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regulatory-affairs-head

Guide medical device regulatory submissions across FDA, EU MDR, and international markets.

2|Updated Mar 13, 2026
Search Tags:#medical device#submission#EU MDR#FDA#regulatory affairs#CE marking#market access
One-click install
npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill regulatory-affairs-head-zhangzhang-111-i
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: regulatory-affairs-head
Source: https://github.com/zhangzhang-111-i/claude-skills111/tree/main/ra-qm-team/regulatory-affairs-head
Command: npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill regulatory-affairs-head-zhangzhang-111-i

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

This Skill streamlines the complex and time-consuming process of obtaining regulatory approvals for medical devices in key global markets, ensuring compliance and market access.

Core Features & Use Cases

  • Global Submission Strategy: Develop and execute plans for FDA, EU MDR, Health Canada, PMDA, NMPA, and TGA approvals.
  • Documentation Management: Prepare essential regulatory documents like 510(k)s, PMAs, Technical Documentation, and CERs.
  • Use Case: A startup has developed a novel AI-powered diagnostic device and needs to launch in the US and EU within 18 months. This Skill will guide them through the entire FDA 510(k) and EU MDR Technical Documentation process, including identifying the correct regulatory pathways and required evidence.

Quick Start

Use the regulatory-affairs-head skill to plan the FDA submission strategy for a new Class II medical device.

Frequently Asked Questions about regulatory-affairs-head

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I prepare technical documentation for EU MDR CE marking submission?▼

To prepare EU MDR technical documentation for CE marking, you need comprehensive Clinical Evaluation Reports (CERs) and compliance checklists. This Skill provides workflows covering the 2017/745 requirements, decision frameworks, and relevant ISO standards references to streamline your global market access.

What is the best way to determine the correct FDA submission pathway for a new medical device?▼

The best way to determine an FDA submission pathway is using decision frameworks to evaluate 510(k), PMA, or De Novo routes based on device classification. This Skill guides you through identifying the correct regulatory pathways and the required evidence for US market access.

Can I use this to plan regulatory approvals for both US and EU markets simultaneously?▼

Yes, you can plan regulatory approvals for US and EU markets simultaneously. The Skill supports global submission strategy development, guiding you through FDA requirements and EU MDR technical documentation concurrently to ensure compliance and efficient market access.

How do I navigate medical device market access requirements for Canada, Japan, and China?▼

To navigate medical device market access in Canada, Japan, and China, you need specific international regulatory requirements for Health Canada, PMDA, and NMPA. This Skill provides targeted workflows and guidance for these regions alongside FDA and EU MDR frameworks.

What ISO standards and regulatory guidance documents do I need for a Class II medical device 510(k) submission?▼

For a Class II medical device 510(k) submission, you need references to relevant ISO standards and regulatory guidance documents. This Skill includes checklists and references to ensure your FDA submission strategy meets all required evidence and documentation benchmarks.

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