About us

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.

Website
https://www.qualiverse.com/
Industry
Software Development
Company size
2-10 employees
Type
Privately Held
Founded
2023
Specialties
RA/QA, 510K submissions, Artificial Intelligence, Life Sciences, Combination Products, Medical Devices, Pharma, PMA, QMS, Machine Learning, and Drug Delivery

Employees at QualiVerse_AI

Updates

Similar pages