ra-qm-skills

Compare original and translation side by side

🇺🇸

Original

English

🇨🇳

Chinese

12 production-ready compliance skills for HealthTech and MedTech organizations.

面向医疗科技（HealthTech/MedTech）机构的12项可投入生产的合规技能。

/read ra-qm-team/regulatory-affairs-head/SKILL.md

/read ra-qm-team/regulatory-affairs-head/SKILL.md

bash

npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team

bash

npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team

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

技能	文件夹	核心方向
法规事务主管	`regulatory-affairs-head/`	FDA/MDR策略、申报
质量经理（QMR）	`quality-manager-qmr/`	质量管理体系治理、管理评审
质量经理（ISO 13485）	`quality-manager-qms-iso13485/`	质量管理体系落地、文档控制
风险管理专员	`risk-management-specialist/`	ISO 14971、FMEA、风险文件管理
CAPA专员	`capa-officer/`	根本原因分析、纠正措施
质量文档经理	`quality-documentation-manager/`	文档控制、21 CFR Part 11合规
QMS审核专家	`qms-audit-expert/`	ISO 13485内部审核
ISMS审核专家	`isms-audit-expert/`	ISO 27001安全审核
信息安全经理（ISO 27001）	`information-security-manager-iso27001/`	信息安全管理体系落地
MDR 745专员	`mdr-745-specialist/`	欧盟MDR分类、CE认证
FDA顾问	`fda-consultant-specialist/`	510(k)、PMA、QSR合规
GDPR/DSGVO专家	`gdpr-dsgvo-expert/`	隐私合规、DPIA

17 scripts, all stdlib-only:

bash

python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help

17个脚本，全部基于标准库实现：

bash

python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help