Congratulations to HighLife, a Sofinnova Partners Capital Strategy portfolio company, on the ISO 13485 certification for its Quality Management System. HighLife, is focused on the development of a novel Trans-septal Mitral Valve Replacement (TMVR) system to treat patients suffering from moderate to severe Mitral Regurgitation (MR). This certification indicates that HighLife has successfully established robust policies and procedures paving the way for the regulatory approvals and market introduction of its TMVR technology. Learn more: https://lnkd.in/eeNyzViq Antoine Papiernik #medtech #cardiology
We are proud to announce that we obtained the ISO 13485 certification of our Quality Management System! ISO 13485 is a globally recognized standard that provides the quality management system requirements, essential for medical device reliability, procedure efficacy, and patient safety. This certification aligns with our commitment to the highest standards of quality and providing the best service to the doctors and patients. Read more: https://lnkd.in/epbdUyK5 #ISO13485 #TMVR #MedicalDevices #QualityCertification #Cardiology