QMB provides an AI‑driven regulatory intelligence platform for MedTech companies, helping them accelerate new product development and FDA submissions. The solution combines regulatory expertise with machine learning to generate product codes, predicate device analyses, and design planning documents, reducing submission preparation time by up to 80% and improving approval success rates.
Funding
$750K raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
MedTech companies often face lengthy, manual regulatory processes that delay product development and FDA submissions, leading to increased costs and missed market opportunities.
Solution
QMB offers an AI‑driven regulatory intelligence platform that automates the generation of product codes, predicate device analyses, and FDA‑ready design documentation. Its QualiVerse® engine rapidly evaluates a device, identifies the appropriate regulatory pathway, flags potential risks, and produces compliant submission materials within minutes. The platform integrates expert‑in‑the‑loop review to ensure accuracy and regulatory confidence. By combining machine learning with embedded regulatory expertise, QMB reduces submission preparation time by up to 80% and improves approval success rates to around 95%, turning compliance into a strategic advantage for MedTech innovators.
Target Audience
Primary customers are MedTech founders, regulatory affairs (RA) and quality assurance (QA) teams, and product development groups that need faster, reliable FDA submission preparation.
Features
- AI‑native QualiVerse® engine that analyzes devices, selects correct product codes, and identifies predicate devices in minutes
- Automated generation of FDA‑ready design history files, risk analyses, and other submission documentation
- Expert‑in‑the‑loop review workflow that validates AI outputs for regulatory accuracy
- Real‑time risk visibility and regulatory pathway recommendations to guide new product development
- Cloud‑based SaaS platform delivering scalable, on‑demand access for regulatory, quality, and development teams
- Integration of explainable AI (XAI) to provide transparent rationale for each recommendation