iso-13485-certification
Offers a toolkit for ISO 13485 compliance, including gap analysis and documentation generation for medical device quality standards.
Install
mkdir -p .claude/skills/iso-13485-certification && curl -L -o skill.zip "https://agentskills.codes/api/skills/download/5864" && unzip -o skill.zip -d .claude/skills/iso-13485-certification && rm skill.zipInstalls to .claude/skills/iso-13485-certification
Activation
This is the description your AI agent reads to decide when to run this skill — the better it matches your request, the more reliably it fires.
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.Key capabilities
- →Conduct gap analysis of existing QMS documentation
- →Generate Quality Manuals from templates
- →Develop required procedures and work instructions
- →Identify missing documentation for certification
- →Provide clause-by-clause ISO 13485 requirements guidance
How it works
The skill uses a Python script to scan documentation directories against ISO 13485 requirements and provides templates for missing mandatory documents.
Inputs & outputs
When to use iso-13485-certification
- →Conducting gap analysis
- →Writing QMS documentation
- →Preparing for certification audits
About iso-13485-certification
Provides a guided toolkit for ISO 13485 compliance. It supports gap analysis of existing documentation and content generation for medical device quality standards.
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
When not to use it
- →When seeking legal advice for medical device regulatory filings
- →When performing actual physical audits of manufacturing facilities
Prerequisites
Limitations
- →Requires manual customization of templates to match specific organizational operations
- →Does not replace the need for professional regulatory audit certification
How it compares
Unlike manual compliance tracking, this tool automates the gap analysis process and provides pre-structured templates for all 31 required procedures.
Compared to similar skills
iso-13485-certification side by side with the closest alternatives in the catalog.
| Skill | Installs | Updated | Safety | Difficulty |
|---|---|---|---|---|
| iso-13485-certification (this skill) | 1 | 2mo | Review | Intermediate |
| legal-advisor | 11 | 4mo | No flags | Intermediate |
| quality-documentation-manager | 3 | 7mo | Review | Advanced |
| softcopyright | 1 | 8mo | Review | Beginner |
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