ac845cf476
Root cause: CLI tools (ai-agent-skills, agent-skills-cli) look for SKILL.md at the specified install path. 7 of 9 domain directories were missing this file, causing "Skill not found" errors for bundle installs like: npx ai-agent-skills install alirezarezvani/claude-skills/engineering-team Fix: - Add root-level SKILL.md with YAML frontmatter to 7 domains - Add .codex/instructions.md to 8 domains (for Codex CLI discovery) - Update INSTALLATION.md with accurate skill counts (53→170) - Add troubleshooting entry for "Skill not found" error All 9 domains now have: SKILL.md + .codex/instructions.md + plugin.json Closes #301 Co-Authored-By: Claude Opus 4.6 <noreply@anthropic.com>
67 lines
2.3 KiB
Markdown
67 lines
2.3 KiB
Markdown
---
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name: "ra-qm-skills"
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description: "12 production-ready regulatory affairs and quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO compliance, risk management (ISO 14971), CAPA, document control, and internal auditing. Python tools included (all stdlib-only). Works with Claude Code, Codex CLI, and OpenClaw."
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version: 1.0.0
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author: Alireza Rezvani
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license: MIT
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tags:
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- regulatory
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- quality-management
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- iso-13485
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- mdr
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- fda
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- iso-27001
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- gdpr
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agents:
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- claude-code
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- codex-cli
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- openclaw
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---
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# Regulatory Affairs & Quality Management Skills
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12 production-ready compliance skills for HealthTech and MedTech organizations.
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## Quick Start
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### Claude Code
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```
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/read ra-qm-team/regulatory-affairs-head/SKILL.md
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```
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### Codex CLI
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```bash
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npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team
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```
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## Skills Overview
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| Skill | Folder | Focus |
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|-------|--------|-------|
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| Regulatory Affairs Head | `regulatory-affairs-head/` | FDA/MDR strategy, submissions |
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| Quality Manager (QMR) | `quality-manager-qmr/` | QMS governance, management review |
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| Quality Manager (ISO 13485) | `quality-manager-qms-iso13485/` | QMS implementation, doc control |
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| Risk Management Specialist | `risk-management-specialist/` | ISO 14971, FMEA, risk files |
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| CAPA Officer | `capa-officer/` | Root cause analysis, corrective actions |
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| Quality Documentation Manager | `quality-documentation-manager/` | Document control, 21 CFR Part 11 |
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| QMS Audit Expert | `qms-audit-expert/` | ISO 13485 internal audits |
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| ISMS Audit Expert | `isms-audit-expert/` | ISO 27001 security audits |
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| Information Security Manager | `information-security-manager-iso27001/` | ISMS implementation |
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| MDR 745 Specialist | `mdr-745-specialist/` | EU MDR classification, CE marking |
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| FDA Consultant | `fda-consultant-specialist/` | 510(k), PMA, QSR compliance |
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| GDPR/DSGVO Expert | `gdpr-dsgvo-expert/` | Privacy compliance, DPIA |
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## Python Tools
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17 scripts, all stdlib-only:
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```bash
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python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
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python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help
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```
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## Rules
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- Load only the specific skill SKILL.md you need
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- Always verify compliance outputs against current regulations
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