← everything it can do · compliance

Ra Qm Skills TEXT

Acts as a routing index that maps user compliance requests to one of 15 specific regulatory and quality management skills (e.g., ISO 13485, EU MDR, GDPR) within the plugin. It identifies the correct sub-skill to load based on keywords and context without performing the compliance work itself.

2 uses this weeksource alirezarezvanilicence MIT

Quality gate: FAIL · better answers · measured 2026-10-24
Blind-judged against the bare model on 2 requests: average lift -7.5 points (specificity, structure, method, fit).
won 0/2, lift -7.5, tokens ×7.62

Security scan: clean · 2026-10-24 · 1 files · ran in sandbox
no network calls, shell tricks, credential access or instruction tampering found in its files.

Try asking

Say it in your own words; the assistant finds this recipe by itself. Examples:

“Hvilken skill skal jeg bruge til at håndtere vores risikostyring ifølge ISO 14971?”

“Vi skal til audit, men jeg ved ikke om det er ISO 13485 eller MDR. Kan du hjælpe mig med at vælge den rigtige?”

“Hvor finder jeg den skill, der håndterer GDPR og DPIA'er?”

“I need to prepare for an audit, but I'm not sure if it falls under ISO 27001 or ISO 13485. Which skill should I use?”

“We are launching a new AI feature in the EU. Is this high-risk under the AI Act, and which specialist handles that?”

“Can you route me to the right skill for managing our document control and DHF files?”

Try this skill from Claude, ChatGPT or a chat on your own page. Free plan, no credit card.Get started free

Good for

routingcomplianceregulatoryquality-managementiso-13485mdrgdprai-actindex

Not for

Do not use this skill if the user has already specified the exact framework and standard (e.g., 'run an ISO 14971 FMEA'), as the specific specialist skill should be loaded directly. It is not for executing compliance tasks, generating documents, or performing calculations; it is strictly for navigation and selection.

Details

When it is the right choice

Use this skill when a user asks a broad or ambiguous compliance question that could apply to multiple frameworks (e.g., 'how do I handle risk for my medical device?'). It is the entry point for selecting the correct specialized skill from the 15 available options in the bundle. It is also used when the user explicitly asks which specific regulatory skill to use for a given task.

The full recipe the assistant reads

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).

Files in this skill (2)

LICENSE
SKILL.md

Where it comes from

Vendored from alirezarezvani/claude-skills, commit 27cfcd0fb0a4, path ra-qm-team/skills/ra-qm-skills, licence MIT. The upstream licence file ships inside the skill.