Individual skill
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.
.gemini/skills/cs-quality-regulatory/SKILL.md
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- Last checked
- Nov 10, 2026
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- Repository last updated
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- License
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Observed agent integration: gemini-cli
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SKILL.mdcore · 3,887 bytes
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# cs-quality-regulatory
## 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