ValidateML offers an AI‑powered co‑pilot called Regulatory Expert that turns natural‑language queries about MDR, the AI Act, and FDA regulations into structured, audit‑ready reports. The platform hierarchically organizes answers by regulatory binding force, provides exact citations and page references, and delivers consultant‑level accuracy in minutes, helping MedTech compliance teams make risk‑based decisions faster.
Funding
Funding not disclosed
Founders
Product
Problem
MedTech professionals spend extensive time manually searching through fragmented regulatory documents, PDFs, and expert opinions to answer compliance questions, leading to delays and potential errors in product approval.
Solution
Regulatory Expert is an AI‑powered co‑pilot that transforms natural‑language queries about the MDR, AI Act, and FDA regulations into structured, audit‑ready reports. The system interprets the regulatory hierarchy, distinguishing mandatory requirements from best‑practice guidance, and provides each statement with direct citations and page references from the original source documents. This eliminates manual research, reduces turnaround time from days to minutes, and ensures traceable, consultant‑level accuracy for risk‑based decision making.
Target Audience
Primary users are regulatory affairs teams, compliance officers, and product development managers within medical device and health‑tech companies who need fast, reliable answers to European MDR, AI Act, and FDA requirements.
Features
- Hierarchical analysis that organizes answers by regulatory binding force, from laws (Level 1) to whitepapers (Level 4), clarifying mandatory versus advisory content
- Automatic generation of fully cited reports with exact quotations and page numbers, guaranteeing 100 % traceability and audit safety
- Natural‑language query interface that understands complex regulatory questions without requiring keyword‑based searches
- AI engine that maps inter‑regulatory relationships, keeping users up‑to‑date with evolving frameworks such as the AI Act
- Exportable, structured reports ready for inclusion in compliance dossiers and internal reviews