[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6EKEAHFSKV35F3CBFQWQDTC":3,"skill-same:01M6EKEAHFSKV35F3CBFQWQDTC":100},{"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":22,"publishedAt":38,"linkOnly":39,"markdownContent":40,"markdownBody":41,"frontMatter":42,"refName":43,"commitSha":44,"skillDirectory":45,"forksCount":46,"repositoryHtmlUrl":47,"repositoryHomepageUrl":6,"ownerHtmlUrl":48,"ownerBlogUrl":6,"ownerDescription":6,"updatedAt":49,"install":50,"resources":63},"01M6EKEAHFSKV35F3CBFQWQDTC","fda-consultant-specialist",null,"FDA regulatory consultant for medical device companies. Provides 510(k)\u002FPMA\u002FDe Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.","ArogyaReddy\u002Falirezarezvani-claude-skills","ArogyaReddy","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F12032101?v=4","01M6EJA7DAM8950XYAD875F4NY","01M6EJA7JSMD9SN617EJHTF2BQ",39,"MIT","https:\u002F\u002Fgithub.com\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Ffda-consultant-specialist\u002FSKILL.md",[17],{"categoryNo":18,"categoryName":19,"taxonomyType":20,"taxonomyTypeDesc":21},"01JBSEEDCAT000000000000037","律师与法务","PROFESSION","适用职业",[23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"fda consultant specialist","fda","consultant","cybersecurity","compliance","hipaa","user","use","regulatory","guidance","device","medical","cfr","pathway","de","2026-11-10 10:12:30",false,"---\nname: \"fda-consultant-specialist\"\ndescription: FDA regulatory consultant for medical device companies. Provides 510(k)\u002FPMA\u002FDe Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.\n---\n\n# FDA Consultant Specialist\n\nFDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.\n\n## Table of Contents\n\n- [FDA Pathway Selection](#fda-pathway-selection)\n- [510(k) Submission Process](#510k-submission-process)\n- [QSR Compliance](#qsr-compliance)\n- [HIPAA for Medical Devices](#hipaa-for-medical-devices)\n- [Device Cybersecurity](#device-cybersecurity)\n- [Resources](#resources)\n\n---\n\n## FDA Pathway Selection\n\nDetermine the appropriate FDA regulatory pathway based on device classification and predicate availability.\n\n### Decision Framework\n\n```\nPredicate device exists?\n├── YES → Substantially equivalent?\n│   ├── YES → 510(k) Pathway\n│   │   ├── No design changes → Abbreviated 510(k)\n│   │   ├── Manufacturing only → Special 510(k)\n│   │   └── Design\u002Fperformance → Traditional 510(k)\n│   └── NO → PMA or De Novo\n└── NO → Novel device?\n    ├── Low-to-moderate risk → De Novo\n    └── High risk (Class III) → PMA\n```\n\n### Pathway Comparison\n\n| Pathway | When to Use | Timeline | Cost |\n|---------|-------------|----------|------|\n| 510(k) Traditional | Predicate exists, design changes | 90 days | $21,760 |\n| 510(k) Special | Manufacturing changes only | 30 days | $21,760 |\n| 510(k) Abbreviated | Guidance\u002Fstandard conformance | 30 days | $21,760 |\n| De Novo | Novel, low-moderate risk | 150 days | $134,676 |\n| PMA | Class III, no predicate | 180+ days | $425,000+ |\n\n### Pre-Submission Strategy\n\n1. Identify product code and classification\n2. Search 510(k) database for predicates\n3. Assess substantial equivalence feasibility\n4. Prepare Q-Sub questions for FDA\n5. Schedule Pre-Sub meeting if needed\n\n**Reference:** See [fda_submission_guide.md](references\u002Ffda_submission_guide.md) for pathway decision matrices and submission requirements.\n\n---\n\n## 510(k) Submission Process\n\n### Workflow\n\n```\nPhase 1: Planning\n├── Step 1: Identify predicate device(s)\n├── Step 2: Compare intended use and technology\n├── Step 3: Determine testing requirements\n└── Checkpoint: SE argument feasible?\n\nPhase 2: Preparation\n├── Step 4: Complete performance testing\n├── Step 5: Prepare device description\n├── Step 6: Document SE comparison\n├── Step 7: Finalize labeling\n└── Checkpoint: All required sections complete?\n\nPhase 3: Submission\n├── Step 8: Assemble submission package\n├── Step 9: Submit via eSTAR\n├── Step 10: Track acknowledgment\n└── Checkpoint: Submission accepted?\n\nPhase 4: Review\n├── Step 11: Monitor review status\n├── Step 12: Respond to AI requests\n├── Step 13: Receive decision\n└── Verification: SE letter received?