[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6KC1PS7JKS8XK5ERT4M1VEN":3,"skill-same:01M6KC1PS7JKS8XK5ERT4M1VEN":92},{"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":18,"publishedAt":39,"linkOnly":40,"markdownContent":41,"markdownBody":42,"frontMatter":43,"refName":54,"commitSha":55,"skillDirectory":56,"forksCount":57,"repositoryHtmlUrl":58,"repositoryHomepageUrl":6,"ownerHtmlUrl":59,"ownerBlogUrl":60,"ownerDescription":6,"updatedAt":61,"install":62,"resources":75},"01M6KC1PS7JKS8XK5ERT4M1VEN","qms-audit-expert",null,"ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.","afaizalam2003\u002FMaster-claude-skill","afaizalam2003","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F222019359?v=4","01M6K8F2XNT0HKBPF00JQ78SV3","Faiz Alam","01M6K8F31EBXAPER0EG8R9HTR5",3,"MIT","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fqms-audit-expert\u002FSKILL.md",[],[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38],"audit","qms audit expert","expert","expertise","planning","preparation","for","prep","internal audit","audit preparation","ISO 13485","medical","iso","checklist","use","management","schedule","classification","execution","verification","2026-11-10 10:12:30",false,"---\nname: \"qms-audit-expert\"\ndescription: ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.\ntriggers:\n  - ISO 13485 audit\n  - internal audit\n  - QMS audit\n  - audit planning\n  - nonconformity classification\n  - CAPA verification\n  - audit checklist\n  - audit finding\n  - external audit prep\n  - audit schedule\n---\n\n# QMS Audit Expert\n\nISO 13485 internal audit methodology for medical device quality management systems.\n\n---\n\n## Table of Contents\n\n- [Audit Planning Workflow](#audit-planning-workflow)\n- [Audit Execution](#audit-execution)\n- [Nonconformity Management](#nonconformity-management)\n- [External Audit Preparation](#external-audit-preparation)\n- [Reference Documentation](#reference-documentation)\n- [Tools](#tools)\n\n---\n\n## Audit Planning Workflow\n\nPlan risk-based internal audit program:\n\n1. List all QMS processes requiring audit\n2. Assign risk level to each process (High\u002FMedium\u002FLow)\n3. Review previous audit findings and trends\n4. Determine audit frequency by risk level\n5. Assign qualified auditors (verify independence)\n6. Create annual audit schedule\n7. Communicate schedule to process owners\n8. **Validation:** All ISO 13485 clauses covered within cycle\n\n### Risk-Based Audit Frequency\n\n| Risk Level | Frequency | Criteria |\n|------------|-----------|----------|\n| High | Quarterly | Design control, CAPA, production validation |\n| Medium | Semi-annual | Purchasing, training, document control |\n| Low | Annual | Infrastructure, management review (if stable) |\n\n### Audit Scope by Clause\n\n| Clause | Process | Focus Areas |\n|--------|---------|-------------|\n| 4.2 | Document Control | Document approval, distribution, obsolete control |\n| 5.6 | Management Review | Inputs complete, decisions documented, actions tracked |\n| 6.2 | Training | Competency defined, records complete, effectiveness verified |\n| 7.3 | Design Control | Inputs, reviews, V&V, transfer, changes |\n| 7.4 | Purchasing | Supplier evaluation, incoming inspection |\n| 7.5 | Production | Work instructions, process validation, DHR |\n| 7.6 | Calibration | Equipment list, calibration status, out-of-tolerance |\n| 8.2.2 | Internal Audit | Schedule compliance, auditor independence |\n| 8.3 | NC Product | Identification, segregation, disposition |\n| 8.5 | CAPA | Root cause, implementation, effectiveness |\n\n### Auditor Independence\n\nVerify auditor independence before assignment:\n\n- [ ] Auditor not responsible for area being audited\n- [ ] No direct reporting relationship to auditee\n- [ ] Not involved in recent activities under audit\n- [ ] Documented qualification for audit scope\n\n---\n\n## Audit Execution\n\nConduct systematic internal audit:\n\n1. Prepare audit plan (scope, criteria, schedule)\n2. Review relevant documentation before audit\n3. Conduct opening meeting with auditee\n4. Collect evidence (records, interviews, observation)\n5. Classify findings (Major\u002FMinor\u002FObservation)\n6. Conduct closing meeting with