Your regulatory support solution for precision medical devices
AI-First software with extensive domain expertise, QMB seamlessly integrates into your existing workflows to bring drug delivery systems, combination products, to market.
Quality. Value. Profit. Quality. Value. Profit. Quality. Value. Profit. Quality. Value. Profit. Quality. Quality. Value. Profit. Quality. Value. Profit. Quality. Value. Profit. Quality. Value. Profit. Quality. Value. Profit.
QMB reduces the time to market through AI-first smart actions and expert consultant support
without QMB
4 year
Average development time
with QMB
1 year
Reduction in development time
without QMB
75%
Average failure rate
with QMB
10%
De-risked rejection rate
without QMB
$24 mil
Average approval cost
with QMB
$13 mil
Average savings
Transforming quality and regulatory business units from cost centers to profit drivers
QualiVerse ™, our cloud-native, SaaS solution is driven by:
Real-World Evidence
Insights are drawn directly from actual patient experiences and outcomes in real-world settings.
Embedded Domain Experience
Backed by live QA/RA Experts fine-tuning the user experience and outcome.
AI-First Technology
Primarily focused on data and algorithm-based architecture, and trained on real-world data and global regulation adherence.
Features
A peek into the product
Discover some of the features and functionalities of the product
Regulatory Strategy Recommendations
Qualiverse is a trusted companion that meets regulatory requirements by providing strategic direction via critical-to-quality initiatives.
Risk Traceability Matrix
Our AI/ML solution ensures risk mitigation management and audit readiness by surveying your tech stack and comparing against product specific requirements/regulations.
DHF Automation
An end-to-end quality solution for all product development phases.
Prescriptive Insights
QualitVerse ™, a quality analytics solution, streamlines and de-risks approval failures for regulatory filings via AI-First assessments and smart actions.
Executive Dashboard
An interactive visual interface, designed to provide a concise, yet detailed view of your product’s development and health in real-time.
Smart Actions
Critical-to-Quality initiatives derived from a comparison between the current state of your product and the associated regulatory requirements. An engine that converts quality cost centers into profit drivers.
QMB Partners
Global Regulatory Impact
QMB is compliant with EUMDR 2017/745, ISO13485:2016, MDSAP 21CFR Part 11, 21CFR PART 820, and ISO 14791 creating a global reach.
“QMB brings innovative frameworks that provide visibility to a complex supply chain that enables QMS and overall quality maturity.”
-Jinghua Huang, VP of QARA at Midsize MedTech Company
QMB is trusted by