\n```\n\n### Required Sections (21 CFR 807.87)\n\n| Section | Content |\n|---------|---------|\n| Cover Letter | Submission type, device ID, contact info |\n| Form 3514 | CDRH premarket review cover sheet |\n| Device Description | Physical description, principles of operation |\n| Indications for Use | Form 3881, patient population, use environment |\n| SE Comparison | Side-by-side comparison with predicate |\n| Performance Testing | Bench, biocompatibility, electrical safety |\n| Software Documentation | Level of concern, hazard analysis (IEC 62304) |\n| Labeling | IFU, package labels, warnings |\n| 510(k) Summary | Public summary of submission |\n\n### Common RTA Issues\n\n| Issue | Prevention |\n|-------|------------|\n| Missing user fee | Verify payment before submission |\n| Incomplete Form 3514 | Review all fields, ensure signature |\n| No predicate identified | Confirm K-number in FDA database |\n| Inadequate SE comparison | Address all technological characteristics |\n\n---\n\n## QSR Compliance\n\nQuality System Regulation (21 CFR Part 820) requirements for medical device manufacturers.\n\n### Key Subsystems\n\n| Section | Title | Focus |\n|---------|-------|-------|\n| 820.20 | Management Responsibility | Quality policy, org structure, management review |\n| 820.30 | Design Controls | Input, output, review, verification, validation |\n| 820.40 | Document Controls | Approval, distribution, change control |\n| 820.50 | Purchasing Controls | Supplier qualification, purchasing data |\n| 820.70 | Production Controls | Process validation, environmental controls |\n| 820.100 | CAPA | Root cause analysis, corrective actions |\n| 820.181 | Device Master Record | Specifications, procedures, acceptance criteria |\n\n### Design Controls Workflow (820.30)\n\n```\nStep 1: Design Input\n└── Capture user needs, intended use, regulatory requirements\n    Verification: Inputs reviewed and approved?\n\nStep 2: Design Output\n└── Create specifications, drawings, software architecture\n    Verification: Outputs traceable to inputs?\n\nStep 3: Design Review\n└── Conduct reviews at each phase milestone\n    Verification: Review records with signatures?\n\nStep 4: Design Verification\n└── Perform testing against specifications\n    Verification: All tests pass acceptance criteria?\n\nStep 5: Design Validation\n└── Confirm device meets user needs in actual use conditions\n    Verification: Validation report approved?\n\nStep 6: Design Transfer\n└── Release to production with DMR complete\n    Verification: Transfer checklist complete?\n```\n\n### CAPA Process (820.100)\n\n1. **Identify**: Document nonconformity or potential problem\n2. **Investigate**: Perform root cause analysis (5 Whys, Fishbone)\n3. **Plan**: Define corrective\u002Fpreventive actions\n4. **Implement**: Execute actions, update documentation\n5. **Verify**: Confirm implementation complete\n6. **Effectiveness**: Monitor for recurrence (30-90 days)\n7. **Close**: Management approval and closure\n\n**Reference:** See [qsr_compliance_requirements.md](references\u002Fqsr_compliance_requirements.md) for detailed QSR implementation guidance.\n\n---\n\n## HIPAA for Medical Devices\n\nHIPAA requirements for devices that create, store, transmit, or access Protected Health Information (PHI).\n\n### Applicability\n\n| Device Type | HIPAA Applies |\n|-------------|---------------|\n| Standalone diagnostic (no data transmission) | No |\n| Connected device transmitting patient data | Yes |\n| Device with EHR integration | Yes |\n| SaMD storing patient information | Yes |\n| Wellness app (no diagnosis) | Only if stores PHI |\n\n### Required Safeguards\n\n```\nAdministrative (§164.308)\n├── Security officer designation\n├── Risk analysis and management\n├── Workforce training\n├── Incident response procedures\n└── Business associate agreements\n\nPhysical (§164.310)\n├── Facility access controls\n├── Workstation security\n└── Device disposal procedures\n\nTechnical (§164.312)\n├── Access control (unique IDs, auto-logoff)\n├── Audit controls (logging)\n├── Integrity controls (checksums, hashes)\n├── Authentication (MFA recommended)\n└── Transmission security (TLS 1.2+)\n```\n\n### Risk Assessment Steps\n\n1. Inventory all systems handling ePHI\n2. Document data flows (collection, storage, transmission)\n3. Identify threats and vulnerabilities\n4. Assess likelihood and impact\n5. Determine risk levels\n6. Implement controls\n7. Document residual risk\n\n**Reference:** See [hipaa_compliance_framework.md](references\u002Fhipaa_compliance_framework.md) for implementation checklists and BAA templates.