Does it cover software as a medical device (SaMD)?

Absolutely. It includes specific patterns for software classification and maps documentation requirements to IEC 62304 standards.

What documentation templates are included?

The skill provides structures for GSPR compliance matrices, Clinical Evaluation Reports (CER), PMCF plans, and Periodic Safety Update Reports (PSUR).

Can it help prepare for a Notified Body audit?

Yes, it provides comprehensive pre-submission checklists and ensures technical documentation meets the specific requirements of Annex II and III.

How does this skill help with medical device classification?

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

MDR 745 Compliance Specialist

Name: MDR 745 Compliance Specialist
Author: oabdelmaksoud

byoabdelmaksoud

0•

Learning & Documentation

Guides medical device development teams through EU MDR 2017/745 compliance requirements, classification, and technical documentation.

This skill serves as a domain-specific expert for medical device manufacturers navigating the European Union Medical Device Regulation (MDR 2017/745). It provides structured workflows for device classification under Annex VIII, detailed technical file preparation per Annex II/III, clinical evaluation reporting (Annex XIV), and post-market surveillance planning. It is an essential tool for regulatory affairs professionals and engineers needing to ensure GSPR compliance, EUDAMED integration, and UDI implementation while preparing for Notified Body audits.

Key Features

01Post-market surveillance (PMS) and vigilance reporting framework generation

02Clinical evidence strategy and Clinical Evaluation Report (CER) drafting guidance

03Technical documentation structuring for Annex II and III compliance files

04Automated device classification using Annex VIII rules and MDCG 2019-11 software algorithms

050 GitHub stars

06EUDAMED registration and UDI system implementation checklists

Use Cases

01Drafting a General Safety and Performance Requirements (GSPR) compliance matrix

02Classifying a new AI-based diagnostic software under MDR Rule 11 and MDCG guidelines

03Developing a Post-Market Clinical Follow-up (PMCF) plan for high-risk implantable devices

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

Key Features

01Post-market surveillance (PMS) and vigilance reporting framework generation

02Clinical evidence strategy and Clinical Evaluation Report (CER) drafting guidance

03Technical documentation structuring for Annex II and III compliance files

04Automated device classification using Annex VIII rules and MDCG 2019-11 software algorithms

050 GitHub stars

06EUDAMED registration and UDI system implementation checklists

Use Cases

01Drafting a General Safety and Performance Requirements (GSPR) compliance matrix

02Classifying a new AI-based diagnostic software under MDR Rule 11 and MDCG guidelines

03Developing a Post-Market Clinical Follow-up (PMCF) plan for high-risk implantable devices

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