[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6XGHQJXQVRPNAGAW8SW80J4":3,"skill-same:01M6XGHQJXQVRPNAGAW8SW80J4":67},{"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":42,"linkOnly":43,"markdownContent":44,"markdownBody":45,"frontMatter":46,"refName":47,"commitSha":48,"skillDirectory":49,"forksCount":14,"repositoryHtmlUrl":50,"repositoryHomepageUrl":6,"ownerHtmlUrl":51,"ownerBlogUrl":6,"ownerDescription":6,"updatedAt":52,"install":53,"resources":66},"01M6XGHQJXQVRPNAGAW8SW80J4","fda-medtech-compliance-auditor",null,"Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.","sapsapshen\u002Fai-memory-router","sapsapshen","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F20347959?v=4","01M6XDQEF1DP50DKF37H81J3J5","shenmian","01M6XDQEJPE41Y3DT2763X8ZJN",0,"MIT","https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router\u002Fblob\u002Fmain\u002Fskills-store\u002Fcopilot\u002Ffda-medtech-compliance-auditor\u002FSKILL.md",[18],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000037","律师与法务","PROFESSION","适用职业",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"compliance","fda","auditor","compliance auditor","fda medtech compliance auditor","unknown","validation","for","reviews","iec 62304","software","cfr","medical","device","community","expert","files","technical","2026-11-10 10:12:30",false,"---\nname: fda-medtech-compliance-auditor\ndescription: \"Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.\"\nrisk: unknown\nsource: community\n---\n\n# FDA MedTech Compliance Auditor\n\n## Overview\n\nThis skill transforms your AI assistant into a specialized MedTech Compliance Auditor. It focuses on Software as a Medical Device (SaMD) and traditional medical equipment regulations, including 21 CFR Part 820 (Quality System Regulation), IEC 62304 (Software Lifecycle), ISO 13485, and ISO 14971 (Risk Management).\n\n## When to Use This Skill\n\n- Use when reviewing Software Validation Protocols for Medical Devices.\n- Use when auditing a Design History File (DHF) for a software-based diagnostic tool.\n- Use when ensuring IT infrastructure meets 21 CFR Part 11 requirements for electronic records.\n- Use when preparing a CAPA (Corrective and Preventive Action) for a software defect.\n\n## How It Works\n\n1. **Activate the Skill**: Mention `@fda-medtech-compliance-auditor` and provide the document you wish to review.\n2. **Specify the Standard**: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304.\n3. **Receive Findings**: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with regulatory citations.\n4. **Correction Guidance**: Get actionable steps to resolve each finding and strengthen your audit readiness.\n\n## Examples\n\n### Example 1: CAPA Root Cause Review\n\n**Scenario:** A CAPA was opened for a software defect in a Class II device. The documented root cause is “developer error — unclear requirements.” The corrective action is developer retraining.\n\n**Finding:**\n\n```text\nFDA AUDIT FINDING\nSeverity: Major\nCitation: 21 CFR 820.100(a)(2) \u002F IEC 62304 Section 5.1\n\nAnalysis:\n\"Developer error\" is a symptom, not a root cause. Retraining alone is\na known red flag for FDA inspectors and will not withstand scrutiny.\nThe true root cause lies in the software requirements engineering\nprocess itself — not an individual.\n\nRequired Actions:\n1. Perform a 5-Whys or Fishbone analysis targeting the requirements\n   gathering and review process.\n2. Update the SRS (Software Requirements Specification) and the\n   corresponding process SOP.\n3. Document an effectiveness check with a measurable criterion\n   (e.g., zero requirements-related defects in next 3 releases).\n4. Do not close the CAPA on retraining alone.\n```\n\n## Best Practices\n\n- ✅ **Do:** Provide exact wording from SOPs, risk tables, or validation plans for the most accurate review.\n- ✅ **Do:** Expect strict interpretations — the goal is to find weaknesses before a real inspector does.\n- ❌ **Don't:** Forget to link every software defect to a clinical risk item in your ISO 14971 risk file.