Ra Qm Skills

alirezarezvani/claude-skills/ra-qm-team/skills/ra-qm-skills

by alirezarezvani19392f7a0826MIT27K starsListed Oct 8, 2026Updated Oct 8, 2026Repository updated 5 weeks ago

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').

Instructions onlyBusiness & Finance

AI-generated overview

Routes compliance requests to one of 15 bundled regulatory and quality-management skills.

What it does: This is a router/index skill for a plugin bundling 15 regulatory affairs and quality management skills covering areas such as ISO 13485, EU MDR, FDA submissions, ISO 14971 risk, CAPA, document control, ISO 27001, ISO 42001, the EU AI Act, GDPR, SOC 2 and auditing. It provides a routing table that matches request signals to a specific skill and its path, and instructs loading that skill's SKILL.md. It ships no tools of its own and produces a routing decision rather than compliance artifacts.
When to use it: Use it when a compliance request does not obviously match a single bundled skill and you need to pick the right one, for example preparing for an ISO 13485 audit or assessing whether an AI system is high-risk under the AI Act. It is also useful when several routing rows match and one clarifying question is needed first.
Requirements: No scripts or tools of its own; it requires access to the bundled skill folders and their SKILL.md files. Outputs are decision support, with final compliance determinations routed to a named human owner.

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

bash

# Example: route a risk-analysis requestcat ra-qm-team/skills/risk-management-specialist/SKILL.mdpython3 ra-qm-team/skills/risk-management-specialist/scripts/risk_matrix_calculator.py --help

# Example: route a risk-analysis requestcat ra-qm-team/skills/risk-management-specialist/SKILL.mdpython3 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).

Source and attribution

Source:alirezarezvani/claude-skillsinra-qm-team/skills/ra-qm-skillsat commit19392f7

License: MIT

Content belongs to its original authors. SourceWeft indexes it from a public repository.

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Ra Qm Skills

Regulatory Affairs & Quality Management Skills — Router

Routing table

Quick start

Rules

Source and attribution

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