Full Press Release Details
Technologies Receives Certification of Medical Devices Quality Management Systems, Another Step Towards EU Regulatory Approval
Israel, July 24, 2023 - Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or
"Inspira Technologies"), a company aiming to revolutionize acute respiratory care, is proud to announce it has received International
Organization for Standardization (ISO) 13485:2016 Standard Certification, which is the international standard for quality management
systems within the medical device industry, and a requirement for EU regulatory approval.
Ben Noon, Inspira Technologies' Chief Executive Officer, stated: "By successfully obtaining this ISO certification, Inspira
Technologies has demonstrated adherence of our quality management system to the highest standards, which comply with industry best practices".
ISO certification encompasses key aspects, including design, development, manufacturing, distribution and sales of extracorporeal and
blood monitoring devices and respiratory care devices. The ISO certification process also involved a comprehensive evaluation of the
Company's quality management system, including documentation, risk management and continuous improvement practices. The assessment
was conducted by the British Standards Institution Group, an independent, third-party auditing firm specializing in medical device quality
ISO 13485: https://www.iso.org/standard/59752.html
Inspira Technologies OXY B.H.N. Ltd.
Technologies is an innovative medical technology company in the respiratory treatment arena. The Company has developed a breakthrough
Augmented Respiration Technology (INSPIRATM ART), targeting hyper-personalization care, supported by INSPIRA AI that is designed
to rebalance patient oxygen saturation levels within minutes, aiming to significantly improve patient outcomes. This technology potentially
allows patients to remain awake during treatment while reducing the need for highly invasive, risky, and costly mechanical ventilation
systems that require intubation and medically induced coma. The Company's products have not yet been tested or used in humans and
has not been approved by any regulatory entity.
more information, please visit our corporate website: https://inspira-technologies.com