Veridocx provides an AI‑driven platform that streamlines 510(k) regulatory submissions by automatically generating Substantial Equivalence (SE) matrices. Leveraging a database of over 180,000 FDA‑cleared devices, the tool instantly compares indications, technical specifications, and performance data, linking each point to the original FDA citation for audit‑ready documentation. This reduces research time from weeks to seconds and cuts consulting costs for medical device manufacturers.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device manufacturers face lengthy and costly 510(k) submissions, often requiring 6‑12 months and over $31,000 in consulting fees. The bulk of this effort is spent on manually searching a database of more than 180,000 FDA‑cleared devices, comparing indications, technical characteristics, and performance specifications to identify suitable predicate devices.
Solution
Veridocx offers an automated platform that streamlines the 510(k) preparation process by instantly surfacing the most relevant predicate devices from an up‑to‑date FDA database. The system generates audit‑ready Substantial Equivalence (SE) matrices that compare indications, technology, and performance metrics, with each data point linked to its original FDA citation. By reducing systematic research from months to minutes, the platform eliminates the need for extensive consulting and accelerates time‑to‑market. The output is compatible with the FDA’s eSTAR submission system, ensuring seamless integration into existing regulatory workflows. Veridocx’s evidence‑based approach provides regulatory professionals with transparent, source‑verified documentation rather than opaque AI predictions.
Target Audience
Primary users are medical device manufacturers and in‑house regulatory affairs teams that need to prepare 510(k) submissions efficiently and cost‑effectively.
Features
- Real‑time comparison of indications, technical characteristics, and performance specifications across 180,000+ cleared devices
- Automatic generation of audit‑ready Substantial Equivalence matrices with direct FDA citation links
- Weekly synchronization with FDA data to maintain current product codes and regulatory standards
- eSTAR‑compatible export format for direct inclusion in FDA submissions
- Search filters for product codes, indications, and performance metrics to prioritize strongest predicate matches
- Dashboard that highlights citation sources and evidence hierarchy for regulatory review