Exact public version
mdr-745-specialist v1
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').
e6268b72935d313f3f8c40ccb8b3cd3be95d681460076b7e88eb31e3c488167ePackage contents
Manifest
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').
4bc82e8eed1f359d09211b310e89b4aeb312b2d5875e2767ccd6c8ecad11d037- SKILL.md10,438 bytes
- references/clinical-evidence-requirements.md9,408 bytes
- references/mdr-classification-guide.md8,948 bytes
- references/technical-documentation-templates.md10,364 bytes
- scripts/mdr_gap_analyzer.py18,171 bytes