutions has completed recertification to ISO 9001:2015, another internationally recognized quality management standard. Together, the certifications reinforce the company’s quality systems across the jurisdictions in which it currently operates. ISO 13485 specifically addresses quality management requirements applicable to organizations involved in the design, development, production and supply of medical devices, making the recertification particularly relevant to Intelligent Bio Solutions’ medical technology operations. The company said the continued certification supports its ability to operate across international markets including the United States, Canada, Europe and Asia Pacific. For cGxP.wire, the key development is the company’s strengthened quality infrastructure at a time when it is pursuing U.S. regulatory clearance for its fingerprint-based drug screening system. The next major milestone will be progress toward FDA clearance, rather than the ISO recertification itself, as successful regulatory authorization would determine the system’s ability to enter the U.S. market for its proposed application.
Source: Intelligent Bio Solutions press relese
