The startup provides a RegTech platform that utilizes cloud computing, AI/ML, and data science to enhance the quality of governmental data for medical device manufacturers and regulatory professionals. It addresses the need for rapid insights and compliance support in post-market surveillance and health hazard evaluations, enabling efficient data exploration and audit-ready reporting.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device manufacturers and regulatory professionals face challenges in efficiently extracting insights from governmental data for post-market surveillance and health hazard evaluations. The volume and complexity of this data make it difficult to rapidly identify critical trends and ensure compliance.
Solution
This startup offers a RegTech platform that leverages cloud computing, AI/ML, and data science to enhance the quality and accessibility of governmental data. The platform automates the scrubbing and harmonization of massive datasets within Google Cloud, enabling users to extract actionable insights and improve compliance. By providing tools for risk analysis, medical device code understanding, and audit-ready reporting, the platform facilitates data-driven decision-making and streamlines regulatory processes. The platform helps connect the dots by automating FDA compliance in native cloud applications.
Target Audience
The primary target audience includes medical device manufacturers and regulatory professionals involved in post-market surveillance, risk management, and regulatory compliance.
Features
- Cloud-based data scrubbing and harmonization using Google Cloud native tools
- Risk quadrant analysis for identifying and bracketing potential risks
- Medical device code analysis to understand real-world evidence and IMDRF code applications
- Customizable application for comparing different devices
- Drill-down metrics for in-depth data analysis
- Audit-ready report generation for compliance purposes