ISO 13485 Certification Awarded to Nanoflex Robotics

Nanoflex Robotics AG has received 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 ischemic stroke.
 
“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,” Nanoflex Robotics CEO Matt Curran said.
 
The company is developing a compact remote robotics system that utilizes 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.
 
Nanoflex Robotics is building next-generation remote robotic surgical solutions and devices to enhance access to life-saving procedures. The Nanoflex Robotics platform’s first target application is to enable remote mechanical thrombectomies in acute ischemic stroke patients, where timely intervention is critical. The company’s advanced magnetic navigation technology and ultra-flexible endoluminal robotic tools aim to give physicians greater control and dexterity over procedures, allowing for safer and more precise interventions that enhance patient care, reduce complications, and improve overall outcomes. Additionally, the platform is being developed to facilitate various other procedures that can be executed comfortably and conveniently by in-person physicians. The platform’s compact and mobile design enables seamless integration into diverse clinical settings and operating rooms, underscoring its versatility as a robotic assistant tailored for hospital environments.