Inquisito provides an AI‑driven platform that automates the 510(k) submission workflow for life‑science companies, covering predicate device research, eSTAR document generation, and compliance validation. The system offers intelligent predicate search that synthesizes FDA guidance and precedent data, and it produces complete eSTAR drafts—including device descriptions, indications for use, and substantial equivalence analyses—while a built‑in FDA Acceptance Checklist flags missing information to help ensure regulatory approval.
Funding
Funding not disclosed
Founders
Product
Problem
Life‑science manufacturers face a time‑consuming, fragmented process for 510(k) submissions, requiring manual research of predicate devices, drafting of extensive eSTAR documents, and meticulous compliance checks to meet FDA requirements.
Solution
Inquisito offers an AI‑driven platform that consolidates predicate research, eSTAR document generation, and compliance validation into a single workflow. The system uses natural‑language processing to locate and analyze relevant predicate devices, FDA guidance, and prior 510(k) submissions, then automatically drafts device descriptions, indications for use, and substantial equivalence analyses. Built‑in FDA Acceptance Checklist validation flags missing or non‑conforming data before submission. By automating these steps, Inquisito reduces the effort and turnaround time needed to achieve FDA clearance while maintaining regulatory accuracy.
Target Audience
Primary customers are medical device manufacturers and regulatory affairs teams that need to prepare and submit 510(k) applications efficiently.
Features
- Intelligent predicate search that scans FDA databases and prior 510(k) filings to identify comparable devices and relevant guidance
- AI‑assisted eSTAR generation producing complete draft documents, including device description, indications for use, and substantial equivalence analysis
- Automated compliance validation with an FDA Acceptance Checklist that highlights missing or non‑compliant elements
- Integrated workflow that links research, drafting, and verification, eliminating the need for separate tools
- Cloud‑based platform with secure data handling to protect proprietary device information