ra-qm-skills

alirezarezvani/claude-skills · .gemini/skills/ra-qm-skills/SKILL.md

Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act').

Data & AIMIT★ 25441⑂ 3598commit 19392f7

Install skillView source on GitHub

What this skill does

Regulatory Affairs & Quality Management Skills — Router

This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained.

Routing table

Match the request, then load ra-qm-team/skills/<skill>/SKILL.md. If multiple rows match, ask one clarifying question first.

| Request signals | Skill | Path | |---|---|---| | Regulatory strategy, pathway selection, submissions planning | regulatory-affairs-head | skills/regulatory-affairs-head/ | | Management review, quality KPIs, QMR governance | quality-manager-qmr | skills/quality-manager-qmr/ | | ISO 13485 QMS implementation, process control | quality-manager-qms-iso13485 | skills/quality-manager-qms-iso13485/ | | ISO 14971 risk analysis, FMEA, risk files | risk-management-specialist | skills/risk-management-specialist/ | | Root cause analysis, corrective/preventive actions | capa-officer | skills/capa-officer/ | | Document control, 21 CFR Part 11, DHF/DMR/DHR | quality-documentation-manager | skills/quality-documentation-manager/ | | ISO 13485 internal audits, NC classification | qms-audit-expert | skills/qms-audit-expert/ | | ISO 27001 audit planning and execution | isms-audit-expert | skills/isms-audit-expert/ | | ISMS design, security risk assessment | information-security-manager-iso27001 | skills/information-security-manager-iso27001/ | | EU MDR classification, technical files, PSUR | mdr-745-specialist | skills/mdr-745-specialist/ | | FDA 510(k)/PMA/De Novo, QMSR | fda-consultant-specialist | skills/fda-consultant-specialist/ | | GDPR/DSGVO, DPIA, data subject rights | gdpr-dsgvo-expert | skills/gdpr-dsgvo-expert/ | | EU AI Act risk classification, obligations | eu-ai-act-specialist | skills/eu-ai-act-specialist/ | | ISO/IEC 42001 AI management system | iso42001-specialist | skills/iso42001-specialist/ | | SOC 2 Type I/II readiness, trust criteria | soc2-compliance | skills/soc2-compliance/ |

Quick start

# Example: route a risk-analysis request
cat ra-qm-team/skills/risk-management-specialist/SKILL.md
python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help

Rules

Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.
All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.
Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).

Installation

Copy a source-pinned command for your client. You run it yourself.

Destination: .claude/skills/ra-qm-skills · pinned to the source commit

# Run from your project root
git clone https://github.com/alirezarezvani/claude-skills.git .skillboard-tmp
git -C .skillboard-tmp checkout 19392f7a08264ed00486a251f5b2098321771f94
mkdir -p ".claude/skills"
cp -r ".skillboard-tmp/.gemini/skills/ra-qm-skills" ".claude/skills/"
rm -rf .skillboard-tmp

Review the source before running. This copies files into your project; it is not a one-click install and does not verify runtime safety.

New here? Step-by-step setup – from installing the agent to using the skill

Operating systemAgentI already use Claude Code

1
Install Git
Install Git with your package manager (Debian/Ubuntu shown; use dnf/pacman on others). Official download.
```
sudo apt update && sudo apt install -y git
```
2
Install Claude Code
Requires Node.js 18+. Install the CLI globally: Official docs. (command-line tool)
```
npm install -g @anthropic-ai/claude-code
```

Get the skill, pinned to its exact version

Open a terminal and run these steps (they clone the source, check out the exact commit, and copy the skill into place):

# Run from your project root
git clone https://github.com/alirezarezvani/claude-skills.git .skillboard-tmp
git -C .skillboard-tmp checkout 19392f7a08264ed00486a251f5b2098321771f94
mkdir -p ".claude/skills"
cp -r ".skillboard-tmp/.gemini/skills/ra-qm-skills" ".claude/skills/"
rm -rf .skillboard-tmp

Destination: .claude/skills/ra-qm-skills

4
Use it in Claude Code
Open Claude Code in your project. It reads skills from the folder above, so ra-qm-skills is now available. Always review the source before using it – static checks cannot prove runtime safety.

