[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6F2SFBEC8ZS6V97TA45577E":3,"skill-same:01M6F2SFBEC8ZS6V97TA45577E":89},{"skillNo":4,"name":5,"nameZh":6,"description":7,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":16,"categories":17,"keywords":28,"publishedAt":49,"linkOnly":50,"markdownContent":51,"markdownBody":52,"frontMatter":53,"refName":66,"commitSha":67,"skillDirectory":68,"forksCount":69,"repositoryHtmlUrl":70,"repositoryHomepageUrl":71,"ownerHtmlUrl":72,"ownerBlogUrl":6,"ownerDescription":73,"updatedAt":74,"install":75,"resources":88},"01M6F2SFBEC8ZS6V97TA45577E","ra-qm-skills",null,"12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017\u002F745, FDA 510(k)\u002FPMA, ISO 27001 ISMS, GDPR\u002FDSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).","ComeOnOliver\u002Fskillshub","ComeOnOliver","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F43215937?v=4","01M6E5JNFECJAAVFE0W7SMWWD2","Haoran Shu","01M6E5JNNDQS7AJZDYFQ8TPZCK",67,"MIT","https:\u002F\u002Fgithub.com\u002FComeOnOliver\u002Fskillshub\u002Fblob\u002Fmain\u002Fskills\u002Falirezarezvani\u002Fclaude-skills\u002Fra-qm-team\u002FSKILL.md",[18,23],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000023","Skill与智能体开发","SCENARIO","使用场景",{"categoryNo":24,"categoryName":25,"taxonomyType":26,"taxonomyTypeDesc":27},"01JBSEEDCAT000000000000030","开发工程师","PROFESSION","适用职业",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"qm","ra qm skills","quality","ISO 13485","iso 14971","iso","control","document","only","cursor","openclaw","risk","Tools","gdpr","code","gemini cli","codex","python","gemini","cli","2026-11-10 10:12:30",false,"---\nname: \"ra-qm-skills\"\ndescription: \"12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017\u002F745, FDA 510(k)\u002FPMA, ISO 27001 ISMS, GDPR\u002FDSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).\"\nversion: 1.0.0\nauthor: Alireza Rezvani\nlicense: MIT\ntags:\n  - regulatory\n  - quality-management\n  - iso-13485\n  - mdr\n  - fda\n  - iso-27001\n  - gdpr\nagents:\n  - claude-code\n  - codex-cli\n  - openclaw\n---\n\n# Regulatory Affairs & Quality Management Skills\n\n12 production-ready compliance skills for HealthTech and MedTech organizations.\n\n## Quick Start\n\n### Claude Code\n```\n\u002Fread ra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md\n```\n\n### Codex CLI\n```bash\nnpx agent-skills-cli add alirezarezvani\u002Fclaude-skills\u002Fra-qm-team\n```\n\n## Skills Overview\n\n| Skill | Folder | Focus |\n|-------|--------|-------|\n| Regulatory Affairs Head | `regulatory-affairs-head\u002F` | FDA\u002FMDR strategy, submissions |\n| Quality Manager (QMR) | `quality-manager-qmr\u002F` | QMS governance, management review |\n| Quality Manager (ISO 13485) | `quality-manager-qms-iso13485\u002F` | QMS implementation, doc control |\n| Risk Management Specialist | `risk-management-specialist\u002F` | ISO 14971, FMEA, risk files |\n| CAPA Officer | `capa-officer\u002F` | Root cause analysis, corrective actions |\n| Quality Documentation Manager | `quality-documentation-manager\u002F` | Document control, 21 CFR Part 11 |\n| QMS Audit Expert | `qms-audit-expert\u002F` | ISO 13485 internal audits |\n| ISMS Audit Expert | `isms-audit-expert\u002F` | ISO 27001 security audits |\n| Information Security Manager | `information-security-manager-iso27001\u002F` | ISMS implementation |\n| MDR 745 Specialist | `mdr-745-specialist\u002F` | EU MDR classification, CE marking |\n| FDA Consultant | `fda-consultant-specialist\u002F` | 510(k), PMA, QSR compliance |\n| GDPR\u002FDSGVO Expert | `gdpr-dsgvo-expert\u002F` | Privacy compliance, DPIA |\n\n## Python Tools\n\n17 scripts, all stdlib-only:\n\n```bash\npython3 risk-management-specialist\u002Fscripts\u002Frisk_matrix_calculator.py --help\npython3 gdpr-dsgvo-expert\u002Fscripts\u002Fgdpr_compliance_checker.py --help\n```\n\n## Rules\n\n- Load only the specific skill SKILL.md you need\n- Always verify compliance outputs against current regulations\n\n","# Regulatory Affairs & Quality Management Skills\n\n12 production-ready compliance skills for HealthTech and MedTech organizations.\n\n## Quick Start\n\n### Claude Code\n```\n\u002Fread ra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md\n```\n\n### Codex CLI\n```bash\nnpx agent-skills-cli add alirezarezvani\u002Fclaude-skills\u002Fra-qm-team\n```\n\n## Skills Overview\n\n| Skill | Folder | Focus |\n|-------|--------|-------|\n| Regulatory Affairs Head | `regulatory-affairs-head\u002F` | FDA\u002FMDR strategy, submissions |\n| Quality Manager (QMR) | `quality-manager-qmr\u002F` | QMS governance, management review |\n| Quality Manager (ISO 13485) | `quality-manager-qms-iso13485\u002F` | QMS implementation, doc control |\n| Risk Management Specialist | `risk-management-specialist\u002F` | ISO 14971, FMEA, risk files |\n| CAPA Officer | `capa-officer\u002F` | Root cause analysis, corrective actions |\n| Quality Documentation Manager | `quality-documentation-manager\u002F` | Document control, 21 CFR Part 11 |\n| QMS Audit Expert | `qms-audit-expert\u002F` | ISO 13485 internal audits |\n| ISMS Audit Expert | `isms-audit-expert\u002F` | ISO 27001 security audits |\n| Information Security Manager | `information-security-manager-iso27001\u002F` | ISMS implementation |\n| MDR 745 Specialist | `mdr-745-specialist\u002F` | EU MDR classification, CE marking |\n| FDA Consultant | `fda-consultant-specialist\u002F` | 510(k), PMA, QSR compliance |\n| GDPR\u002FDSGVO Expert | `gdpr-dsgvo-expert\u002F` | Privacy compliance, DPIA |\n\n## Python Tools\n\n17 scripts, all stdlib-only:\n\n```bash\npython3 risk-management-specialist\u002Fscripts\u002Frisk_matrix_calculator.py --help\npython3 gdpr-dsgvo-expert\u002Fscripts\u002Fgdpr_compliance_checker.py --help\n```\n\n## Rules\n\n- Load only the specific skill SKILL.md you need\n- Always verify compliance outputs against current regulations\n\n",{"name":5,"tags":54,"agents":61,"author":64,"license":15,"version":65,"description":7},[55,56,57,58,59,60,42],"regulatory","quality-management","iso-13485","mdr","fda","iso-27001",[62,63,39],"claude-code","codex-cli","Alireza Rezvani","1.0.0","main","def8531e65114c0fca8fb8551c1871ee0eed705c","skills\u002Falirezarezvani\u002Fclaude-skills\u002Fra-qm-team",24,"https:\u002F\u002Fgithub.com\u002FComeOnOliver\u002Fskillshub","https:\u002F\u002Fskillshub.wtf","https:\u002F\u002Fgithub.com\u002FComeOnOliver","AI & Blockchain Engineer\r\n","2026-06-24 22:07:19",{"source":8,"skillName":5,"commands":76,"prompt":86,"zipAvailable":87},[77,80,83],{"tool":78,"command":79},"npx","npx skills add ComeOnOliver\u002Fskillshub --skill ra-qm-skills",{"tool":81,"command":82},"bunx","bunx skills add ComeOnOliver\u002Fskillshub --skill 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