Cs Quality Regulatory
Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions, GDPR/DSGVO, and ISMS audits. Orchestrates ra-qm-team skills. Spawn when users need regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation.
- Type
- Subagent
- Repository
- alirezarezvani/claude-skills
- GitHub stars
- 26.6k
- License
- MIT
- Repo last updated
- Aug 30, 2026
- Source file
- agents/ra-qm-team/cs-quality-regulatory.md
- Model
- sonnet
What Cs Quality Regulatory is
Cs Quality Regulatory is a subagent published in the alirezarezvani/claude-skills repository on GitHub, which has about 26.6k stars. The repository describes itself as: “380 Claude Code skills & agent skills & plugins (30+ Agents, 70+ custom commands, 380+ skills, customizable references, scripts)for Claude Code, Codex, Gemini CLI, Cursor, and 8 more coding agents — engineering, marketing, product, compliance, C-level advisory, research, business operations, commercial & finance, and your daily productivity skills.”
A subagent is a specialist assistant that Claude can hand part of a task to. It is a markdown file whose frontmatter sets a name, a description that tells Claude when to delegate, and optionally the tools and model it may use; the body becomes the subagent's own system prompt.
Because a subagent works in its own context, it keeps the main conversation focused: Claude can send a narrow job, such as a review or a specialised analysis, to Cs Quality Regulatory and get back a compact result.
It is set up to use these tools: Read, Write, Bash, Grep, Glob. Limiting tools is a good sign: the subagent can only do what those tools allow.
How to install Cs Quality Regulatory
Claude Code
- Download cs-quality-regulatory.md from the repository.
- Save it to ~/.claude/agents/ to use it in every project, or to .claude/agents/ inside one project to share it through version control.
- Claude Code watches these folders, so the subagent is usually available right away. Ask Claude to use it by name, or @-mention it to make sure it runs.
Claude Cowork
- Cowork loads subagents through plugins. If the repository is packaged as a plugin marketplace, add it under Customize → Plugins → Add marketplace and install the plugin that contains this subagent.
- Otherwise, bundle the file into your own plugin's agents/ folder and upload it from Customize → Plugins.
New to extending Cowork? Our plugins guide and Customize guide explain how skills, plugins, and connectors fit together.
Inside the source file
An excerpt from agents/ra-qm-team/cs-quality-regulatory.md, shared under the repository's MIT license. Read the full file on GitHub.
Role & Expertise
Regulatory affairs and quality management specialist for medical device and healthcare companies. Covers ISO 13485, EU MDR 2017/745, FDA (510(k)/PMA), GDPR/DSGVO, and ISO 27001 ISMS.
Skill Integration
Quality Management
- ra-qm-team/quality-manager-qms-iso13485 — QMS implementation, process management
- ra-qm-team/quality-manager-qmr — Management review, quality metrics
- ra-qm-team/quality-documentation-manager — Document control, SOP management
- ra-qm-team/qms-audit-expert — Internal/external audit preparation
- ra-qm-team/capa-officer — Root cause analysis, corrective actions
Regulatory Affairs
- ra-qm-team/regulatory-affairs-head — Regulatory strategy, submission planning
- ra-qm-team/mdr-745-specialist — EU MDR classification, technical documentation
- ra-qm-team/fda-consultant-specialist — 510(k)/PMA/De Novo pathway guidance
- ra-qm-team/risk-management-specialist — ISO 14971 risk management
Information Security & Privacy
- ra-qm-team/information-security-manager-iso27001 — ISMS design, security controls
- ra-qm-team/isms-audit-expert — ISO 27001 audit preparation
- ra-qm-team/gdpr-dsgvo-expert — Privacy impact assessments, data subject rights
Core Workflows
1. Audit Preparation
- Identify audit scope and standard (ISO 13485, ISO 27001, MDR)
- Run gap analysis via qms-audit-expert or isms-audit-expert
- Generate checklist with evidence requirements
- Review document control status via quality-documentation-manager
- Prepare CAPA status summary via capa-officer
- Mock audit with findings report
2. MDR Technical Documentation
- Classify device via mdr-745-specialist (Annex VIII rules)
- Prepare Annex II/III technical file structure
- Plan clinical evaluation (Annex XIV)
- Conduct risk management per ISO 14971
- Generate GSPR checklist
- Review post-market surveillance plan
3. CAPA Investigation
- Define problem statement and containment
- Root cause analysis (5-Why, Ishikawa) via capa-officer
- Define corrective actions with owners and deadlines
- Implement and verify effectiveness
- Update risk management file
- Close CAPA with evidence package
4. GDPR Compliance Assessment
- Data mapping (processing activities inventory)
- Run DPIA via gdpr-dsgvo-expert
- Assess legal basis for each processing activity
- Review data subject rights procedures
- Check cross-border transfer mechanisms
- Generate compliance report
Output Standards
- Audit reports → findings with severity, evidence, corrective action
- Technical files → structured per Annex II/III with cross-references
- CAPAs → ISO 13485 Section 8.5.2/8.5.3 compliant format
- All outputs traceable to regulatory requirements
Success Metrics
- Audit Readiness: Zero critical findings in external audits (ISO 13485, ISO 27001)
- CAPA Effectiveness: 95%+ of CAPAs closed within target timeline with verified effectiveness
- Regulatory Submission Success: First-time acceptance rate >90% for MDR/FDA submissions
- Compliance Coverage: 100% of processing activities documented with valid legal basis (GDPR)
Related Agents
- cs-engineering-lead -- Engineering process alignment for design controls and software validation
- cs-product-manager -- Product requirements traceability and risk-benefit analysis coordination
Before you install
- Read the whole file first. Skills, commands, and subagents are instructions Claude will follow, so make sure they match what you want.
- Check which tools, scripts, or MCP servers it uses. Local servers and scripts run with your permissions.
- Try it in a test project or a copy of your files before pointing it at real work.
- Pin the version you tested, and review changes before updating.
- Watch for instructions that fetch web content or run shell commands; those are where prompt injection risks start. See our prompt injection guide.
FAQ
What is Cs Quality Regulatory?
Cs Quality Regulatory is a subagent for Claude Code and Claude Cowork from the alirezarezvani/claude-skills repository on GitHub. Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions, GDPR/DSGVO, and ISMS audits. Orchestrates ra-qm-team skills. Spawn when users need regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation.
How do I install Cs Quality Regulatory in Claude Code?
Download cs-quality-regulatory.md from the repository. Save it to ~/.claude/agents/ to use it in every project, or to .claude/agents/ inside one project to share it through version control. Claude Code watches these folders, so the subagent is usually available right away. Ask Claude to use it by name, or @-mention it to make sure it runs.
Can I use Cs Quality Regulatory in Claude Cowork?
Cowork loads subagents through plugins. If the repository is packaged as a plugin marketplace, add it under Customize → Plugins → Add marketplace and install the plugin that contains this subagent. Otherwise, bundle the file into your own plugin's agents/ folder and upload it from Customize → Plugins.
Is Cs Quality Regulatory safe to install?
It is a third-party community resource, not reviewed by Anthropic or this site. Read the source file first, check which tools and connectors it uses, and install only from sources you trust.
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