ra-qm-skills
CommunityMaster HealthTech compliance effortlessly.
Authorzhangzhang-111-i
Version1.0.0
Installs0
System Documentation
What problem does it solve?
Navigating the complex landscape of HealthTech and MedTech regulations (ISO 13485, MDR, FDA, etc.) is challenging and time-consuming. This Skill collection provides expert guidance and automation tools to ensure compliance, accelerate market access, and maintain quality standards.
Core Features & Use Cases
- End-to-End Compliance: Covers all major regulatory frameworks from QMS implementation to post-market surveillance.
- Automated Workflows: Utilizes Python scripts for tasks like risk analysis, compliance checking, and audit scheduling.
- Use Case: A startup developing a new medical device can use the
regulatory-affairs-headskill to plan its FDA submission strategy, then leverage therisk-management-specialistskill to perform an FMEA analysis, and finally use thequality-manager-qms-iso13485skill to ensure their QMS meets ISO 13485 requirements.
Quick Start
Use the regulatory-affairs-head skill to plan the FDA submission strategy for a new medical device.
Dependency Matrix
Required Modules
None requiredComponents
scriptsreferences
💻 Claude Code Installation
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Please help me install this Skill: Name: ra-qm-skills Download link: https://github.com/zhangzhang-111-i/claude-skills111/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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