\n\n---\n\n## Device Cybersecurity\n\nFDA cybersecurity requirements for connected medical devices.\n\n### Premarket Requirements\n\n| Element | Description |\n|---------|-------------|\n| Threat Model | STRIDE analysis, attack trees, trust boundaries |\n| Security Controls | Authentication, encryption, access control |\n| SBOM | Software Bill of Materials (CycloneDX or SPDX) |\n| Security Testing | Penetration testing, vulnerability scanning |\n| Vulnerability Plan | Disclosure process, patch management |\n\n### Device Tier Classification\n\n**Tier 1 (Higher Risk):**\n- Connects to network\u002Finternet\n- Cybersecurity incident could cause patient harm\n\n**Tier 2 (Standard Risk):**\n- All other connected devices\n\n### Postmarket Obligations\n\n1. Monitor NVD and ICS-CERT for vulnerabilities\n2. Assess applicability to device components\n3. Develop and test patches\n4. Communicate with customers\n5. Report to FDA per guidance\n\n### Coordinated Vulnerability Disclosure\n\n```\nResearcher Report\n    ↓\nAcknowledgment (48 hours)\n    ↓\nInitial Assessment (5 days)\n    ↓\nFix Development\n    ↓\nCoordinated Public Disclosure\n```\n\n**Reference:** See [device_cybersecurity_guidance.md](references\u002Fdevice_cybersecurity_guidance.md) for SBOM format examples and threat modeling templates.\n\n---\n\n## Resources\n\n### scripts\u002F\n\n| Script | Purpose |\n|--------|---------|\n| `fda_submission_tracker.py` | Track 510(k)\u002FPMA\u002FDe Novo submission milestones and timelines |\n| `qsr_compliance_checker.py` | Assess 21 CFR 820 compliance against project documentation |\n| `hipaa_risk_assessment.py` | Evaluate HIPAA safeguards in medical device software |\n\n### references\u002F\n\n| File | Content |\n|------|---------|\n| `fda_submission_guide.md` | 510(k), De Novo, PMA submission requirements and checklists |\n| `qsr_compliance_requirements.md` | 21 CFR 820 implementation guide with templates |\n| `hipaa_compliance_framework.md` | HIPAA Security Rule safeguards and BAA requirements |\n| `device_cybersecurity_guidance.md` | FDA cybersecurity requirements, SBOM, threat modeling |\n| `fda_capa_requirements.md` | CAPA process, root cause analysis, effectiveness verification |\n\n### Usage Examples\n\n```bash\n# Track FDA submission status\npython scripts\u002Ffda_submission_tracker.py \u002Fpath\u002Fto\u002Fproject --type 510k\n\n# Assess QSR compliance\npython scripts\u002Fqsr_compliance_checker.py \u002Fpath\u002Fto\u002Fproject --section 820.30\n\n# Run HIPAA risk assessment\npython scripts\u002Fhipaa_risk_assessment.py \u002Fpath\u002Fto\u002Fproject --category technical\n```\n","# FDA Consultant Specialist\n\nFDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (QSR), HIPAA compliance, and device cybersecurity requirements.\n\n## Table of Contents\n\n- [FDA Pathway Selection](#fda-pathway-selection)\n- [510(k) Submission Process](#510k-submission-process)\n- [QSR Compliance](#qsr-compliance)\n- [HIPAA for Medical Devices](#hipaa-for-medical-devices)\n- [Device Cybersecurity](#device-cybersecurity)\n- [Resources](#resources)\n\n---\n\n## FDA Pathway Selection\n\nDetermine the appropriate FDA regulatory pathway based on device classification and predicate availability.\n\n### Decision Framework\n\n```\nPredicate device exists?\n├── YES → Substantially equivalent?\n│   ├── YES → 510(k) Pathway\n│   │   ├── No design changes → Abbreviated 510(k)\n│   │   ├── Manufacturing only → Special 510(k)\n│   │   └── Design\u002Fperformance → Traditional 510(k)\n│   └── NO → PMA or De Novo\n└── NO → Novel device?\n    ├── Low-to-moderate risk → De Novo\n    └── High risk (Class III) → PMA\n```\n\n### Pathway Comparison\n\n| Pathway | When to Use | Timeline | Cost |\n|---------|-------------|----------|------|\n| 510(k) Traditional | Predicate exists, design changes | 90 days | $21,760 |\n| 510(k) Special | Manufacturing changes only | 30 days | $21,760 |\n| 510(k) Abbreviated | Guidance\u002Fstandard conformance | 30 days | $21,760 |\n| De Novo | Novel, low-moderate risk | 150 days | $134,676 |\n| PMA | Class III, no predicate | 180+ days | $425,000+ |\n\n### Pre-Submission Strategy\n\n1. Identify product code and classification\n2. Search 510(k) database for predicates\n3. Assess substantial equivalence feasibility\n4. Prepare Q-Sub questions for FDA\n5. Schedule Pre-Sub meeting if needed\n\n**Reference:** See [fda_submission_guide.md](references\u002Ffda_submission_guide.md) for pathway decision matrices and submission requirements.