How does this skill handle medical device software classification?

The skill applies the MDCG 2019-11 algorithm alongside Annex VIII Rule 11 to determine the correct class (I, IIa, IIb, or III) based on the severity of the condition and the software's role in clinical decisions.

Is this tool a replacement for a Notified Body or RA consultant?

No, this skill is a domain-specific assistant designed to help regulatory professionals prepare and organize documentation. All outputs should be validated by qualified regulatory affairs experts.

Does it include Post-Market Surveillance (PMS) requirements?

It outlines the necessary PMS system components, including Article 84 plans, Periodic Safety Update Report (PSUR) schedules by device class, and serious incident reporting timelines.

Can this skill help generate a Technical File?

Yes, it provides structured templates and checklists for Annex II and III, including GSPR compliance matrices, benefit-risk analysis, and design verification evidence.

EU MDR 2017/745 Compliance Specialist

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

byoabdelmaksoud

0•

学习与文档

Guides medical device compliance under EU MDR 2017/745 regulations, covering classification, technical files, and clinical evaluations.

The MDR 2017/745 Specialist skill is a comprehensive regulatory intelligence layer for medical device development. It assists teams in navigating complex EU market requirements by providing automated classification logic under Annex VIII, structured templates for Annex II/III technical documentation, and frameworks for Clinical Evaluation Reports (CER). Whether you are managing Post-Market Surveillance (PMS), implementing UDI systems for EUDAMED, or preparing for Notified Body audits, this skill ensures your documentation aligns with General Safety and Performance Requirements (GSPR) and the latest MDCG guidance.

主要功能

01Clinical evidence strategy development and CER structure appraisal.

02UDI/EUDAMED implementation checklists for labeling and registration.

03Structured generation of GSPR compliance matrices and technical file headers.

040 GitHub stars

05Automated Annex VIII device classification including MDCG 2019-11 software logic.

06Post-Market Surveillance (PMS) planning and PSUR reporting schedules.

使用场景

01Conducting a comprehensive gap analysis for existing medical device technical files.

02Drafting a clinical evidence plan to address gaps before Notified Body submission.

03Classifying Software as a Medical Device (SaMD) based on clinical risk and intent.

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

主要功能

01Clinical evidence strategy development and CER structure appraisal.

02UDI/EUDAMED implementation checklists for labeling and registration.

03Structured generation of GSPR compliance matrices and technical file headers.

040 GitHub stars

05Automated Annex VIII device classification including MDCG 2019-11 software logic.

06Post-Market Surveillance (PMS) planning and PSUR reporting schedules.

使用场景

01Conducting a comprehensive gap analysis for existing medical device technical files.

02Drafting a clinical evidence plan to address gaps before Notified Body submission.

03Classifying Software as a Medical Device (SaMD) based on clinical risk and intent.