Individual skill
mdr-745-specialist
Use for EU MDR 2017/745 work: device classification under Annex VIII, technical file gaps (Annex II/III), clinical evaluation, PMS and PSUR cadence, notified body prep. Checks the file with mdr_gap_analyzer.py.
ra-qm-team/skills/mdr-745-specialist/SKILL.md
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SKILL.mdcore · 10,102 bytesSKILL.mdcore · 10,102 bytesreferences/clinical-evidence-requirements.mddoc · 9,408 bytesreferences/mdr-classification-guide.mddoc · 8,948 bytesreferences/technical-documentation-templates.mddoc · 10,364 bytesscripts/mdr_gap_analyzer.pyruns · 18,171 bytes
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# MDR 2017/745 Specialist
EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.
---
## Table of Contents
- [Device Classification Workflow](#device-classification-workflow)
- [Technical Documentation](#technical-documentation)
- [Clinical Evidence](#clinical-evidence)
- [Post-Market Surveillance](#post-market-surveillance)
- [EUDAMED and UDI](#eudamed-and-udi)
- [Reference Documentation](#reference-documentation)