\n- ❌ **Don't:** Assume \"we tested it and it works\" satisfies IEC 62304 software verification requirements.\n","# FDA MedTech Compliance Auditor\n\n## Overview\n\nThis skill transforms your AI assistant into a specialized MedTech Compliance Auditor. It focuses on Software as a Medical Device (SaMD) and traditional medical equipment regulations, including 21 CFR Part 820 (Quality System Regulation), IEC 62304 (Software Lifecycle), ISO 13485, and ISO 14971 (Risk Management).\n\n## When to Use This Skill\n\n- Use when reviewing Software Validation Protocols for Medical Devices.\n- Use when auditing a Design History File (DHF) for a software-based diagnostic tool.\n- Use when ensuring IT infrastructure meets 21 CFR Part 11 requirements for electronic records.\n- Use when preparing a CAPA (Corrective and Preventive Action) for a software defect.\n\n## How It Works\n\n1. **Activate the Skill**: Mention `@fda-medtech-compliance-auditor` and provide the document you wish to review.\n2. **Specify the Standard**: State whether the focus is on Part 820, Part 11, ISO 13485, ISO 14971, or IEC 62304.\n3. **Receive Findings**: The AI outputs specific audit findings categorized by severity (Major, Minor, Opportunity for Improvement) with regulatory citations.\n4. **Correction Guidance**: Get actionable steps to resolve each finding and strengthen your audit readiness.\n\n## Examples\n\n### Example 1: CAPA Root Cause Review\n\n**Scenario:** A CAPA was opened for a software defect in a Class II device. The documented root cause is “developer error — unclear requirements.” The corrective action is developer retraining.\n\n**Finding:**\n\n```text\nFDA AUDIT FINDING\nSeverity: Major\nCitation: 21 CFR 820.100(a)(2) \u002F IEC 62304 Section 5.1\n\nAnalysis:\n\"Developer error\" is a symptom, not a root cause. Retraining alone is\na known red flag for FDA inspectors and will not withstand scrutiny.\nThe true root cause lies in the software requirements engineering\nprocess itself — not an individual.\n\nRequired Actions:\n1. Perform a 5-Whys or Fishbone analysis targeting the requirements\n   gathering and review process.\n2. Update the SRS (Software Requirements Specification) and the\n   corresponding process SOP.\n3. Document an effectiveness check with a measurable criterion\n   (e.g., zero requirements-related defects in next 3 releases).\n4. Do not close the CAPA on retraining alone.\n```\n\n## Best Practices\n\n- ✅ **Do:** Provide exact wording from SOPs, risk tables, or validation plans for the most accurate review.\n- ✅ **Do:** Expect strict interpretations — the goal is to find weaknesses before a real inspector does.\n- ❌ **Don't:** Forget to link every software defect to a clinical risk item in your ISO 14971 risk file.\n- ❌ **Don't:** Assume \"we tested it and it works\" satisfies IEC 62304 software verification requirements.\n",{"name":5,"risk":29,"source":38,"description":7},"main","7a38d8e7073e61c16eda85681cb32fb68a8657a5","skills-store\u002Fcopilot\u002Ffda-medtech-compliance-auditor","https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router","https:\u002F\u002Fgithub.com\u002Fsapsapshen","2026-04-14 21:12:12",{"source":8,"skillName":5,"commands":54,"prompt":64,"zipAvailable":65},[55,58,61],{"tool":56,"command":57},"npx","npx skills add sapsapshen\u002Fai-memory-router --skill fda-medtech-compliance-auditor",{"tool":59,"command":60},"bunx","bunx skills add sapsapshen\u002Fai-memory-router --skill fda-medtech-compliance-auditor",{"tool":62,"command":63},"pnpm","pnpm dlx skills add sapsapshen\u002Fai-memory-router --skill fda-medtech-compliance-auditor","安装技能，技能地址：https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router\u002Fblob\u002Fmain\u002Fskills-store\u002Fcopilot\u002Ffda-medtech-compliance-auditor\u002FSKILL.md",true,[],[68,87,113,123,136,154],{"skillNo":69,"name":70,"nameZh":6,"description":71,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":72,"categories":73,"keywords":75,"publishedAt":42},"01M71ATQRKG48SH06FQ697T5G9","wechat-search","Search