RegProofKit

RegProofKit is a web app (with optional desktop agent) that automatically assembles regulatory evidence for AI-enabled medical devices. It ingests model training metadata, dataset lineage, risk management artifacts, software change logs, and clinical evaluation references, then maps them to common expectations for FDA, EU MDR, and ISO 13485/14971 documentation. The AI layer drafts traceability narratives and highlights missing evidence, but the system is designed to be reviewer-led: every claim is linked to a source file, hash, and timestamp. It outputs “audit packs” (PDF + structured folder) with consistent naming, versioning, and cross-references, reducing the scramble before submissions and surveillance audits. It also supports supplier evidence collection (e.g., cloud hosting, data labeling vendors) via secure requests and immutable receipts. This is not a magic compliance button; it’s a practical evidence assembly line.