\n\n---\n\n## 510(k) Submission Process\n\n### Workflow\n\n```\nPhase 1: Planning\n├── Step 1: Identify predicate device(s)\n├── Step 2: Compare intended use and technology\n├── Step 3: Determine testing requirements\n└── Checkpoint: SE argument feasible?\n\nPhase 2: Preparation\n├── Step 4: Complete performance testing\n├── Step 5: Prepare device description\n├── Step 6: Document SE comparison\n├── Step 7: Finalize labeling\n└── Checkpoint: All required sections complete?\n\nPhase 3: Submission\n├── Step 8: Assemble submission package\n├── Step 9: Submit via eSTAR\n├── Step 10: Track acknowledgment\n└── Checkpoint: Submission accepted?\n\nPhase 4: Review\n├── Step 11: Monitor review status\n├── Step 12: Respond to AI requests\n├── Step 13: Receive decision\n└── Verification: SE letter received?\n```\n\n### Required Sections (21 CFR 807.87)\n\n| Section | Content |\n|---------|---------|\n| Cover Letter | Submission type, device ID, contact info |\n| Form 3514 | CDRH premarket review cover sheet |\n| Device Description | Physical description, principles of operation |\n| Indications for Use | Form 3881, patient population, use environment |\n| SE Comparison | Side-by-side comparison with predicate |\n| Performance Testing | Bench, biocompatibility, electrical safety |\n| Software Documentation | Level of concern, hazard analysis (IEC 62304) |\n| Labeling | IFU, package labels, warnings |\n| 510(k) Summary | Public summary of submission |\n\n### Common RTA Issues\n\n| Issue | Prevention |\n|-------|------------|\n| Missing user fee | Verify payment before submission |\n| Incomplete Form 3514 | Review all fields, ensure signature |\n| No predicate identified | Confirm K-number in FDA database |\n| Inadequate SE comparison | Address all technological characteristics |\n\n---\n\n## QSR Compliance\n\nQuality System Regulation (21 CFR Part 820) requirements for medical device manufacturers.\n\n### Key Subsystems\n\n| Section | Title | Focus |\n|---------|-------|-------|\n| 820.20 | Management Responsibility | Quality policy, org structure, management review |\n| 820.30 | Design Controls | Input, output, review, verification, validation |\n| 820.40 | Document Controls | Approval, distribution, change control |\n| 820.50 | Purchasing Controls | Supplier qualification, purchasing data |\n| 820.70 | Production Controls | Process validation, environmental controls |\n| 820.100 | CAPA | Root cause analysis, corrective actions |\n| 820.181 | Device Master Record | Specifications, procedures, acceptance criteria |\n\n### Design Controls Workflow (820.30)\n\n```\nStep 1: Design Input\n└── Capture user needs, intended use, regulatory requirements\n    Verification: Inputs reviewed and approved?\n\nStep 2: Design Output\n└── Create specifications, drawings, software architecture\n    Verification: Outputs traceable to inputs?\n\nStep 3: Design Review\n└── Conduct reviews at each phase milestone\n    Verification: Review records with signatures?\n\nStep 4: Design Verification\n└── Perform testing against specifications\n    Verification: All tests pass acceptance criteria?\n\nStep 5: Design Validation\n└── Confirm device meets user needs in actual use conditions\n    Verification: Validation report approved?\n\nStep 6: Design Transfer\n└── Release to production with DMR complete\n    Verification: Transfer checklist complete?\n```\n\n### CAPA Process (820.100)\n\n1. **Identify**: Document nonconformity or potential problem\n2. **Investigate**: Perform root cause analysis (5 Whys, Fishbone)\n3. **Plan**: Define corrective\u002Fpreventive actions\n4. **Implement**: Execute actions, update documentation\n5. **Verify**: Confirm implementation complete\n6. **Effectiveness**: Monitor for recurrence (30-90 days)\n7. **Close**: Management approval and closure\n\n**Reference:** See [qsr_compliance_requirements.md](references\u002Fqsr_compliance_requirements.md) for detailed QSR implementation guidance.