ra-qm-skills

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').

Ir para a instalação

Repositório: alirezarezvani/claude-skills
Última atividade na origem: 11 de junho de 2026 às 03:58
Idioma detectado do SKILL.md: inglês
Estrelas: 24.525
Forks: 3.442

Opções de instalação

Por padrão, está selecionado o prompt que primeiro revisa a origem. Você pode mudar para um comando direto ou baixar uma cópia local.

Instalar com Codex ou Claude Copie este prompt, cole no Codex, Claude ou outro assistente e deixe que ele revise a página da skill e instale para você.

Um comando direto ignora o prompt de revisão. Verifique a origem antes de executá-lo.

npx skills add https://github.com/alirezarezvani/claude-skills --skill ra-qm-skills

O comando permanece em uma só linha. Role horizontalmente para revisá-lo antes de copiar.

Prefere uma cópia local? Baixe os arquivos disponíveis atualmente no SkillsMP.

Revise os arquivos de origem

Leia o SKILL.md e os arquivos complementares exibidos pelo SkillsMP antes de decidir se vai instalar.

SKILL.md

Instruções da origem · Visualização somente leitura

Voltar à pesquisa Voltar à instalação

meetings

Use when someone wants to decide whether a meeting is worth calling, price a meeting in dollars, build a timeboxed agenda with desired outcomes, or turn messy meeting notes into owned action items — or says "should this be a meeting", "/cs:meeting-prep", or "/cs:meeting-actions". Runs a cost gate (ASYNC / NOT-READY / MEET), builds a decision-first agenda, and extracts an owner + due-date checklist that flags every orphan.

2026-07-17

deep-work

Use when someone wants to plan a deep work day, time-block their calendar or task list, budget or cut shallow work, protect focus hours, track deep-work sessions and streaks, run an end-of-day shutdown ritual, or says "/deep-work" or "/time-block". Classifies tasks deep vs shallow, builds an energy-first time-blocked schedule that refuses deep demand past the 4-hour ceiling, batches shallow work into at most two windows, and logs focus sessions against a weekly target.

2026-07-17

agent-harness

Turn any domain folder of skills into a bounded agentic loop: compile a goal into a verifiable task plan, execute tasks with the domain's own tools, verify every task with machine-run checks, retry with caps, escalate to a human when budgets exhaust, and refuse to close until everything is verified or explicitly waived. Use when you want an agent or subagent to pick up a goal and drive it to a verified close across one of this repo's 18 domains ('run this goal through the engineering harness', 'set up an agentic loop for marketing work', 'make the finance domain self-verifying'). NOT for authoring Claude Code Workflow-tool .js scripts (workflow-builder), N-agent tournaments on one task (agenthub), single-file metric optimization (autoresearch-agent), or discovering published loop recipes (loop-library).

2026-07-17

Ver todas deste repositório

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).

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).

name	ra-qm-skills
description	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').
version	2.9.0
author	Alireza Rezvani
license	MIT
tags	["regulatory","quality-management","iso-13485","mdr","fda","iso-27001","gdpr"]
agents	["claude-code","codex-cli","openclaw"]

name	ra-qm-skills
description	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').
version	2.9.0
author	Alireza Rezvani
license	MIT
tags	["regulatory","quality-management","iso-13485","mdr","fda","iso-27001","gdpr"]
agents	["claude-code","codex-cli","openclaw"]

ra-qm-skills

Informações da origem

Opções de instalação

Revise os arquivos de origem

Mais deste repositório

Mais deste repositório

Regulatory Affairs & Quality Management Skills — Router

Routing table

Quick start

Rules

Regulatory Affairs & Quality Management Skills — Router

Routing table

Quick start

Rules