Nanoflex Robotics AG, a remote robotic surgical company based in Switzerland, has received the internationally recognised ISO 13485 certification for its quality management system in designing and manufacturing remote robotic devices for endovascular interventions.
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.
The certification represents Nanoflex Robotics’ commitment to upholding high standards throughout its entire operational chain, from the initial phases of research and development to design and manufacturing. It is a step forward in bringing to market innovative remote robotic solutions that are designed to increase access to critical care procedures, such as the treatment of acute ischaemic stroke.
"We are thrilled to receive the ISO 13485 certification for our quality management system. It is an important milestone in our journey to revolutionise 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, CEO of Nanoflex Robotics.
Nanoflex Robotics’ first product will be a compact remote robotics system that utilises a control unit and magnetism to guide ultra-flexible devices through the body for a range of complex interventions. The company aims to make remote mechanical thrombectomies a reality through remote robotics surgery, thereby shortening the time to treatment and preserving the quality of life for stroke patients.
