[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M71HPB8JSXCJQAG9SX8NDFW2":3,"skill-same:01M71HPB8JSXCJQAG9SX8NDFW2":82},{"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":23,"publishedAt":44,"linkOnly":45,"markdownContent":46,"markdownBody":47,"frontMatter":48,"refName":60,"commitSha":61,"skillDirectory":62,"forksCount":14,"repositoryHtmlUrl":63,"repositoryHomepageUrl":6,"ownerHtmlUrl":64,"ownerBlogUrl":65,"ownerDescription":66,"updatedAt":67,"install":68,"resources":81},"01M71HPB8JSXCJQAG9SX8NDFW2","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).","agency-black\u002FSkills","agency-black","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F234862658?v=4","01M6HWVFPNGNR5N2CX9ECSAD57","agencia.black","01M719WF77BF3HN0N9FK1APEFY",0,"MIT","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fskills\u002Fra-qm-skills\u002FSKILL.md",[18],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000030","开发工程师","PROFESSION","适用职业",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"ra qm skills","qm","regulatory","quality","cursor","control","cli","codex","gdpr","codex-cli","code","document","iso 14971","only","python","iso","for","gemini","risk","ISO 13485","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: 2.9.0\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","# 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",{"name":5,"tags":49,"agents":55,"author":58,"license":15,"version":59,"description":7},[26,50,51,52,53,54,32],"quality-management","iso-13485","mdr","fda","iso-27001",[56,33,57],"claude-code","openclaw","Alireza Rezvani","2.9.0","main","681496e0662f4c45c4758fae9d4510ae87311bf2","ra-qm-team\u002Fskills\u002Fra-qm-skills","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills","https:\u002F\u002Fgithub.com\u002Fagency-black","http:\u002F\u002Fwww.dogma.black","Las grandes ideas merecen una ejecución impecable. Construimos plataformas web, aplicaciones y ecosistemas digitales completos. Esta Trinidad es nuestro dogma.","2026-05-29 16:13:55",{"source":8,"skillName":5,"commands":69,"prompt":79,"zipAvailable":80},[70,73,76],{"tool":71,"command":72},"npx","npx skills add agency-black\u002FSkills --skill ra-qm-skills",{"tool":74,"command":75},"bunx","bunx skills add agency-black\u002FSkills --skill ra-qm-skills",{"tool":77,"command":78},"pnpm","pnpm dlx skills add agency-black\u002FSkills --skill ra-qm-skills","安装技能，技能地址：https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fskills\u002Fra-qm-skills\u002FSKILL.md",true,[],[83,108,136,166,191,216],{"skillNo":84,"name":85,"nameZh":6,"description":86,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":87,"categories":88,"keywords":89,"publishedAt":44},"01M71JZVZ0TVW7Z5DQBRWSBG8A","zarr-python","Chunked N-D arrays for cloud storage (Zarr-Python 3). Compressed arrays, parallel I\u002FO, S3\u002FGCS via fsspec, NumPy\u002FDask\u002FXarray compatible, for large-scale scientific computing pipelines.","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fzarr-python\u002FSKILL.md",[],[90,38,91,92,93,94,95,96,97,98,99,100,101,40,102,103,104,105,106,107],"zarr python","zarr","arrays","Cloud Storage","remote","workflows","scientific","read","write","edit","parallel","dask","s3fs","use","numpy","s3","scientific computing","scale",{"skillNo":109,"name":110,"nameZh":6,"description":111,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":112,"sourceHtmlUrl":113,"categories":114,"keywords":120,"publishedAt":44},"01M71JYXC5VAEJT8KXN5GRK32S","xvary-stock-research","Thesis-driven equity analysis from public SEC EDGAR and market data; \u002Fanalyze, \u002Fscore, \u002Fcompare workflows with bundled Python tools (Claude Code, Cursor, Codex).","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fxvary-stock-research\u002FLICENSE","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fxvary-stock-research\u002FSKILL.md",[115],{"categoryNo":116,"categoryName":117,"taxonomyType":118,"taxonomyTypeDesc":119},"01JBSEEDCAT000000000000021","资料检索与研究","SCENARIO","使用场景",[121,122,123,124,125,126,127,38,128,95,129,34,130,131,132,133,134,31,28,135],"xvary","stock","research","xvary stock research","sec edgar","community","equity","thesis","analysis","Market","compare","market