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. This is an important milestone toward the commercialization of the company’s first product, the Airo® Mobile Computed Tomography (CT) System, a one-of-a-kind imaging system.
“Achieving ISO certification was a priority since the company’s inception. Our goal was not only to comply with all FDA guidance and regulations, but also to go a step beyond. We view this accomplishment as significant progress toward meeting the demand for Mobius Imaging products and recognize the importance of the ISO standard in marketing Mobius products internationally,” explained Gene Gregerson CEO of Mobius Imaging.
The company harnesses what it calls Intelligent Imaging to develop novel products that are engineered specifically to acclimate into different care environments intuitively to further enable quality care. With its Airo Mobile CT System, Mobius has taken advantage of breakthrough technologies and provides practitioners the flexibility to achieve high quality imaging easily throughout the hospital.
“Our decision to become ISO certified was fueled by our passion for providing our customers with the very best products and services in the medical imaging industry,” states Gregerson. “Mobius’ certification to this standard further validates that our products are manufactured at the highest level of quality control.”