Mdr 745 Specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').
Works with: Claude Code, Cursor, Codex CLI
Category: Security — see all ranked ›
Work: Regulatory compliance
Who it is for: Legal / compliance · Security engineer
- Adoption: 1 repos
- Health: active
- GitHub stars: 23,181
- Contributors: 30
- License: MIT
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source ↗ · skill:alirezarezvani/mdr-745-specialist
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