WeChat Official Account articles using OpenClaw's web search and fetch capabilities with compliance-focused design.","https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router\u002Fblob\u002Fmain\u002Fskills-store\u002Fopenclaw\u002Fwechat-search-release\u002FSKILL.md",[74],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},[76,77,78,79,80,81,82,24,83,84,85,86],"wechat search","wechat","search","capabilities","openclaw","design","web search","web","official","fetch","with",{"skillNo":88,"name":89,"nameZh":6,"description":90,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":91,"categories":92,"keywords":93,"publishedAt":42},"01M71ATNAVGZB35PFYM2GC5N00","trend-tap","Real-time trending topics aggregator across 7 platforms (X\u002FTwitter, Reddit, Google Trends, Hacker News, Zhihu, Bilibili, Weibo). Trigger: when user says 'trend', 'trends', 'trend tap', '热点', '热搜', or asks what is trending\u002Fhot. Do NOT use web_search — this skill already fetches live data from all platforms with zero API keys.","https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router\u002Fblob\u002Fmain\u002Fskills-store\u002Fopenclaw\u002Ftrend-tap\u002FSKILL.md",[],[94,95,96,97,98,99,78,100,101,102,103,104,105,106,107,108,109,110,111,112],"trend","trend tap","tap","api keys","Bash","time","trending","hacker","aggregator","do","when","brew","live","data","google","install","read","across","api",{"skillNo":114,"name":115,"nameZh":6,"description":116,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":117,"categories":118,"keywords":119,"publishedAt":42},"01M71ATJ9AM5KM15AA8PS302EB","trend-radar","Real-time trending topics aggregator across 7 platforms (X\u002FTwitter, Reddit, Google Trends, Hacker News, Zhihu, Bilibili, Weibo). Trigger: when user says 'trend', 'trends', 'trend pulse', '热点', '热搜', or asks what is trending\u002Fhot. Do NOT use web_search — this skill already fetches live data from all platforms with zero API keys.","https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router\u002Fblob\u002Fmain\u002Fskills-store\u002Fopenclaw\u002Ftrend-radar\u002FSKILL.md",[],[120,121,94,105,106,107,108,98,78,110,122,111,112,104,102,101,100,109,99,97],"trend radar","radar","pulse",{"skillNo":124,"name":125,"nameZh":6,"description":126,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":127,"categories":128,"keywords":129,"publishedAt":42},"01M71ATGF095N3EJM9G8SD0BB5","tech-news-daily","每日科技新闻汇——从全球多个 RSS 源抓取最新科技新闻，翻译（英→中）、去重、排版成每日简报。当用户询问科技新闻、科技新鲜事、每日科技、技术动态、Daily Tech News 或类似表达时触发此技能。","https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router\u002Fblob\u002Fmain\u002Fskills-store\u002Fopenclaw\u002Ftech-news-daily\u002FSKILL.md",[],[130,131,132,133,134,135],"news","tech","tech news daily","daily","rss","翻译",{"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":15,"licenseFileUrl":6,"sourceHtmlUrl":140,"categories":141,"keywords":147,"publishedAt":42},"01M71ATFAEAMQ17M70NQNY7SR8","summarize","Summarize URLs or files with the summarize CLI (web, PDFs, images, audio, YouTube).","https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router\u002Fblob\u002Fmain\u002Fskills-store\u002Fopenclaw\u002Fsummarize\u002FSKILL.md",[142],{"categoryNo":143,"categoryName":144,"taxonomyType":145,"taxonomyTypeDesc":146},"01JBSEEDCAT000000000000021","资料检索与研究","SCENARIO","使用场景",[138,83,148,149,150,86,105,151,152,40,96,153,109],"Audio","cli","youtube","images","https","pdfs",{"skillNo":155,"name":156,"nameZh":6,"description":157,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":158,"categories":159,"keywords":160,"publishedAt":42},"01M71ATDNS3R0M4H936PACQAWZ","sonoscli","Control Sonos speakers (discover\u002Fstatus\u002Fplay\u002Fvolume\u002Fgroup).","https:\u002F\u002Fgithub.com\u002Fsapsapshen\u002Fai-memory-router\u002Fblob\u002Fmain\u002Fskills-store\u002Fopenclaw\u002Fsonoscli\u002FSKILL.md",[],[156,161,162,163,109,164,152,165,166,167,168,169],"status","play","go","latest","github","discover","control","cmd","volume"]