How does this skill help with medical device classification?

It applies MDR Annex VIII rules and MDCG 2019-11 algorithms to help determine the correct device class (I, IIa, IIb, or III) based on duration, invasiveness, and specific risk factors.

Can it assist with Software as a Medical Device (SaMD)?

Absolutely. It contains specific logic for software classification per Rule 11 and covers GSPR 17 requirements specifically for medical software development.

Does this cover post-market requirements?

Yes, it details the requirements for Post-Market Surveillance (PMS) plans, Periodic Safety Update Reports (PSUR), and clinical follow-up (PMCF) activities.

Does this skill provide templates for technical documentation?

Yes, it includes structured templates for Annex II and III technical documentation, including GSPR matrices, benefit-risk analysis, and Design History File (DHF) structures.

What is the included MDR Gap Analyzer tool?

The Gap Analyzer is a command-line utility that assesses your device against MDR requirements to identify compliance gaps and provide prioritized remediation recommendations.

EU MDR Compliance Specialist

Name: EU MDR Compliance Specialist
Author: oabdelmaksoud

byoabdelmaksoud

0•

生産性とワークフロー

Guides medical device development through EU MDR 2017/745 compliance requirements, from classification and technical documentation to EUDAMED registration.

The MDR 745 Specialist skill provides expert-level guidance for navigating the complex European Union Medical Device Regulation. It assists regulatory affairs (RA) and quality management (QM) teams in accurately classifying devices under Annex VIII, drafting technical documentation per Annex II and III, and managing clinical evaluation reports (CER). By offering structured workflows for post-market surveillance (PMS), UDI implementation, and EUDAMED integration, this skill ensures that developers and manufacturers maintain high safety standards while accelerating the path to Notified Body approval and European market access.

主な機能

01Post-market surveillance (PMS) and vigilance reporting workflow automation

02GSPR (General Safety and Performance Requirements) compliance checklists

03Comprehensive technical documentation templates for Annex II and III compliance

04Clinical evidence framework and Clinical Evaluation Report (CER) structuring

05Automated device classification using Annex VIII and MDCG 2019-11 logic

060 GitHub stars

ユースケース

01Performing a regulatory gap analysis for existing devices transitioning to MDR

02Classifying medical software or hardware under MDR risk rules (I, IIa, IIb, III)

03Preparing structured technical files and GSPR matrices for Notified Body submission

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add oabdelmaksoud/superclaw mdr-745-specialist

For use in Claude.ai and ChatGPT

主な機能

01Post-market surveillance (PMS) and vigilance reporting workflow automation

02GSPR (General Safety and Performance Requirements) compliance checklists

03Comprehensive technical documentation templates for Annex II and III compliance

04Clinical evidence framework and Clinical Evaluation Report (CER) structuring

05Automated device classification using Annex VIII and MDCG 2019-11 logic

060 GitHub stars

ユースケース

01Performing a regulatory gap analysis for existing devices transitioning to MDR

02Classifying medical software or hardware under MDR risk rules (I, IIa, IIb, III)

03Preparing structured technical files and GSPR matrices for Notified Body submission