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').
Only the file list is public. File contents are available once the skill is installed in a workspace.
| Path | Size | Type |
|---|---|---|
| references/clinical-evidence-requirements.md | 9.2 KB | text/markdown |
| references/mdr-classification-guide.md | 8.7 KB | text/markdown |
| references/technical-documentation-templates.md | 10.1 KB | text/markdown |
| scripts/mdr_gap_analyzer.py | 17.7 KB | text/plain |
| SKILL.md | 10.2 KB | text/markdown |
Source and attribution
Source:alirezarezvani/claude-skillsinra-qm-team/skills/mdr-745-specialistat commit19392f7
License: No license
Content belongs to its original authors. SourceWeft indexes it from a public repository.
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