mdr-745-specialist
CommunityEU MDR 2017/745 compliance expert and consultant.
Legal & Compliance#conformity assessment#MDR 2017/745#clinical evaluation#UDI#EU MDR#Notified Body#post-market surveillance
Authorovachiever
Version1.0.0
Installs0
System Documentation
What problem does it solve?
Senior MDR compliance specialist providing gap analysis, Annex II/III documentation guidance, clinical evidence planning, and PMCF/post-market surveillance strategies.
Core Features & Use Cases
- MDR classification and risk assessment guidance
- Annex II & III technical documentation structuring
- Clinical evaluation strategies and PMCF planning
- UDI strategy and EUDAMED considerations
- Notified Body engagement and audit readiness
Quick Start
Begin with a high-level MDR gap analysis of a device, then draft the Annex II technical documentation outline.
Dependency Matrix
Required Modules
None requiredComponents
scriptsreferencesassets
💻 Claude Code Installation
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Please help me install this Skill: Name: mdr-745-specialist Download link: https://github.com/ovachiever/droid-tings/archive/main.zip#mdr-745-specialist Please download this .zip file, extract it, and install it in the .claude/skills/ directory.