Does it include templates for technical documentation?

Yes, the skill provides access to structured templates for Annex II and III technical files, PMS plans, and clinical evaluation reports.

Can it help with Clinical Evaluation Reports (CER)?

Yes, it provides framework guidance for literature-based evidence appraisal and ensures alignment with MEDDEV 2.7/1 rev.4 and Annex XIV requirements.

Can I use this for Software as a Medical Device (SaMD)?

Absolutely, it includes specific modules for software classification and documentation requirements per current MDCG guidance.

How does this skill help with MDR classification?

It applies Annex VIII rules and MDCG 2019-11 software guidance to provide a documented rationale for device classes I, IIa, IIb, and III.

EU MDR 2017/745 Compliance Specialist

Name: EU MDR 2017/745 Compliance Specialist
Author: alirezarezvani

byalirezarezvani

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1,039

학습 및 문서화

Provides expert guidance and automated tools for EU Medical Device Regulation (MDR) compliance, technical documentation, and regulatory strategy.

소개

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 comprehensive support for device classification, Annex II/III technical file preparation, clinical evidence strategy, and post-market surveillance implementation. Designed for regulatory affairs professionals and medical device developers, it streamlines complex compliance tasks through automated gap analysis scripts, standardized templates, and expert interpretation of MDCG guidance to ensure market readiness and continuous safety monitoring.

주요 기능

Structured Technical Documentation (Annex II & III) preparation guidance
Clinical evidence pathway selection and PMCF planning support
UDI system implementation and EUDAMED registration workflows
1,039 GitHub stars
Automated MDR compliance gap analysis and transition planning tools
Expert device classification assessment based on Annex VIII and MDCG rules

사용 사례

Performing a gap analysis for transitioning legacy medical devices to full MDR compliance
Developing a compliant Technical File structure for new Class IIa/IIb medical devices
Creating post-market surveillance plans and Periodic Safety Update Reports (PSUR)

소개

주요 기능

Structured Technical Documentation (Annex II & III) preparation guidance
Clinical evidence pathway selection and PMCF planning support
UDI system implementation and EUDAMED registration workflows
1,039 GitHub stars
Automated MDR compliance gap analysis and transition planning tools
Expert device classification assessment based on Annex VIII and MDCG rules

사용 사례

Performing a gap analysis for transitioning legacy medical devices to full MDR compliance
Developing a compliant Technical File structure for new Class IIa/IIb medical devices
Creating post-market surveillance plans and Periodic Safety Update Reports (PSUR)