What problem does it solve? Preparing CE marking technical documentation under EU MDR 2017/745 requires assembling Annex II/III structures, GSPR compliance checklists, ISO 14971 risk management files, and clinical evaluation reports, which is slow and error-prone when done manually. ## Core Features & Use Cases - Technical Documentation Generation: Produces the seven-module MDR Annex II structure, 5-column GSPR checklists aligned with TEAM-NB expectations, and ISO 14971 risk management templates. - 2026 Regulatory Coverage: Integrates EUDAMED mandatory registration (2026-05-28), EU AI Act 2024/1689 high-risk AI obligations, MDR Annex I §17.2 cybersecurity, and MDCG 2026-4 SSCP upload duties. - Gap Analysis Script: Runs mdr_gap_analyzer.py to assess compliance gaps by device class and output prioritized recommendations in text or JSON. - Use Case: A manufacturer preparing a Class IIb device submission asks for a complete technical documentation skeleton with GSPR checklist, CER structure, and EUDAMED registration data requirements. ## Quick Start Ask the assistant to generate an MDR Annex II technical documentation framework with a GSPR checklist and CER structure for your device, providing its name, classification, and intended purpose.
