Michael Barbella, Managing Editor09.28.23
Inspira Technologies OXY B.H.N. Ltd. has received International Organization for Standardization (ISO) 13485:2016 certification, the international standard for quality management systems within the medical device industry, and a requirement for EU regulatory approval.
"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." Inspira Technologies CEO Dagi Ben Noon stated.
The ISO certification process encompasses various 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—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 management systems.
Inspira Technologies has developed a breakthrough augmented respiration technology (INSPIRA ART), targeting hyper-personalization care, supported by INSPIRA AI that is designed to rebalance patient oxygen saturation levels within minutes. 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. Inspira Technologies' products have not yet been tested or used in humans and has not been approved by any regulatory entity.
"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." Inspira Technologies CEO Dagi Ben Noon stated.
The ISO certification process encompasses various 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—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 management systems.
Inspira Technologies has developed a breakthrough augmented respiration technology (INSPIRA ART), targeting hyper-personalization care, supported by INSPIRA AI that is designed to rebalance patient oxygen saturation levels within minutes. 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. Inspira Technologies' products have not yet been tested or used in humans and has not been approved by any regulatory entity.