firefrost-gaming/claude-skills-reference

Files

Reza Rezvani 670930c69d feat(docs): implement unified design system across all generated pages

- Add CSS components: .page-meta badges, .domain-header, .install-banner
- Fix invisible tab navigation (explicit color for light/dark modes)
- Rewrite generate-docs.py with design system templates
- Domain indexes: centered headers with icons, install banners, grid cards
- Skill pages: pill badges (domain, skill ID, source), install commands
- Agent/command pages: type badges with domain icons
- Regenerate all 210 pages (180 skills + 15 agents + 15 commands)

Co-Authored-By: Claude Opus 4.6 <noreply@anthropic.com>

2026-03-11 12:32:49 +01:00

2.4 KiB

Raw Blame History

title, description

title	description
Regulatory Affairs & Quality Management Skills	Regulatory Affairs & Quality Management Skills - Claude Code skill from the Regulatory & Quality domain.

Regulatory Affairs & Quality Management Skills

:material-shield-check-outline: Regulatory & Quality :material-identifier: `ra-qm-team` :material-github: Source

Install: claude /plugin install ra-qm-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

2.4 KiB Raw Blame History