[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6CT36P1YBDDP079ZSWDZAZ7":3,"skill-same:01M6CT36P1YBDDP079ZSWDZAZ7":61},{"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":33,"linkOnly":34,"markdownContent":35,"markdownBody":36,"frontMatter":37,"refName":39,"commitSha":40,"skillDirectory":41,"forksCount":42,"repositoryHtmlUrl":43,"repositoryHomepageUrl":43,"ownerHtmlUrl":44,"ownerBlogUrl":6,"ownerDescription":45,"updatedAt":46,"install":47,"resources":60},"01M6CT36P1YBDDP079ZSWDZAZ7","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.","Sam-06060\u002Fjarvis-assistant","Sam-06060","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F208600848?v=4","01M6CRKT7C7FXD21V6HXF293S0","Samson Frank Ganta","01M6CRKTBEKYFD8YX5Z1GT99EE",6,"Apache-2.0","https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant\u002Fblob\u002Fmain\u002Fmodules\u002Fagent_skills\u002Fawesome-skills\u002Fplaybooks\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],"compliance","fda","fda medtech compliance auditor","validation","technical","files","expert","community","device","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":38,"source":31,"description":7},"unknown","main","a50a3aa6b39fb0e1b7db88bef1bfc9c93606e126","modules\u002Fagent_skills\u002Fawesome-skills\u002Fplaybooks\u002Ffda-medtech-compliance-auditor",0,"https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant","https:\u002F\u002Fgithub.com\u002FSam-06060","Mobile Application Developer | Kotlin | Flutter, KMP, Swfit, Android,Swift UI | Building at Saar It Resources | Creator of Jarvis (AI Assistant)","2026-06-23 05:13:38",{"source":8,"skillName":5,"commands":48,"prompt":58,"zipAvailable":59},[49,52,55],{"tool":50,"command":51},"npx","npx skills add Sam-06060\u002Fjarvis-assistant --skill fda-medtech-compliance-auditor",{"tool":53,"command":54},"bunx","bunx skills add Sam-06060\u002Fjarvis-assistant --skill fda-medtech-compliance-auditor",{"tool":56,"command":57},"pnpm","pnpm dlx skills add Sam-06060\u002Fjarvis-assistant --skill fda-medtech-compliance-auditor","安装技能，技能地址：https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant\u002Fblob\u002Fmain\u002Fmodules\u002Fagent_skills\u002Fawesome-skills\u002Fplaybooks\u002Ffda-medtech-compliance-auditor\u002FSKILL.md",true,[],[62,75,91,118,137,162],{"skillNo":63,"name":64,"nameZh":6,"description":6,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":65,"categories":66,"keywords":72,"publishedAt":33},"01M6GDRVS6FXX3ESH0C9DW01C0","test_skill","https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant\u002Fblob\u002Fmain\u002Fscratch\u002Ftest_skill\u002FSKILL.md",[67],{"categoryNo":68,"categoryName":69,"taxonomyType":70,"taxonomyTypeDesc":71},"01JBSEEDCAT000000000000008","测试与质量","SCENARIO","使用场景",[73,74],"Test Skill","test",{"skillNo":76,"name":77,"nameZh":6,"description":78,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":79,"categories":80,"keywords":81,"publishedAt":33},"01M6GDRQ40HX22MA6XWC31RHHK","zustand-store-ts","Create Zustand stores following established patterns with proper TypeScript types and middleware.","https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant\u002Fblob\u002Fmain\u002Fmodules\u002Fagent_skills\u002Fawesome-skills\u002Fplaybooks\u002Fzustand-store-ts\u002FSKILL.md",[],[82,83,84,85,86,87,88,31,89,90],"zustand store ts","zustand","store","with","types","middleware","patterns","create","typescript",{"skillNo":92,"name":93,"nameZh":6,"description":94,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":95,"categories":96,"keywords":100,"publishedAt":33},"01M6GDRKEA0WE670SPFWX5GKCN","zoom-automation","Automate Zoom meeting creation, management, recordings, webinars, and participant tracking via Rube MCP (Composio). Always search tools first for current schemas.","https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant\u002Fblob\u002Fmain\u002Fmodules\u002Fagent_skills\u002Fawesome-skills\u002Fplaybooks\u002Fzoom-automation\u002FSKILL.md",[97],{"categoryNo":98,"categoryName":99,"taxonomyType":70,"taxonomyTypeDesc":71},"01JBSEEDCAT000000000000023","Skill与智能体开发",[101,102,103,104,105,106,107,108,109,110,111,112,113,114,31,115,116,117],"automation","zoom automation","zoom","first","Tools","search","MCP","via","meeting","automate","critical","creation","webinars","composio","recordings","management","tracking",{"skillNo":119,"name":120,"nameZh":6,"description":121,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":122,"categories":123,"keywords":125,"publishedAt":33},"01M6GDRFS1452PC71JQ38S24HR","zoho-crm-automation","Automate Zoho CRM tasks via Rube MCP (Composio): create\u002Fupdate records, search contacts, manage leads, and convert leads. Always search tools first for current schemas.","https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant\u002Fblob\u002Fmain\u002Fmodules\u002Fagent_skills\u002Fawesome-skills\u002Fplaybooks\u002Fzoho-crm-automation\u002FSKILL.md",[124],{"categoryNo":98,"categoryName":99,"taxonomyType":70,"taxonomyTypeDesc":71},[126,101,127,128,129,130,131,31,106,132,114,133,111,110,105,134,89,135,107,136],"crm automation","zoho crm","crm","zoho crm automation","zoho","leads","contacts","records","update","tasks","manage",{"skillNo":138,"name":139,"nameZh":6,"description":140,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":141,"categories":142,"keywords":146,"publishedAt":33},"01M6GDRCKQBAVTGHX5XBH26KPZ","zod-validation-expert","Expert in Zod — TypeScript-first schema validation. Covers parsing, custom errors, refinements, type inference, and integration with React Hook Form, Next.js, and tRPC.","https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant\u002Fblob\u002Fmain\u002Fmodules\u002Fagent_skills\u002Fawesome-skills\u002Fplaybooks\u002Fzod-validation-expert\u002FSKILL.md",[143],{"categoryNo":144,"categoryName":145,"taxonomyType":70,"taxonomyTypeDesc":71},"01JBSEEDCAT000000000000009","前端开发",[30,147,148,27,149,90,150,151,152,153,154,155,85,156,157,158,159,31,160,161],"zod","zod validation expert","react","safe","parsing","errors","schema validation","react hook form","hook","trpc","form","type","next","schema","Next.js",{"skillNo":163,"name":164,"nameZh":6,"description":165,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":166,"categories":167,"keywords":169,"publishedAt":33},"01M6GDR658B08K4MY0RWD4A6EH","zeroize-audit","Detects missing zeroization of sensitive data in source code and identifies zeroization removed by compiler optimizations, with assembly-level analysis, and control-flow verification. Use for auditing C\u002FC++\u002FRust code handling secrets, keys, passwords, or other sensitive data.","https:\u002F\u002Fgithub.com\u002FSam-06060\u002Fjarvis-assistant\u002Fblob\u002Fmain\u002Fmodules\u002Fagent_skills\u002Fawesome-skills\u002Fplaybooks\u002Fzeroize-audit\u002FSKILL.md",[168],{"categoryNo":98,"categoryName":99,"taxonomyType":70,"taxonomyTypeDesc":71},[170,171,172,173,174,175,176,177,31,178,179,180,181,182,183,184,185,186,187,107],"zeroize audit","audit","write","passwords","get","project","c++","activate","assembly","read","Bash","secrets","analysis","data","flow","verification","code","rust"]