CytoSorbents, a critical care focused therapeutic device company in clinical trials to treat severe sepsis, has achieved ISO 13485:2003 Full Quality Systems certification.
ISO 13485 is an internationally recognised quality standard designed to ensure that medical device manufacturers have the necessary comprehensive management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU).
CytoSorbents chief executive officer Phillip Chan said that they are very pleased to have attained this key milestone.
“Of the possible options, Full Quality Systems certification is the most stringent and efficient route to CE mark approval for CytoSorb and other future CytoSorbents products,” Chan said.
“When coupled with CE mark approval, ISO 13485 certification will allow CytoSorbents to commercialize its products in the EU market and other countries that recognize the ISO 13485 and CE mark standards.”
CytoSorb is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm.
CytoSorb is designed for various medical applications, including improved dialysis, rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others.