ra-qm-skills
Skill115 starsChanged 6 months agoMITView on GitHub
12 skills e plugins de agentes para Assuntos Regulatórios e Gestão da Qualidade no Claude Code. Cobre ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, LGPD/DSGVO, gestão de riscos (ISO 14971), CAPA, controle de documentos e auditoria — para o mercado brasileiro e internacional. Python tools (somente stdlib).
14 other projects use a version of this, 12 of them edited.
Adopted by
Most recently taken up by
- DinakarDbx/claude-skillsedited, first seen Oct 15, 2026
- hmzainjamil/claude-skillsedited, first seen Oct 9, 2026
- Hassaan146/claude-skillstheir own version, first seen Jul 25, 2026
- mahiunfiltered/claude-code-skillstheir own version, first seen Jul 8, 2026
- Hussain-Elfalah/Agentic-Skillsedited, first seen Jun 4, 2026
- krishna7671/Claude-skillsedited, first seen May 7, 2026
Other versions14 projects use a version of this.
Word for word · 0
None found.
Edited · 12
- ArogyaReddy/alirezarezvani-claude-skills★ 3129% same
- zhangzhang-111-i/claude-skills111★ 328% same
- afaizalam2003/Master-claude-skill★ 229% same
- Hussain-Elfalah/Agentic-Skills★ 227% same
- emiiblesstm-star/claude-skills★ 129% same
- benmoumene/claude-skills★ 029% same
- DinakarDbx/claude-skills★ 029% same
- hmzainjamil/claude-skills★ 029% same
- jsgm0918/claude-skills★ 029% same
- krishna7671/Claude-skills★ 027% same
2 more not listed
Wrote their own version · 2
- Hassaan146/claude-skills★ 18same name
- mahiunfiltered/claude-code-skills★ 1same name
How matches are found. Word for word: the exact same text. Edited: shares passages with this file (“99% same” means 99% of its five-word phrases also appear here; 10% or more counts). Their own version: similar meaning, or, weakest, the same name. We can’t tell which project had it first. Projects are counted among the 200 most-starred candidates, and mentions are links to the repository we found, up to 50 per site, so both counts are a floor.
In this repository29 other files it gives its agents.
- CLAUDE.mdCLAUDE.md
- accessibilitySkill
- bash-defensive-patternsSkill
- frontend-designSkill
- seoSkill
- business-growth-skillsSkill
- carreira-educacaoSkill
- c-level-advisorSkill
- codigo-automacaoSkill
- conteudo-copySkill
- design-brandingSkill
- direcao-criativaSkill
- engineering-advanced-skillsSkill
- engineering-skillsSkill
- financeiro-complianceSkill
- finance-skillsSkill
- juridico-advocaciaSkill
- lideranca-equipesSkill
- marketing-skillsSkill
- marketing-vendasSkill
- operacoes-rhSkill
- prd-generatorSkill
- product-skillsSkill
- produto-ecommerceSkill
- pm-skillsSkill
- rotina-organizacaoSkill
- sdd-generatorSkill
- seguranca-mvsSkill
- seo-analiticaSkill
The file
Files
Skills de Assuntos Regulatórios & Gestão da Qualidade
12 skills de conformidade prontas para produção em organizações HealthTech e MedTech.
Início Rápido
Claude Code
/read ra-qm-team/regulatory-affairs-head/SKILL.mdVisão Geral das Skills
| Skill | Pasta | Foco |
| Regulatory Affairs Head | regulatory-affairs-head/ | Estratégia FDA/MDR, submissões |
| Quality Manager (QMR) | quality-manager-qmr/ | Governança do QMS, revisão gerencial |
| Quality Manager (ISO 13485) | quality-manager-qms-iso13485/ | Implementação do QMS, controle de documentos |
| Risk Management Specialist | risk-management-specialist/ | ISO 14971, FMEA, arquivos de risco |
| CAPA Officer | capa-officer/ | Análise de causa raiz, ações corretivas |
| Quality Documentation Manager | quality-documentation-manager/ | Controle de documentos, 21 CFR Part 11 |
| QMS Audit Expert | qms-audit-expert/ | Auditorias internas ISO 13485 |
| ISMS Audit Expert | isms-audit-expert/ | Auditoria de segurança ISO 27001 |
| Information Security Manager | information-security-manager-iso27001/ | Implementação do ISMS |
| MDR 745 Specialist | mdr-745-specialist/ | Classificação EU MDR, marcação CE |
| FDA Consultant | fda-consultant-specialist/ | 510(k), PMA, conformidade QSR |
| LGPD/GDPR/DSGVO Expert | gdpr-dsgvo-expert/ | Conformidade de privacidade, DPIA |
Python Tools
17 scripts, todos somente stdlib:
python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --helpRegras
- Carregue apenas o SKILL.md da skill específica que você precisa
- Sempre verifique os resultados de conformidade em relação às regulamentações vigentes
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