\n\n---\n\n## HIPAA for Medical Devices\n\nHIPAA requirements for devices that create, store, transmit, or access Protected Health Information (PHI).\n\n### Applicability\n\n| Device Type | HIPAA Applies |\n|-------------|---------------|\n| Standalone diagnostic (no data transmission) | No |\n| Connected device transmitting patient data | Yes |\n| Device with EHR integration | Yes |\n| SaMD storing patient information | Yes |\n| Wellness app (no diagnosis) | Only if stores PHI |\n\n### Required Safeguards\n\n```\nAdministrative (§164.308)\n├── Security officer designation\n├── Risk analysis and management\n├── Workforce training\n├── Incident response procedures\n└── Business associate agreements\n\nPhysical (§164.310)\n├── Facility access controls\n├── Workstation security\n└── Device disposal procedures\n\nTechnical (§164.312)\n├── Access control (unique IDs, auto-logoff)\n├── Audit controls (logging)\n├── Integrity controls (checksums, hashes)\n├── Authentication (MFA recommended)\n└── Transmission security (TLS 1.2+)\n```\n\n### Risk Assessment Steps\n\n1. Inventory all systems handling ePHI\n2. Document data flows (collection, storage, transmission)\n3. Identify threats and vulnerabilities\n4. Assess likelihood and impact\n5. Determine risk levels\n6. Implement controls\n7. Document residual risk\n\n**Reference:** See [hipaa_compliance_framework.md](references\u002Fhipaa_compliance_framework.md) for implementation checklists and BAA templates.\n\n---\n\n## Device Cybersecurity\n\nFDA cybersecurity requirements for connected medical devices.\n\n### Premarket Requirements\n\n| Element | Description |\n|---------|-------------|\n| Threat Model | STRIDE analysis, attack trees, trust boundaries |\n| Security Controls | Authentication, encryption, access control |\n| SBOM | Software Bill of Materials (CycloneDX or SPDX) |\n| Security Testing | Penetration testing, vulnerability scanning |\n| Vulnerability Plan | Disclosure process, patch management |\n\n### Device Tier Classification\n\n**Tier 1 (Higher Risk):**\n- Connects to network\u002Finternet\n- Cybersecurity incident could cause patient harm\n\n**Tier 2 (Standard Risk):**\n- All other connected devices\n\n### Postmarket Obligations\n\n1. Monitor NVD and ICS-CERT for vulnerabilities\n2. Assess applicability to device components\n3. Develop and test patches\n4. Communicate with customers\n5. Report to FDA per guidance\n\n### Coordinated Vulnerability Disclosure\n\n```\nResearcher Report\n    ↓\nAcknowledgment (48 hours)\n    ↓\nInitial Assessment (5 days)\n    ↓\nFix Development\n    ↓\nCoordinated Public Disclosure\n```\n\n**Reference:** See [device_cybersecurity_guidance.md](references\u002Fdevice_cybersecurity_guidance.md) for SBOM format examples and threat modeling templates.\n\n---\n\n## Resources\n\n### scripts\u002F\n\n| Script | Purpose |\n|--------|---------|\n| `fda_submission_tracker.py` | Track 510(k)\u002FPMA\u002FDe Novo submission milestones and timelines |\n| `qsr_compliance_checker.py` | Assess 21 CFR 820 compliance against project documentation |\n| `hipaa_risk_assessment.py` | Evaluate HIPAA safeguards in medical device software |\n\n### references\u002F\n\n| File | Content |\n|------|---------|\n| `fda_submission_guide.md` | 510(k), De Novo, PMA submission requirements and checklists |\n| `qsr_compliance_requirements.md` | 21 CFR 820 implementation guide with templates |\n| `hipaa_compliance_framework.md` | HIPAA Security Rule safeguards and BAA requirements |\n| `device_cybersecurity_guidance.md` | FDA cybersecurity requirements, SBOM, threat modeling |\n| `fda_capa_requirements.md` | CAPA process, root cause analysis, effectiveness verification |\n\n### Usage Examples\n\n```bash\n# Track FDA submission status\npython scripts\u002Ffda_submission_tracker.py \u002Fpath\u002Fto\u002Fproject --type 510k\n\n# Assess QSR compliance\npython scripts\u002Fqsr_compliance_checker.py \u002Fpath\u002Fto\u002Fproject --section 820.30\n\n# Run HIPAA risk assessment\npython scripts\u002Fhipaa_risk_assessment.py \u002Fpath\u002Fto\u002Fproject --category