preliminary findings\n7. Prepare audit report within 5 business days\n8. **Validation:** All scope items covered, findings supported by evidence\n\n### Evidence Collection\n\n| Method | Use For | Documentation |\n|--------|---------|---------------|\n| Document review | Procedures, records | Document number, version, date |\n| Interview | Process understanding | Interviewee name, role, summary |\n| Observation | Actual practice | What, where, when observed |\n| Record trace | Process flow | Record IDs, dates, linkage |\n\n### Audit Questions by Clause\n\n**Document Control (4.2):**\n- Show me the document master list\n- How do you control obsolete documents?\n- Show me evidence of document change approval\n\n**Design Control (7.3):**\n- Show me the Design History File for [product]\n- Who participates in design reviews?\n- Show me design input to output traceability\n\n**CAPA (8.5):**\n- Show me the CAPA log with open items\n- How do you determine root cause?\n- Show me effectiveness verification records\n\nSee `references\u002Fiso13485-audit-guide.md` for complete question sets.\n\n### Finding Documentation\n\nDocument each finding with:\n\n```\nRequirement: [Specific ISO 13485 clause or procedure]\nEvidence: [What was observed, reviewed, or heard]\nGap: [How evidence fails to meet requirement]\n```\n\n**Example:**\n```\nRequirement: ISO 13485:2016 Clause 7.6 requires calibration\nat specified intervals.\n\nEvidence: Calibration records for pH meter (EQ-042) show\nlast calibration 2024-01-15. Calibration interval is\n12 months. Today is 2025-03-20.\n\nGap: Equipment is 2 months overdue for calibration,\nrepresenting a gap in calibration program execution.\n```\n\n---\n\n## Nonconformity Management\n\nClassify and manage audit findings:\n\n1. Evaluate finding against classification criteria\n2. Assign severity (Major\u002FMinor\u002FObservation)\n3. Document finding with objective evidence\n4. Communicate to process owner\n5. Initiate CAPA for Major\u002FMinor findings\n6. Track to closure\n7. Verify effectiveness at follow-up\n8. **Validation:** Finding closed only after effective CAPA\n\n### Classification Criteria\n\n| Category | Definition | CAPA Required | Timeline |\n|----------|------------|---------------|----------|\n| Major | Systematic failure or absence of element | Yes | 30 days |\n| Minor | Isolated lapse or partial implementation | Recommended | 60 days |\n| Observation | Improvement opportunity | Optional | As appropriate |\n\n### Classification Decision\n\n```\nIs required element absent or failed?\n├── Yes → Systematic (multiple instances)? → MAJOR\n│   └── No → Could affect product safety? → MAJOR\n│       └── No → MINOR\n└── No → Deviation from procedure?\n    ├── Yes → Recurring? → MAJOR\n    │   └── No → MINOR\n    └── No → Improvement opportunity? → OBSERVATION\n```\n\n### CAPA Integration\n\n| Finding Severity | CAPA Depth | Verification |\n|------------------|------------|--------------|\n| Major | Full root cause analysis (5-Why, Fishbone) | Next audit or within 6 months |\n| Minor | Immediate cause identification | Next scheduled audit |\n| Observation | Not required | Noted at next audit |\n\nSee `references\u002Fnonconformity-classification.md` for detailed guidance.\n\n---\n\n## External Audit Preparation\n\nPrepare for certification body or regulatory audit:\n\n1. Complete all scheduled internal audits\n2. Verify all findings closed with effective CAPA\n3. Review documentation for currency and accuracy\n4. Conduct management review with audit as input\n5. Prepare facility and personnel\n6. Conduct mock audit (full scope)\n7. Brief personnel on audit protocol\n8. **Validation:** Mock audit findings addressed before external audit\n\n### Pre-Audit Readiness Checklist\n\n**Documentation:**\n- [ ] Quality Manual current\n- [ ] Procedures reflect actual practice\n- [ ] Records complete and retrievable\n- [ ] Previous audit findings closed\n\n**Personnel:**\n- [ ] Key personnel available during audit\n- [ ] Subject matter experts identified\n- [ ] Personnel briefed on audit protocol\n- [ ] Escorts assigned\n\n**Facility:**\n- [ ] Work areas organized\n- [ ] Documents at point of use current\n- [ ] Equipment calibration status visible\n- [ ] Nonconforming product segregated\n\n### Mock Audit Protocol\n\n1. Use external auditor or qualified internal auditor\n2. Cover full scope of upcoming external audit\n3. Simulate actual audit conditions (timing, formality)\n4. Document findings as for real audit\n5. Address all Major and Minor findings before external audit\n6. Brief management on readiness status\n\n---\n\n## Reference Documentation\n\n### ISO 13485 Audit Guide\n\n`references\u002Fiso13485-audit-guide.md` contains:\n\n- Clause-by-clause audit methodology\n- Sample audit questions for each clause\n- Evidence collection requirements\n- Common nonconformities by clause\n- Finding severity classification\n\n### Nonconformity Classification\n\n`references\u002Fnonconformity-classification.md` contains:\n\n- Severity classification criteria and decision tree\n- Impact vs. occurrence matrix\n- CAPA integration requirements\n- Finding documentation templates\n- Closure requirements by severity\n\n---\n\n## Tools\n\n### Audit Schedule Optimizer\n\n```bash\n# Generate optimized audit schedule\npython scripts\u002Faudit_schedule_optimizer.py --processes processes.json\n\n# Interactive mode\npython scripts\u002Faudit_schedule_optimizer.py --interactive\n\n# JSON output for integration\npython scripts\u002Faudit_schedule_optimizer.py --processes processes.json --output json\n```\n\nGenerates risk-based audit schedule considering:\n- Process risk level\n- Previous findings\n- Days since last audit\n- Criticality scores\n\n**Output includes:**\n- Prioritized audit schedule\n- Quarterly distribution\n- Overdue audit alerts\n- Resource recommendations\n\n### Sample Process Input\n\n```json\n{\n  \"processes\": [\n    {\n      \"name\": \"Design Control\",\n      \"iso_clause\": \"7.3\",\n      \"risk_level\": \"HIGH\",\n      \"last_audit_date\": \"2024-06-15\",\n      \"previous_findings\": 2\n    },\n    {\n      \"name\": \"Document Control\",\n      \"iso_clause\": \"4.2\",\n      \"risk_level\": \"MEDIUM\",\n      \"last_audit_date\": \"2024-09-01\",\n      \"previous_findings\": 0\n    }\n  ]\n}\n```\n\n---\n\n## Audit Program Metrics\n\nTrack audit program effectiveness:\n\n| Metric | Target | Measurement |\n|--------|--------|-------------|\n| Schedule compliance | >90% | Audits completed on time |\n| Finding closure rate | >95% | Findings closed by due date |\n| Repeat findings | \u003C10% | Same finding in consecutive audits |\n| CAPA effectiveness | >90% | Verified effective at follow-up |\n| Auditor utilization | 4 days\u002Fmonth | Audit days per qualified auditor |\n","# QMS Audit Expert\n\nISO 13485 internal audit methodology for medical device quality management systems.\n\n---\n\n## Table of Contents\n\n- [Audit Planning Workflow](#audit-planning-workflow)\n- [Audit Execution](#audit-execution)\n- [Nonconformity Management](#nonconformity-management)\n- [External Audit Preparation](#external-audit-preparation)\n- [Reference Documentation](#reference-documentation)\n- [Tools](#tools)\n\n---\n\n## Audit Planning Workflow\n\nPlan risk-based internal audit program:\n\n1. List all QMS processes requiring audit\n2. Assign risk level to each process (High\u002FMedium\u002FLow)\n3. Review previous audit findings and trends\n4. Determine audit frequency by risk level\n5. Assign qualified auditors (verify independence)\n6. Create annual audit schedule\n7. Communicate schedule to process owners\n8. **Validation:** All ISO 13485 clauses covered within cycle\n\n### Risk-Based Audit Frequency\n\n| Risk Level | Frequency | Criteria |\n|------------|-----------|----------|\n| High | Quarterly | Design control, CAPA, production validation |\n| Medium | Semi-annual | Purchasing, training, document control |\n| Low | Annual | Infrastructure, management review (if stable) |\n\n### Audit Scope by Clause\n\n| Clause | Process | Focus Areas |\n|--------|---------|-------------|\n| 4.2 | Document Control | Document approval, distribution, obsolete control |\n| 5.6 | Management Review | Inputs complete, decisions documented, actions tracked |\n| 6.2 | Training | Competency defined, records complete, effectiveness verified |\n| 7.3 | Design Control | Inputs, reviews, V&V, transfer, changes |\n| 7.4 | Purchasing | Supplier evaluation, incoming inspection |\n| 7.5 | Production | Work instructions, process validation, DHR |\n| 7.6 | Calibration | Equipment list, calibration status, out-of-tolerance |\n| 8.2.2 | Internal Audit | Schedule compliance, auditor independence |\n| 8.3 | NC Product | Identification, segregation, disposition |\n| 8.5 | CAPA | Root cause, implementation, effectiveness |\n\n### Auditor Independence\n\nVerify auditor independence before assignment:\n\n- [ ] Auditor not responsible for area being audited\n- [ ] No direct reporting relationship to auditee\n- [ ] Not involved in recent activities under audit\n- [ ] Documented qualification for audit scope\n\n---\n\n## Audit Execution\n\nConduct systematic internal audit:\n\n1. Prepare audit plan (scope, criteria, schedule)\n2. Review relevant documentation before audit\n3. Conduct opening meeting with auditee\n4. Collect evidence (records, interviews, observation)\n5. Classify findings (Major\u002FMinor\u002FObservation)\n6. Conduct closing meeting with preliminary findings\n7. Prepare audit report within 5 business days\n8. **Validation:** All scope items covered, findings supported by evidence\n\n### Evidence Collection\n\n| Method | Use For | Documentation |\n|--------|---------|---------------|\n| Document review | Procedures, records | Document number, version, date |\n| Interview | Process understanding | Interviewee name, role, summary |\n| Observation | Actual practice | What, where, when observed |\n| Record trace | Process flow | Record IDs, dates, linkage |\n\n### Audit Questions by Clause\n\n**Document Control (4.2):**\n- Show me the document master list\n- How do you control obsolete documents?\n- Show me evidence of document change approval\n\n**Design Control (7.3):**\n- Show me the Design History File for [product]\n- Who participates in design reviews?\n- Show me design input to output traceability\n\n**CAPA (8.5):**\n- Show me the CAPA log with open items\n- How do you determine root cause?\n- Show me effectiveness verification records\n\nSee `references\u002Fiso13485-audit-guide.md` for complete question sets.\n\n### Finding Documentation\n\nDocument each finding with:\n\n```\nRequirement: [Specific ISO 13485 clause or procedure]\nEvidence: [What was observed, reviewed, or heard]\nGap: [How evidence fails to meet requirement]\n```\n\n**Example:**\n```\nRequirement: ISO 13485:2016 Clause 7.6 requires calibration\nat specified intervals.\n\nEvidence: Calibration records for pH meter (EQ-042) show\nlast calibration 2024-01-15. Calibration interval is\n12 months. Today is 2025-03-20.\n\nGap: Equipment is 2 months overdue for calibration,\nrepresenting a gap in calibration program execution.\n```\n\n---\n\n## Nonconformity Management\n\nClassify and manage audit findings:\n\n1. Evaluate finding against classification criteria\n2. Assign severity (Major\u002FMinor\u002FObservation)\n3. Document finding with objective evidence\n4. Communicate to process owner\n5. Initiate CAPA for Major\u002FMinor findings\n6. Track to closure\n7. Verify effectiveness at follow-up\n8. **Validation:** Finding closed only after effective CAPA\n\n### Classification Criteria\n\n| Category | Definition | CAPA Required | Timeline |\n|----------|------------|---------------|----------|\n| Major | Systematic failure or absence of element | Yes | 30 days |\n| Minor | Isolated lapse or partial implementation | Recommended | 60 days |\n| Observation | Improvement opportunity | Optional | As appropriate |\n\n### Classification Decision\n\n```\nIs required element absent or failed?\n├── Yes → Systematic (multiple instances)? → MAJOR\n│   └── No → Could affect product safety? → MAJOR\n│       └── No → MINOR\n└── No → Deviation from procedure?\n    ├── Yes → Recurring? → MAJOR\n    │   └── No → MINOR\n    └── No → Improvement opportunity? → OBSERVATION\n```\n\n### CAPA Integration\n\n| Finding Severity | CAPA Depth | Verification |\n|------------------|------------|--------------|\n| Major | Full root cause analysis (5-Why, Fishbone) | Next audit or within 6 months |\n| Minor | Immediate cause identification | Next scheduled audit |\n| Observation | Not required | Noted at next audit |\n\nSee `references\u002Fnonconformity-classification.md` for detailed guidance.