[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6Q7HKP6FC061PNFBM7H58F8":3,"skill-same:01M6Q7HKP6FC061PNFBM7H58F8":179},{"skillNo":4,"name":5,"nameZh":6,"description":7,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":15,"categories":16,"keywords":27,"publishedAt":48,"linkOnly":49,"markdownContent":50,"markdownBody":51,"frontMatter":52,"refName":87,"commitSha":88,"skillDirectory":89,"forksCount":90,"repositoryHtmlUrl":91,"repositoryHomepageUrl":6,"ownerHtmlUrl":92,"ownerBlogUrl":6,"ownerDescription":6,"updatedAt":93,"install":94,"resources":106},"01M6Q7HKP6FC061PNFBM7H58F8","ra-qm-skills",null,"Manage — 12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. 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ISO 13485 QMS, MDR 2017\u002F745, FDA 510(k)\u002FPMA, ISO 27001 ISMS, GDPR\u002FDSGVO, risk mana\"\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\nexecutor: LLM_BEHAVIOR\nskill_id: business.ra-qm-team\nstatus: ADOPTED\nsecurity: {level: high, pii: false, approval_required: true}\nanchors:\n  - business\n  - llm\n  - agent\n  - compliance\ntier: 2\ninput_schema:\n  - name: code_or_task\n    type: string\n    description: \"Code snippet, script, or task description to process\"\n    required: true\noutput_schema:\n  - name: result\n    type: string\n    description: \"Generated or refactored code output\"\n  - name: explanation\n    type: string\n    description: \"Explanation of changes or implementation decisions\"\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---\n\n## Why This Skill Exists\n\nManage — 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 mana\n\n\u003C!-- SR_40: auto-generated from frontmatter `purpose`\u002F`description` (OPP-Phase3). Expand with domain-specific rationale. -->\n\n## When to Use\n\nUse this skill when the task requires ra qm skills capabilities.\n\n\u003C!-- SR_40: auto-generated from frontmatter `when`\u002F`description` (OPP-Phase3). -->\n\n## What If Fails\n\nIf this skill fails to produce the expected output: (1) verify input completeness, (2) retry with more specific context, (3) fall back to the parent workflow without this skill.\n\n\u003C!-- SR_40: auto-generated from frontmatter `what_if_fails` (OPP-Phase3). -->\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---\n\n## Why This Skill Exists\n\nManage — 12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. 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Expand with domain-specific rationale. -->\n\n## When to Use\n\nUse this skill when the task requires ra qm skills capabilities.\n\n\u003C!-- SR_40: auto-generated from frontmatter `when`\u002F`description` (OPP-Phase3). -->\n\n## What If Fails\n\nIf this skill fails to produce the expected output: (1) verify input completeness, (2) retry with more specific context, (3) fall back to the parent workflow without this skill.\n\n\u003C!-- SR_40: auto-generated from frontmatter `what_if_fails` (OPP-Phase3). -->\n",{"name":5,"tags":53,"tier":13,"agents":61,"author":64,"status":65,"anchors":66,"license":14,"version":70,"executor":71,"security":72,"skill_id":75,"description":7,"input_schema":76,"output_schema":81},[54,55,56,57,58,59,60],"regulatory","quality-management","iso-13485","mdr","fda","iso-27001","gdpr",[62,63,39],"claude-code","codex-cli","Alireza 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Use this skill whenever the user wants to add page transitions, animate route changes, create shared element animations, animate enter\u002Fexit of components, animate list reorder, implement directional (forward\u002Fback) navigation animations, or integrate view transitions in Next.js. Also use when the user mentions view transitions, `startViewTransition`, `ViewTransition`, transition types, or asks about animating between UI states in React without third-party animation libraries.","https:\u002F\u002Fgithub.com\u002Fthiagofernandes1987-create\u002FAPEX\u002Fblob\u002Fmain\u002Fskills\u002Fengineering_agentops\u002Freact-view-transitions\u002FSKILL.md",[186,189],{"categoryNo":187,"categoryName":188,"taxonomyType":20,"taxonomyTypeDesc":21},"01JBSEEDCAT000000000000009","前端开发",{"categoryNo":18,"categoryName":19,"taxonomyType":20,"taxonomyTypeDesc":21},[191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210],"react","view","vercel","vercel react view transitions","react view transitions","transitions","css","components","component","create","ui","Animation","list","guide","integrate","fallback","shared","element","implementing","capability",{"skillNo":212,"name":213,"nameZh":6,"description":214,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":215,"categories":216,"keywords":219,"publishedAt":48},"01M6QGXZ0BNVMKNZNQVZ3VKDRS","vercel-react-best-practices","React and Next.js performance optimization guidelines from Vercel Engineering. 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Triggers on tasks involving React components, Next.js pages, data fetching, bundle optimization, or performance improvements.","https:\u002F\u002Fgithub.com\u002Fthiagofernandes1987-create\u002FAPEX\u002Fblob\u002Fmain\u002Fskills\u002Fengineering_agentops\u002Freact-best-practices\u002FSKILL.md",[217,218],{"categoryNo":187,"categoryName":188,"taxonomyType":20,"taxonomyTypeDesc":21},{"categoryNo":18,"categoryName":19,"taxonomyType":20,"taxonomyTypeDesc":21},[191,220,221,222,193,223,224,225,226,198,227,228,44,229,230,231,232,233,36,234],"vercel react best practices","best practices","react best practices","writing","performance","orchestration","workflow","react components","tasks","data","analysis","refactoring","never","next","data fetching",{"skillNo":236,"name":237,"nameZh":6,"description":238,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":239,"categories":240,"keywords":252,"publishedAt":48},"01M6QE9XVT956E57Y5FK89AWCK","terraform-patterns","Implement — Terraform infrastructure-as-code agent skill and plugin for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. 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