data","analyze","with","2026",{"skillNo":137,"name":138,"nameZh":6,"description":139,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":140,"licenseFileUrl":141,"sourceHtmlUrl":142,"categories":143,"keywords":150,"publishedAt":44},"01M71JVSDPDQ5040YBN6J1ASKY","webapp-testing","Toolkit for interacting with and testing local web applications using Playwright. Supports verifying frontend functionality, debugging UI behavior, capturing browser screenshots, and viewing browser logs.","Apache-2.0","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fwebapp-testing\u002FLICENSE.txt","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fwebapp-testing\u002FSKILL.md",[144,147],{"categoryNo":145,"categoryName":146,"taxonomyType":118,"taxonomyTypeDesc":119},"01JBSEEDCAT000000000000008","测试与质量",{"categoryNo":148,"categoryName":149,"taxonomyType":118,"taxonomyTypeDesc":119},"01JBSEEDCAT000000000000009","前端开发",[151,152,153,40,154,155,156,157,158,159,160,134,161,162,163,164,165],"webapp","testing","webapp testing","applications","local","frontend","debugging","toolkit","logs","browser","playwright","web","behavior","ui","screenshots",{"skillNo":167,"name":168,"nameZh":6,"description":169,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":140,"licenseFileUrl":170,"sourceHtmlUrl":171,"categories":172,"keywords":174,"publishedAt":44},"01M71JV64CW7R6FYYK9JWWGW0X","web-artifacts-builder","Suite of tools for creating elaborate, multi-component claude.ai HTML artifacts using modern frontend web technologies (React, Tailwind CSS, shadcn\u002Fui). Use for complex artifacts requiring state management, routing, or shadcn\u002Fui components - not for simple single-file HTML\u002FJSX artifacts.","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fweb-artifacts-builder\u002FLICENSE.txt","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fweb-artifacts-builder\u002FSKILL.md",[173],{"categoryNo":148,"categoryName":149,"taxonomyType":118,"taxonomyTypeDesc":119},[175,176,177,162,178,179,180,40,181,182,156,183,103,184,185,186,187,188,189,190],"builder","artifacts builder","artifacts","web artifacts builder","single-file","css","Tailwind","ui components","single","file","components","react","multi","state","routing","state management",{"skillNo":192,"name":193,"nameZh":6,"description":194,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":195,"categories":196,"keywords":198,"publishedAt":44},"01M71JS4X2FRY41DE84DEP06MN","vercel-react-view-transitions","Guide for implementing smooth, native-feeling animations using React's View Transition API (`\u003CViewTransition>` component, `addTransitionType`, and CSS view transition pseudo-elements). 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\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fvercel-react-view-transitions\u002FSKILL.md",[197],{"categoryNo":148,"categoryName":149,"taxonomyType":118,"taxonomyTypeDesc":119},[186,199,200,201,202,203,204,205,206,180,207,208,209,210,211,185,212,213,214,215],"vercel react view transitions","view","react view transitions","vercel","transitions","shared","back","Animation","types","states","element","implementing","when","api","route","create","libraries",{"skillNo":217,"name":218,"nameZh":6,"description":219,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":220,"categories":221,"keywords":223,"publishedAt":44},"01M71JS1WZ1J4F9YVC2203JBJW","vercel-react-native-skills","React Native and Expo best practices for building performant mobile apps. Use when building React Native components, optimizing list performance, implementing animations, or working with native modules. Triggers on tasks involving React Native, Expo, mobile performance, or native platform APIs.","https:\u002F\u002Fgithub.com\u002Fagency-black\u002FSkills\u002Fblob\u002Fmain\u002Fvercel-react-native-skills\u002FSKILL.md",[222],{"categoryNo":148,"categoryName":149,"taxonomyType":118,"taxonomyTypeDesc":119},[202,224,186,225,226,227,228,229,230,40,231,210,232,103,233,234,211,235,236,185],"vercel react native skills","react native","native","react native skills","modules","platform","animations","performance","triggers","react native components","apps","best practices","tasks"]