The Notified Bodies

Vigil is an AI-powered post-market surveillance workflow for medical device incident reports. Medical device companies receive complaints, adverse event reports, and field feedback in messy, unstructured formats. Turning these into regulatory-ready actions is slow, repetitive, and high-risk because teams need to understand the incident, classify its severity, decide whether it is reportable, prepare documentation, plan investigations, and define corrective actions. Vigil helps automate the first pass of this process. It reads an incoming incident report, extracts the key facts, categorizes the event, identifies missing information, drafts a structured regulatory report, proposes an investigation plan, and suggests follow-up actions. The system keeps a human in the loop, so a responsible person can review, edit, and approve the final output before anything is submitted. The goal is not to replace regulatory experts, but to give them a faster, more consistent, and auditable workflow for medical device vigilance and post-market surveillance.