ra-qm-skills
CommunityMaster HealthTech Regs & Quality
AuthorFantasia1999
Version1.0.0
Installs0
System Documentation
What problem does it solve?
This comprehensive Skill set addresses the complex and ever-evolving regulatory and quality management challenges faced by HealthTech and MedTech companies, ensuring compliance and accelerating market access.
Core Features & Use Cases
- End-to-End Compliance: Covers the full spectrum from strategic regulatory planning and FDA/EU submissions to QMS implementation (ISO 13485), risk management (ISO 14971), cybersecurity (ISO 27001), and data privacy (GDPR).
- Expert Guidance & Automation: Provides detailed guidance through
SKILL.mdfiles and automates critical tasks with Python scripts for compliance checks, reporting, and analysis. - Use Case: A startup developing a new AI-powered diagnostic device can use this Skill to define its regulatory pathway for both the US (FDA 510(k)) and EU (MDR Class IIb), implement an ISO 13485 QMS, conduct a thorough risk assessment, and prepare the necessary technical documentation and clinical evaluation reports.
Quick Start
Use the ra-qm-skills to generate a regulatory strategy for a new AI diagnostic device targeting the US and EU markets.
Dependency Matrix
Required Modules
None requiredComponents
scriptsreferences
💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: ra-qm-skills Download link: https://github.com/Fantasia1999/claude-skills-zh/archive/main.zip#ra-qm-skills Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
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