B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation.

Abstract

B-onic Suite is an integrated platform that combines surgical planning, personalized medical device development, and intraoperative navigation within a regulatory-compliant workflow. Leveraging patient-specific imaging, the system enables the creation of customized anatomical models, surgical guides, and implants through ISO 13485-certified 3D printing processes. Unlike existing commercial solutions, B-onic Suite ensures end-to-end traceability and compliance with MDR and FDA regulations, bridgi