CE MDR Technical Documentation Generator

Problem

Medical device technical documentation often fails at evidence organization rather than missing evidence: what EU MDR Annex II, Annex III, ISO 14971, and CER require, and how reviewers trace claims to evidence, is hard to keep in one loose file set. This skill helps manufacturers and regulatory engineers turn product registration documentation into a review-ready scaffold, reducing late-stage structural gaps.

How It Works

The core capability is generating a structured technical documentation template:
- Collects product name, intended use, device class, software/sterilization/drug involvement, and equivalence information;
- Produces the Annex II seven-module structure and an itemized GSPR checklist, with proof method and evidence location;
- Generates ISO 14971 nine-section risk management report structure, CER template, and EU MDR / FDA 510(k) / NMPA mapping table;
- Adds writing rules: one file per topic, evidence for every claim, tables over prose, version and date control.

Boundaries

It produces a documentation framework and checklist structure, not a final registration conclusion. Product-specific risks, clinical data, test reports, labels, and claims must still be filled in by the manufacturer; for software, sterilization, active measurement, or higher-risk classes, additional evidence for GSPR 10.X, GSPR 11.X, and related clauses is required.