Intelligent Bio Solutions Obtains ISO Recertification for its Intelligent Fingerprinting Drug Screening Business
27 Setembro 2023 - 9:30AM
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.
ISO 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.
“Receiving 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.”
The 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.
The 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.
About Intelligent Bio Solutions
Inc.
Intelligent 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.
For more information,
visit http://www.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, 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.
Company Contact:Intelligent Bio Solutions
Inc.info@ibs.incInvestor Contact:Valter Pinto,
Managing DirectorKCSA Strategic CommunicationsPH: (212)
896-1254INBS@kcsa.com
Media Contact:Cheryl BillsonComma
Communications+44 (0)7791 720460cheryl.billson@commacomms.com
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