What problem does it solve? Writing medical device technical documentation separately for each market (EU MDR, US FDA, China NMPA, Japan) causes duplicated effort and inconsistent evidence chains. This Skill provides a unified IMDRF STED six-chapter skeleton with cross-market mapping tables so one core document can be reused across jurisdictions. ## Core Features & Use Cases - STED Six-Chapter Skeleton: Structures technical documentation around device description, labeling, design and manufacturing, safety principles, risk analysis, and verification/validation. - Cross-Market Mapping Tables: Aligns STED chapters with EU MDR Annex II/III, US 510(k) Summary/eSTAR (21 CFR 807.92), China 121/122 announcements (eRPS modules), and Japan technical documentation. - Writing Guidance & Official Portals: Per-chapter drafting points plus direct links to official sources (FDA, EUR-Lex, CMDE, PMDA, IMDRF), all flagged for version verification. - Use Case: A regulatory affairs specialist preparing a device for China, EU, and US markets asks how to avoid writing three separate dossiers, and receives a single STED-based skeleton with market-specific supplements (GSPR checklist for EU, SE argumentation and Summary for US, eRPS modules for China). ## Quick Start Ask how to structure one reusable technical file for NMPA, MDR, and FDA submissions and specify your target markets and device class.
