QMB QualiVerse_AI is proud to be a Platinum Sponsor for the upcoming CAPRA - Canadian Association of Professionals in Regulatory Affairs Pharmaceutical Symposium this October. We look forward to engaging industry leaders and regulatory colleagues at this event! Michel E. Moravia, MBA, MSE Henry Kim Leonard Glatkowski Tanima Ghosh
关于我们
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.
- 网站
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https://www.qualiverse.com/
QualiVerse_AI的外部链接
- 所属行业
- 软件开发
- 规模
- 2-10 人
- 类型
- 私人持股
- 创立
- 2023
- 领域
- RA/QA、510K submissions、Artificial Intelligence、Life Sciences、Combination Products、Medical Devices、Pharma、PMA、QMS、Machine Learning和Drug Delivery
QualiVerse_AI员工
动态
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Chief Executive Officer at Quality Means Business | 40 under 40 | GenAI Expert | Life Science Quality & Regulatory Leader
Here's a strong frameworks for adopting Generative AI in Healthcare/ Life Science in a Safe and Responsible manner. A systems approach (SBOM or AIOps) for demonstrating control will likely prove to be game-changer. Thanks Bakul Patel at Google Health for your exemplary insights. #generativeai #responsibleai #safeai #lifescience #medtech #biotech #aiops #mlops #trainingdata #pccp #trainingplans #knowkedgegraphs #llms #validation #fda
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"The AI assessment aid works with electronic health records to digest 22 pieces of clinical information and biomarkers before assigning a patient to one of four risk levels linked to the possibility of developing sepsis complications." https://lnkd.in/gHe2J_-i
Roche picks up Prenosis' newly cleared sepsis AI tool for distribution
fiercebiotech.com
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QMB will present its SaaS platform QualiVerse at “Imagination in Action.” Founded by John Werner, this event is being held at MIT and features some of the most exciting and promising AI startups emerging today. QMB and QualiVerse are immensely proud to participate in this event next week on April 18th! Michel E. Moravia, MSE, MBA Christopher Wallace Henry Kim Leonard Glatkowski Quality Means Business
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"...the most frequent adverse events were from continuous glucose monitors.?Those data were so large that they dwarfed everything else.?" https://lnkd.in/gNWEMY6e
Unpacking Averages: Adverse Events for Device-Lead Combination Products
natlawreview.com