What is the mdr-745-specialist skill?

It is a specialized capability for Claude Code designed to assist medical device professionals in navigating and documenting compliance with the European Medical Device Regulation (EU MDR 2017/745).

Does it include automation for regulatory tasks?

Yes, it features specialized Python scripts for automated gap assessments, clinical evidence tracking, and UDI/EUDAMED compliance verification.

Does it help with Technical Documentation?

Absolutely. It provides templates and structures for Annex II and III technical files, covering design, manufacturing, and General Safety and Performance Requirements (GSPR).

Can this skill classify my medical device?

Yes, it applies MDR Annex VIII classification rules and MDCG guidance to provide preliminary classification assessments and justifications for Class I, IIa, IIb, and III devices.

How does it handle Post-Market Surveillance?

The skill includes frameworks for PMS plans, Periodic Safety Update Reports (PSUR), and Post-Market Clinical Follow-up (PMCF) to ensure continuous regulatory compliance.

MDR 2017/745 Compliance Specialist

Name: MDR 2017/745 Compliance Specialist
Author: pur3v4d3r

bypur3v4d3r

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学習とドキュメンテーション

Guides medical device manufacturers through EU MDR 2017/745 compliance requirements, technical documentation, and regulatory submissions.

概要

The mdr-745-specialist skill transforms Claude into a senior regulatory consultant specialized in the European Medical Device Regulation (EU MDR 2017/745). It provides expert-level guidance on device classification, technical file preparation per Annex II and III, clinical evidence strategy, and post-market surveillance (PMS) implementation. By leveraging domain-specific scripts and templates, this skill helps teams conduct systematic gap analyses, manage UDI system requirements, and prepare for Notified Body audits, ensuring that medical device documentation meets rigorous safety and performance standards.

主な機能

Technical documentation structuring for Annex II and III files
Clinical evidence strategy and PMCF planning per Annex XIV
1 GitHub stars
UDI system implementation and EUDAMED registration support
Automated MDR compliance gap assessment and transition planning
Expert device classification per Annex VIII and MDCG guidance

ユースケース

Developing a Post-Market Surveillance (PMS) plan and Periodic Safety Update Reports
Drafting and organizing Technical Files for Notified Body submission
Performing a gap analysis on legacy medical device documentation for MDR transition

概要

主な機能

Technical documentation structuring for Annex II and III files
Clinical evidence strategy and PMCF planning per Annex XIV
1 GitHub stars
UDI system implementation and EUDAMED registration support
Automated MDR compliance gap assessment and transition planning
Expert device classification per Annex VIII and MDCG guidance

ユースケース

Developing a Post-Market Surveillance (PMS) plan and Periodic Safety Update Reports
Drafting and organizing Technical Files for Notified Body submission
Performing a gap analysis on legacy medical device documentation for MDR transition