Full Press Release Details
Bio Solutions Obtains ISO Recertification
its Intelligent Fingerprinting Drug Screening Business
certification adds to Quality Management Systems credentials for the medical device industry and supports expansion plans into North
America and Asia Pacific regions
YORK, September 27, 2023 - 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 obtained recertification for the latest ISO 13485: 2016 harmonized quality management system standard for
the medical device industry. The recertification is effective October 14, 2023, and will be valid for three years.
13485:2016 is the international standard for medical devices quality management system certification and is a requirement for medical
device manufacturers operating across key regions, including the USA, Canada, Europe, Japan, Singapore, Malaysia and Saudi Arabia. Last
year the US Food and Drug Administration published a proposed rule to harmonize its medical device quality management system, 21 CFR
Part 820, to the ISO 13485 QMS standard.
ISO 13485: 2016 certification confirms that our research and development, manufacturing facilities and operations for our drug screening
products conform with the highest quality management system requirements for our target markets," said Harry Simeonidis, President
and Chief Executive Officer of Intelligent Bio Solutions. "We are currently focused on driving sales growth for our Intelligent
Fingerprinting Drug Screening System across Europe and Australia. In the coming months, we plan to extend our sales efforts into other
countries throughout the Asia Pacific region. Given this planned expansion, it is essential we meet the most stringent quality criteria
recognized globally."
ISO 13485:2016 harmonized standard specifies the requirements for a quality management system where an organization must demonstrate
its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Based
on the ISO 9001 process model, ISO 13485 includes particular elements needed for organizations involved in the lifecycle of medical devices.
The Intelligent Fingerprinting business has also been recertified for the ISO 9001:2015 quality standard.
Intelligent Fingerprinting Drug Screening System is designed to detect the presence of specific drugs and/or their metabolites
from fingerprint sweat. The system features a small, tamper-evident drug screening cartridge onto which ten fingerprint sweat samples
are collected in less than a minute. The tamper-proof cartridges screen for multiple drug groups simultaneously, including combinations
of opioids, cocaine, methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine, in an approach that offers a dignified,
non-invasive, and rapid drug screening solution. The application of the technology in maintaining workplace safety has garnered positive
feedback from the Company's growing customer base of over 350 clients worldwide, successfully deterring substance abuse at work
and ensuring employee well-being and compliance with health and safety policies.
Intelligent Bio Solutions Inc.
Bio Solutions Inc. (the "Company") (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. This hygienic, and cost-effective
system is designed to screen for recent use of drugs commonly found in the workplace, including opioids, 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. Additionally, the Company's biosensor platform has the potential to test for up to 130 indications,
ranging from glucose to immunological conditions and communicable diseases. The Company's current customer segments include construction,
manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners.
more information, visit http://www.ibs.inc/
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, which involve risks and uncertainties.
Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.'s ability to successfully
develop and commercialize drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure
regulatory approvals (including from the United States Food and Drug Administration), among others. Although Intelligent Bio Solutions
Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may
prove to have been materially different from the results expressed or implied by such forward looking 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," "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, included in Intelligent Bio Solutions' public
filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of
its date. 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.
Pinto, Managing Director
Strategic Communications