Ayer, Mass. (December 10, 2013) – Mobius Imaging®, LLC, announced today that it has received ISO 13485 Certification for its quality management system. This achievement represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It demonstrates a commitment from management for quality throughout the product development lifecycle and the product’s lifespan with customers.
Check back often for the latest news on Mobius Imaging.
Airo Size and Flexibility Suitable for Wide Range of Intraoperative Imaging Options
Chicago, Illinois, October 9, 2013 – Brainlab, a leading software technology company with a longstanding dedication to innovation in the fields of neuro- and spinal surgery, announced today the 510(k) clearance from the US Food and Drug Administration (FDA) to market Airo® Mobile Intraoperative CT in the US. The FDA clearance was received by Mobius Imaging®, LLC the developer and manufacturer of Airo Mobile Intraoperative CT on September 26, 2013.