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Navigate the demanding regulatory landscape with...
AI-native, prescriptive planning for regulatory submissions, minimizes risk and maintains compliance within your organization...
At QMB, we are creating an industry-first SaaS solution utilizing native AI to guide MedTech and BioTech companies through the regulatory environment. Our objective is to accelerate their new product development to achieve regulatory clearances and approvals while simultaneously driving internal quality compliance.
Users will be able to customize parameters for product-specific submissions and will be guided through all the relevant output to execute a successful regulatory and compliance strategy.
We are currently engaging medtech industry partners (who focus on infusion pump systems and drug delivery) for future beta testing on QualiVerse. Please contact us for more information and let us know if you would like to be a part of our pilot program.
Automate
Remove the highly manual process of conducting research and developing a regulatory strategy
Accelerate
We accelerate the process by generating 10,000+ necessary pages of documentation for submission and review
De-risk
Our AI functions with our proprietary algorithms to identify risks and issues before regulatory product submission
Can QualiVerse® and QMB help your organization achieve greater success with your FDA and EMA product submissions? Do you want to move faster than your competitor in strategizing your regulatory pathway? Please use the form below to contact us to find out how we can improve your internal RA QA capabilities.
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