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medical-qms-tools

Plan, review, and gap-assess medical device QMS documentation against ISO 13485 and FDA QMSR.

126|8|Updated Mar 10, 2026
Search Tags:#documentation#regulatory compliance#fda#medical device#qms#iso 13485
One-click install
npx skills add https://github.com/DrugClaw/DrugClaw --skill medical-qms-tools
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: medical-qms-tools
Source: https://github.com/DrugClaw/DrugClaw/tree/main/skills/medical/medical-qms-tools
Command: npx skills add https://github.com/DrugClaw/DrugClaw --skill medical-qms-tools

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve?

This Skill assists users in navigating the complexities of medical device quality management system (QMS) documentation, helping to plan, review, and gap-assess documentation against regulatory standards.

Core Features & Use Cases

  • QMS Gap Assessment: Evaluate existing documentation against ISO 13485 and FDA QMSR.
  • Documentation Planning: Assist in creating or reviewing Quality Manuals, SOPs, CAPAs, and other critical QMS documents.
  • Audit Preparation: Generate checklists for audit readiness.
  • Use Case: A startup developing a new diagnostic device needs to ensure their Quality Manual and design control procedures meet FDA requirements. This Skill can help them map their current documentation to the relevant clauses and identify any gaps.

Quick Start

Use the medical-qms-tools skill to gap-assess our current design control documentation against ISO 13485.

Frequently Asked Questions about medical-qms-tools

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

FAQPage Schema
How do I gap assess medical device QMS documentation against ISO 13485 and FDA QMSR?▼

Structured QMS gap assessment evaluates existing Quality Manuals, SOPs, CAPA, and design control documentation against ISO 13485 and FDA QMSR clauses to identify missing elements and ensure compliance readiness.

What's the best way to plan SOP and CAPA documentation for medical device compliance?▼

Planning SOP and CAPA documentation involves structuring procedures to align with ISO 13485 process requirements, ensuring traceability across quality management records for audit preparation and regulatory compliance.

Can I use this to check if my design control procedures meet FDA QMSR requirements?▼

Yes, you can evaluate design control procedures by mapping current documentation to relevant FDA QMSR clauses, which helps identify specific compliance gaps in your medical device quality management system.

How do I generate an audit readiness checklist for ISO 13485 quality documentation?▼

Generate an audit readiness checklist by reviewing QMS documentation against ISO 13485 standards, verifying that all required Quality Manual clauses, SOPs, and risk management processes are properly documented.

Does this regulatory compliance guidance provide legal guarantees for FDA submissions?▼

No, this regulatory compliance guidance facilitates documentation traceability and audit preparation without providing legal or regulatory guarantees for FDA submissions or medical device approvals.

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