technical\n```\n",{"name":5,"description":7},"main","dc799ac68cfdc454fc55edaf3f054651f645f738","ra-qm-team\u002Ffda-consultant-specialist",10,"https:\u002F\u002Fgithub.com\u002FArogyaReddy\u002Falirezarezvani-claude-skills","https:\u002F\u002Fgithub.com\u002FArogyaReddy","2026-03-18 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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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Frisk-management-specialist\u002FSKILL.md",[],[108,109,110,111,112,113,114,115,116,117,118,30,119,120,121,122,34,123,124,125],"risk","risk management specialist","management","risk management","risk analysis","risk evaluation","product","Evaluation","Production","lifecycle","analysis","risk matrix","Market","control","iso","iso 14971","identification","post",{"skillNo":127,"name":128,"nameZh":6,"description":129,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":130,"categories":131,"keywords":132,"publishedAt":38},"01M6EKFDZ7KES3X3HH8KBHR9JF","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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md",[],[133,31,134,135,136,137,138,139,140,141,142,143,144,145,34,146,36,37,147,148],"regulatory affairs head","head","documentation","documents","packages","plan","access","write","evidence","standards","intelligence","across","strategies","clinical","respond","medical devices",{"skillNo":150,"name":151,"nameZh":6,"description":152,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":153,"categories":154,"keywords":163,"publishedAt":38},"01M6EKF980P5MQBEQQAKB2JE6V","quality-manager-qms-iso13485","ISO 13485 Quality Management System implementation and maintenance for medical device organizations. 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Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.","https:\u002F\u002Fgithub.com\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qms-iso13485\u002FSKILL.md",[155,160],{"categoryNo":156,"categoryName":157,"taxonomyType":158,"taxonomyTypeDesc":159},"01JBSEEDCAT000000000000015","视觉设计","SCENARIO","使用场景",{"categoryNo":161,"categoryName":162,"taxonomyType":20,"taxonomyTypeDesc":21},"01JBSEEDCAT000000000000032","设计师",[164,165,166,167,168,169,135,170,171,27,172,30,173,174,175,121,122,34,176,177],"quality manager qms iso13485","quality","design","review","support","workflows","audit","actions","system","up","maintenance","document","records","ISO 13485",{"skillNo":179,"name":180,"nameZh":6,"description":181,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":182,"categories":183,"keywords":185,"publishedAt":38},"01M6EKF4ZN8ZJJP3K6FM1WEM85","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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qmr\u002FSKILL.md",[184],{"categoryNo":18,"categoryName":19,"taxonomyType":20,"taxonomyTypeDesc":21},[186,165,167,187,188,189,190,27,191,172,110,192,31,193,194,195,122,177],"quality manager qmr","policy","performance","governance","monitoring","regulatory compliance","oversight","cost","culture","leadership",{"skillNo":197,"name":198,"nameZh":6,"description":199,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":200,"categories":201,"keywords":206,"publishedAt":38},"01M6EKF15YKH2AQB45MH4Y6S08","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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-documentation-manager\u002FSKILL.md",[202,205],{"categoryNo":203,"categoryName":204,"taxonomyType":158,"taxonomyTypeDesc":159},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":18,"categoryName":19,"taxonomyType":20,"taxonomyTypeDesc":21},[135,207,165,167,208,209,170,117,210,172,211,212,213,214,215,34,35,216,217,218],"quality documentation manager","workflow","change","document lifecycle","change management","list","master","system management","documentation review","21 cfr part 11","change control","retention",{"skillNo":220,"name":221,"nameZh":6,"description":222,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":223,"categories":224,"keywords":225,"publishedAt":38},"01M6EKEXQMCQC11A5WR9GEPC4S","qms-audit-expert","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.","https:\u002F\u002Fgithub.com\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fqms-audit-expert\u002FSKILL.md",[],[170,226,227,228,229,230,231,232,110,30,233,33,122,34,177],"qms audit expert","expert","planning","verification","execution","classification","schedule","checklist"]