\n\n---\n\n## External Audit Preparation\n\nPrepare for certification body or regulatory audit:\n\n1. Complete all scheduled internal audits\n2. Verify all findings closed with effective CAPA\n3. Review documentation for currency and accuracy\n4. Conduct management review with audit as input\n5. Prepare facility and personnel\n6. Conduct mock audit (full scope)\n7. Brief personnel on audit protocol\n8. **Validation:** Mock audit findings addressed before external audit\n\n### Pre-Audit Readiness Checklist\n\n**Documentation:**\n- [ ] Quality Manual current\n- [ ] Procedures reflect actual practice\n- [ ] Records complete and retrievable\n- [ ] Previous audit findings closed\n\n**Personnel:**\n- [ ] Key personnel available during audit\n- [ ] Subject matter experts identified\n- [ ] Personnel briefed on audit protocol\n- [ ] Escorts assigned\n\n**Facility:**\n- [ ] Work areas organized\n- [ ] Documents at point of use current\n- [ ] Equipment calibration status visible\n- [ ] Nonconforming product segregated\n\n### Mock Audit Protocol\n\n1. Use external auditor or qualified internal auditor\n2. Cover full scope of upcoming external audit\n3. Simulate actual audit conditions (timing, formality)\n4. Document findings as for real audit\n5. Address all Major and Minor findings before external audit\n6. Brief management on readiness status\n\n---\n\n## Reference Documentation\n\n### ISO 13485 Audit Guide\n\n`references\u002Fiso13485-audit-guide.md` contains:\n\n- Clause-by-clause audit methodology\n- Sample audit questions for each clause\n- Evidence collection requirements\n- Common nonconformities by clause\n- Finding severity classification\n\n### Nonconformity Classification\n\n`references\u002Fnonconformity-classification.md` contains:\n\n- Severity classification criteria and decision tree\n- Impact vs. occurrence matrix\n- CAPA integration requirements\n- Finding documentation templates\n- Closure requirements by severity\n\n---\n\n## Tools\n\n### Audit Schedule Optimizer\n\n```bash\n# Generate optimized audit schedule\npython scripts\u002Faudit_schedule_optimizer.py --processes processes.json\n\n# Interactive mode\npython scripts\u002Faudit_schedule_optimizer.py --interactive\n\n# JSON output for integration\npython scripts\u002Faudit_schedule_optimizer.py --processes processes.json --output json\n```\n\nGenerates risk-based audit schedule considering:\n- Process risk level\n- Previous findings\n- Days since last audit\n- Criticality scores\n\n**Output includes:**\n- Prioritized audit schedule\n- Quarterly distribution\n- Overdue audit alerts\n- Resource recommendations\n\n### Sample Process Input\n\n```json\n{\n  \"processes\": [\n    {\n      \"name\": \"Design Control\",\n      \"iso_clause\": \"7.3\",\n      \"risk_level\": \"HIGH\",\n      \"last_audit_date\": \"2024-06-15\",\n      \"previous_findings\": 2\n    },\n    {\n      \"name\": \"Document Control\",\n      \"iso_clause\": \"4.2\",\n      \"risk_level\": \"MEDIUM\",\n      \"last_audit_date\": \"2024-09-01\",\n      \"previous_findings\": 0\n    }\n  ]\n}\n```\n\n---\n\n## Audit Program Metrics\n\nTrack audit program effectiveness:\n\n| Metric | Target | Measurement |\n|--------|--------|-------------|\n| Schedule compliance | >90% | Audits completed on time |\n| Finding closure rate | >95% | Findings closed by due date |\n| Repeat findings | \u003C10% | Same finding in consecutive audits |\n| CAPA effectiveness | >90% | Verified effective at follow-up |\n| Auditor utilization | 4 days\u002Fmonth | Audit days per qualified auditor |\n",{"name":5,"triggers":44,"description":7},[45,27,46,47,48,49,50,51,52,53],"ISO 13485 audit","QMS audit","audit planning","nonconformity classification","CAPA verification","audit checklist","audit finding","external audit prep","audit schedule","main","0b48cbb0e6d5be6ff68c0f6b28bc0c65ee21c4a1","ra-qm-team\u002Fqms-audit-expert",2,"https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill","https:\u002F\u002Fgithub.com\u002Fafaizalam2003","https:\u002F\u002Fwww.linkedin.com\u002Fin\u002Fmdfaizalam2003\u002F","2026-04-01 04:35:43",{"source":8,"skillName":5,"commands":63,"prompt":73,"zipAvailable":74},[64,67,70],{"tool":65,"command":66},"npx","npx skills add afaizalam2003\u002FMaster-claude-skill --skill 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when the user asks to prepare for SOC 2 audits, map Trust Service Criteria, build control matrices, collect audit evidence, perform gap analysis, or assess SOC 2 Type I vs Type II readiness.