Security & Audits

Scanner static-checks@0.1.0 · commit 19392f7a0826. Static checks cannot prove runtime safety – review the source and the exact diff before installing. How checks work.

No static rules matched. This is not a safety guarantee.

ra-qm-skills

alirezarezvani/claude-skills · .gemini/skills/ra-qm-skills/SKILL.md

Data & AIMIT★ 25441⑂ 3598commit 19392f7

Install skillView source on GitHub

What this skill does

Regulatory Affairs & Quality Management Skills — Router

This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained.

Routing table

Match the request, then load ra-qm-team/skills/<skill>/SKILL.md. If multiple rows match, ask one clarifying question first.

Quick start

# Example: route a risk-analysis request
cat ra-qm-team/skills/risk-management-specialist/SKILL.md
python3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help

Rules

Route to exactly one skill, then follow that skill's workflow. This router ships no tools of its own.
All outputs are decision support: final compliance determinations route to the named human owner (QMR, DPO, regulatory counsel) — never auto-decide.
Verify regulatory citations against the current text (e.g., FDA QMSR effective 2026-02-02 replaced the legacy QSR subsections).

Installation

Copy a source-pinned command for your client. You run it yourself.

Destination: .claude/skills/ra-qm-skills · pinned to the source commit

# Run from your project root
git clone https://github.com/alirezarezvani/claude-skills.git .skillboard-tmp
git -C .skillboard-tmp checkout 19392f7a08264ed00486a251f5b2098321771f94
mkdir -p ".claude/skills"
cp -r ".skillboard-tmp/.gemini/skills/ra-qm-skills" ".claude/skills/"
rm -rf .skillboard-tmp

Review the source before running. This copies files into your project; it is not a one-click install and does not verify runtime safety.

New here? Step-by-step setup – from installing the agent to using the skill

Operating systemAgentI already use Claude Code

1
Install Git
Install Git with your package manager (Debian/Ubuntu shown; use dnf/pacman on others). Official download.
```
sudo apt update && sudo apt install -y git
```
2
Install Claude Code
Requires Node.js 18+. Install the CLI globally: Official docs. (command-line tool)
```
npm install -g @anthropic-ai/claude-code
```

Get the skill, pinned to its exact version

Open a terminal and run these steps (they clone the source, check out the exact commit, and copy the skill into place):

# Run from your project root
git clone https://github.com/alirezarezvani/claude-skills.git .skillboard-tmp
git -C .skillboard-tmp checkout 19392f7a08264ed00486a251f5b2098321771f94
mkdir -p ".claude/skills"
cp -r ".skillboard-tmp/.gemini/skills/ra-qm-skills" ".claude/skills/"
rm -rf .skillboard-tmp

Destination: .claude/skills/ra-qm-skills

4
Use it in Claude Code
Open Claude Code in your project. It reads skills from the folder above, so ra-qm-skills is now available. Always review the source before using it – static checks cannot prove runtime safety.

Security & Audits

Scanner static-checks@0.1.0 · commit 19392f7a0826. Static checks cannot prove runtime safety – review the source and the exact diff before installing. How checks work.

No static rules matched. This is not a safety guarantee.

ra-qm-skills

What this skill does

Regulatory Affairs & Quality Management Skills — Router

Routing table

Quick start

Rules

Installation

Install Git

Install Claude Code

Get the skill, pinned to its exact version

Use it in Claude Code

Security & Audits

ra-qm-skills

What this skill does

Regulatory Affairs & Quality Management Skills — Router

Routing table

Quick start

Rules

Installation

Install Git

Install Claude Code

Get the skill, pinned to its exact version

Use it in Claude Code

Security & Audits