Quality Management System Developed for CT Technology

Quality management software designed for computed tomography (CT) systems has received ISO 13485 certification.

This is a major move toward the marketing of the company’s first product, the Airo Mobile CT system, a unique imaging system. “Achieving ISO certification was a priority since the company’s inception. Our goal was not only to comply with all FDA [US Food and Drug Administration] 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, LLC (Ayer, MA, USA).

The company utilizes 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 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,” stated Mr. Gregerson. “Mobius’ certification to this standard further validates that our products are manufactured at the highest level of quality control.”

Mobius Imaging develops and manufactures advanced imaging technologies that fit seamlessly into existing medical workflows. The company’s approach to technology, Intelligent Imaging, is designed to give healthcare practitioners the clear images without adding time or complexity to the procedure. Its first commercial product, the Airo Mobile CT system, is distributed under an exclusive sales and service agreement with Brainlab.

Related Links:
Mobius Imaging
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