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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>
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name, description, version, author, license, tags, agents
| name | description | version | author | license | tags | agents | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ra-qm-skills | 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. | 1.0.0 | Alireza Rezvani | MIT |
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Regulatory Affairs & Quality Management Skills
12 production-ready compliance skills for HealthTech and MedTech organizations.
Quick Start
Claude Code
/read ra-qm-team/regulatory-affairs-head/SKILL.md
Codex CLI
npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team
Skills Overview
| Skill | Folder | Focus |
|---|---|---|
| Regulatory Affairs Head | regulatory-affairs-head/ |
FDA/MDR strategy, submissions |
| Quality Manager (QMR) | quality-manager-qmr/ |
QMS governance, management review |
| Quality Manager (ISO 13485) | quality-manager-qms-iso13485/ |
QMS implementation, doc control |
| Risk Management Specialist | risk-management-specialist/ |
ISO 14971, FMEA, risk files |
| CAPA Officer | capa-officer/ |
Root cause analysis, corrective actions |
| Quality Documentation Manager | quality-documentation-manager/ |
Document control, 21 CFR Part 11 |
| QMS Audit Expert | qms-audit-expert/ |
ISO 13485 internal audits |
| ISMS Audit Expert | isms-audit-expert/ |
ISO 27001 security audits |
| Information Security Manager | information-security-manager-iso27001/ |
ISMS implementation |
| MDR 745 Specialist | mdr-745-specialist/ |
EU MDR classification, CE marking |
| FDA Consultant | fda-consultant-specialist/ |
510(k), PMA, QSR compliance |
| GDPR/DSGVO Expert | gdpr-dsgvo-expert/ |
Privacy compliance, DPIA |
Python Tools
17 scripts, all stdlib-only:
python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help
Rules
- Load only the specific skill SKILL.md you need
- Always verify compliance outputs against current regulations