Intelligent Bio Solutions Strengthens Quality Management Credentials with ISO Recertification
Intelligent Bio Solutions (Nasdaq: INBS) announced recertification of its Intelligent Fingerprinting Drug Screening business to the ISO 13485:2016 medical device quality management standard.
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Rhea-AI Summary
Intelligent Bio Solutions (Nasdaq: INBS) announced recertification of its Intelligent Fingerprinting Drug Screening business to the ISO 13485:2016 medical device quality management standard. The new certificate, issued by the British Standards Institution, becomes effective October 14, 2026 and is valid for three years.
According to the company, this aligns its UK FDA-registered facility with the ISO 13485:2016 standard incorporated into the FDA’s amended Quality Management System Regulation, supporting its ongoing FDA clearance application for codeine detection. INBS also completed ISO 9001:2015 recertification, supporting operations across regulated markets in the US, Canada, Europe, and Asia Pacific.
Positive
- ISO 13485:2016 recertification effective October 14, 2026, valid three years
- Alignment with FDA QMSR via ISO 13485:2016 supports FDA clearance strategy
- ISO 9001:2015 recertification completed for broader quality management systems
- Certified operations support access to highly regulated markets in US, Canada, Europe, Asia Pacific
Negative
- None.
Details
Market move: INBS +21.66% in the Aug 17 session. ISO recertification
On Aug 17, the day this news came out, INBS closed 21.66% above the previous close. Argus tracked a peak move of +17.9% during that session. Our momentum scanner recorded 16 alerts for this stock that day. Relative volume reached 5.0x the daily average during tracking.
Data tracked by StockTitan Argus for the Aug 17 session.
Key Figures
- Certification standard
- ISO 13485:2016
- Intelligent Fingerprinting Drug Screening business recertification
- Recertification effective date
- October 14, 2026
- BSI-issued ISO 13485:2016 recertification
- Certification validity
- Three years
- ISO 13485:2016 recertification
- QMSR effective date
- February 2, 2026
- FDA amended Quality Management System Regulation
- Additional certification
- ISO 9001:2015
- Completed quality management system recertification
Historical Context
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Completed multi-site study supporting the FDA 510(k) submission
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Completed usability study supporting FDA 510(k) submission
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Completed interference study evaluating everyday-substance effects
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Completed remediation of cybersecurity and software review items
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Completed precision testing across more than 1,600 tests
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
iso 13485:2016 regulatory
quality management system regulation regulatory
iso 9001:2015 regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
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. Both certifications confirm that the Company’s quality systems conform to the requirements of ISO 13485:2016 and ISO 9001:2015, respectively, in the jurisdictions in which the Company currently operates.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.
For more information, visit: https://ibs.inc/
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, secure regulatory clearance or approvals, and timelines to enter the U.S. market, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results may differ materially from those expressed or implied by such statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” and “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Company Contact
Intelligent Bio Solutions Inc.
info@ibs.inc
Investor & Media Contact
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
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