ClinTrace

ClinTrace is a web app (with optional desktop agent) that continuously captures, structures, and packages regulatory evidence for AI-enabled medical devices. It connects to your ML pipeline and QMS docs to auto-generate an “evidence ledger” for each model version: training data lineage, preprocessing steps, validation results, risk controls, human factors notes, and post-market monitoring signals. It then maps artifacts to key expectations (FDA, EU MDR, ISO 13485/14971, IEC 62304) and produces exportable review packets for internal audits and submissions. This is an AI + traditional app: AI helps classify documents, detect missing evidence, and draft traceability narratives, but the system is designed to be verifiable and reviewer-friendly (no black-box claims). Realistically, success depends on tight integrations and trust—so the MVP should focus on one pipeline (e.g., MLflow) and one doc system (e.g., SharePoint) to prove value quickly.