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.