Head of Regulatory Affairs — Documentation

This skill provides comprehensive regulatory affairs expertise for medical device companies, guiding users through FDA 510(k), De Novo, and PMA submissions, EU MDR CE marking, global market access strategies, and regulatory intelligence. It produces structured regulatory strategy documents, submission checklists, and decision frameworks.

ra-qm claude-code

📂 View skill on GitHub ↗ 🚀 How to use

✨ What it does

Provides step-by-step workflows for regulatory strategy, FDA submissions, EU MDR, and global market access
Includes decision matrices for pathway selection (510(k) vs De Novo vs PMA) and market prioritization
Offers templates for regulatory strategy documents and GSPR checklists
Lists common FDA deficiencies and prevention strategies
Covers Notified Body selection criteria and clinical evidence requirements by class
Includes regulatory intelligence and change management guidance

🎯 When to use it

Planning or executing FDA 510(k), De Novo, or PMA submissions
Navigating EU MDR CE marking and Notified Body interactions
Developing regulatory strategy for new medical devices
Coordinating multi-market approval strategies across FDA, EU, and other regions
Responding to FDA deficiency letters or Notified Body queries

🚀 How to use

Trigger the skill by asking for regulatory strategy, FDA submission planning, EU MDR CE marking, or global market access guidance. Provide product details such as intended use, device classification, technology, and target markets. The skill will guide you through the appropriate workflow and produce a strategy document or submission checklist.

Example prompts:

Help me develop a regulatory strategy for a novel AI-based wound imaging software targeting the US and EU.

I need to prepare a 510(k) submission for a new surgical stapler. What are the steps?

📄 Output: The skill produces regulatory strategy documents, submission checklists, and decision frameworks tailored to the user's product and target markets.

📦 Add this skill to Claude Code

# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills

# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/regulatory-affairs-head .claude/skills/regulatory-affairs-head

Skill source: ra-qm-team/skills/regulatory-affairs-head/SKILL.md

⚠️ Good to know

The skill provides guidance based on general regulatory knowledge but does not guarantee regulatory approval; users should verify current regulations and consult with official agencies or Notified Bodies.

❓ FAQ

What is the difference between a 510(k) and a De Novo submission?

A 510(k) is for devices with a predicate, while De Novo is for novel low-to-moderate risk devices without a predicate. The skill includes a comparison matrix.

What are the clinical evidence requirements for a Class IIb device under EU MDR?

Class IIb devices require a clinical evaluation report with clinical data, plus a post-market clinical follow-up (PMCF) plan, and may require a clinical study.

How do I choose a Notified Body?

Consider scope, capacity, experience, geography, cost, and communication. The skill provides a selection criteria list.

🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.