ModelDossier

ModelDossier is a web app (with optional desktop agent) that helps AI-enabled medical device teams assemble regulatory-grade evidence packages without living in spreadsheets and shared drives. It ingests artifacts from GitHub, Jira, cloud storage, and QMS exports, then maps them to a configurable evidence checklist aligned to IEC 62304, ISO 13485, ISO 14971, and FDA expectations for SaMD/ML. The AI layer suggests missing evidence, flags traceability gaps (e.g., requirement → risk control → test → release), and generates “audit packets” with immutable snapshots and a clear change history. It does not pretend to auto-approve compliance; it accelerates preparation and consistency while keeping humans in control. The product is brutally focused on one outcome: faster, less painful audits and submissions with fewer last-minute surprises.