The ISO 13485 certification is the global standard for quality management systems within the medical device industry. To become certified, companies must demonstrate that important components are designed and manufactured in accordance with stringent regulatory standards.
“We are thrilled to receive the ISO 13485 certification for our quality management system. It is an important milestone in our journey to revolutionize stroke care and reflects our desire to deliver innovative, safe, and high-quality robotic solutions that make a real difference in patient outcomes,” said Matt Curran, Co-Project Lead of Project Nanoflex and CEO of Nanoflex Robotics AG.