Qualtech provides an AI-powered platform that unifies risk management across Engineering and Operations by automating FMEAs and predicting manufacturing failures. The system connects disparate systems like Jira and ERPs to create a single source of truth for organizational risk. This results in continuous compliance monitoring, automated documentation, and reduced liability exposure for regulated industries.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device manufacturers often struggle with inefficient and incomplete risk analysis and quality documentation processes, relying on manual methods and disconnected systems. This can lead to overlooked failure modes, increased audit risks, and delays in bringing safe, high-quality products to market.
Solution
Qualtech AI's Synclytics platform provides an AI-powered solution for risk management and quality documentation in the medtech industry. Synclytics uses AI to generate, link, and synchronize risk and quality documents, such as FMEAs, PHAs, and QCPs, within a centralized workspace. The platform identifies significantly more potential hazards than manual reviews and automatically suggests updates across the QMS/PLM when changes occur. By streamlining documentation and improving risk coverage, Synclytics helps manufacturers accelerate approvals, reduce audit findings, and ensure compliance.
Target Audience
The primary target audience includes enterprise medtech OEMs and contract manufacturers seeking to improve their risk management processes, accelerate regulatory approvals, and ensure the safety and quality of their medical devices.
Features
- AI-powered risk file creation for FMEAs, PHAs, and other quality documents
- Automated identification of failure modes, causes, and effects, uncovering twice the risks compared to manual analysis
- Self-updating documents with instant change propagation across the QMS/PLM
- Centralized workspace compatible with existing QMS/PLM systems, eliminating the need for system replacement or re-validation
- Analytics and audit-readiness features that flag inconsistencies and provide clear metrics on risk status