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fsoc2-compliance\u002FSKILL.md",[99],{"categoryNo":100,"categoryName":101,"taxonomyType":102,"taxonomyTypeDesc":103},"01JBSEEDCAT000000000000037","律师与法务","PROFESSION","适用职业",[105,106,107,108,19,109,110,111,33,112,113,114,115,116,117,118,119,120,121,25],"compliance","soc2","soc2 compliance","audit evidence","collect","soc","analysis","evidence","trust","build","map","control","type","gap","readiness","gap 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Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Frisk-management-specialist\u002FSKILL.md",[],[129,130,34,131,132,133,134,135,111,33,136,31,30,137,138,139,140,141,142,143],"risk","risk management specialist","risk management","risk evaluation","product","Evaluation","lifecycle","risk matrix","iso 14971","identification","information","post-production","tree","matrix","implementing",{"skillNo":145,"name":146,"nameZh":6,"description":147,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":148,"categories":149,"keywords":150,"publishedAt":39},"01M6KC3HF5ZFSSP2NZF68PEPFB","regulatory-affairs-head","Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017\u002F745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md",[],[151,152,153,154,155,156,157,158,159,33,160,161,162,163,164,165,166,167,168,25],"regulatory affairs head","regulatory","head","documents","devices","health","plan","write","strategy","standards","queries","manage","strategies","de","users","respond","medical devices","manager",{"skillNo":170,"name":171,"nameZh":6,"description":172,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":173,"categories":174,"keywords":183,"publishedAt":39},"01M6KC34Z8M1559EY1CXYBJB1A","quality-manager-qms-iso13485","ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qms-iso13485\u002FSKILL.md",[175,180],{"categoryNo":176,"categoryName":177,"taxonomyType":178,"taxonomyTypeDesc":179},"01JBSEEDCAT000000000000015","视觉设计","SCENARIO","使用场景",{"categoryNo":181,"categoryName":182,"taxonomyType":102,"taxonomyTypeDesc":103},"01JBSEEDCAT000000000000032","设计师",[184,185,168,186,187,188,189,190,191,33,192,193,194,195,29,196,197,27,25,24],"quality manager qms iso13485","quality","design","workflows","validation","actions","certification","system","maintenance","document","systems","records","organizations","corrective action",{"skillNo":199,"name":200,"nameZh":6,"description":201,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":202,"categories":203,"keywords":205,"publishedAt":39},"01M6KC2FXHBHXYX2ZZ17Y3GDB4","quality-manager-qmr","Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qmr\u002FSKILL.md",[204],{"categoryNo":100,"categoryName":101,"taxonomyType":102,"taxonomyTypeDesc":103},[206,185,168,207,208,209,210,211,105,212,191,213,152,214,215,216,31,29,25,217],"quality manager qmr","review","policy","performance","governance","monitoring","regulatory compliance","oversight","cost","culture","leadership","person",{"skillNo":219,"name":220,"nameZh":6,"description":221,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":222,"categories":223,"keywords":231,"publishedAt":39},"01M6KC1VRR5JTDBNZANHPS6VR6","quality-documentation-manager","Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-documentation-manager\u002FSKILL.md",[224,227,230],{"categoryNo":225,"categoryName":226,"taxonomyType":178,"taxonomyTypeDesc":179},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":228,"categoryName":229,"taxonomyType":178,"taxonomyTypeDesc":179},"01JBSEEDCAT000000000000023","Skill与智能体开发",{"categoryNo":100,"categoryName":101,"taxonomyType":102,"taxonomyTypeDesc":103},[232,233,185,168,207,234,235,19,191,236,237,238,239,240,30,241,242,243,244,25],"documentation","quality documentation manager","workflow","change","change management","list","master","system management","documentation review","cfr","21 cfr part 11","change control","retention"]