Mdr 745 Specialist
alirezarezvani/claude-skills/ra-qm-team/skills/mdr-745-specialistby alirezarezvani19392f7a0826No license27K starsListed Oct 8, 2026Updated Oct 8, 2026Repository updated 5 weeks ago
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').
- 19392f7a0826Currentcommit 19392f7Published Oct 8, 2026
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