QualiVerse_AI

QualiVerse is an AI-enabled SaaS platform that Automates, Accelerates and De-risks New Product FDA submissions for Clearance and Approvals. Medical device companies frequently fail to obtain initial FDA approval for new complex medical devices by up to 75% with initial regulatory submissions. The average total spend on FDA-related activities for the product approval process is $24M; these high failure rates significantly contribute to these expenses. These factors delay product development and extend timelines 2-6 years before commercialization and revenue. QualiVerse utilizes generative AI, Large Language Models, and a proprietary database to develop regulatory submission strategies and plans for life science companies focused on developing new products for FDA submissions. QualiVerse is being developed by QMB, Inc. a respected consulting firm in the RA/QA space.