[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6DRZ1HGFBKJ8CDKA0MMDWS6":3,"skill-same:01M6DRZ1HGFBKJ8CDKA0MMDWS6":85},{"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":35,"linkOnly":36,"markdownContent":37,"markdownBody":38,"frontMatter":39,"refName":48,"commitSha":49,"skillDirectory":50,"forksCount":51,"repositoryHtmlUrl":52,"repositoryHomepageUrl":6,"ownerHtmlUrl":53,"ownerBlogUrl":6,"ownerDescription":6,"updatedAt":54,"install":55,"resources":68},"01M6DRZ1HGFBKJ8CDKA0MMDWS6","org-health-diagnostic",null,"Cross-functional organizational health check combining signals from all C-suite roles. Scores 8 dimensions on a traffic-light scale with drill-down recommendations. Use when assessing overall company health, preparing for board reviews, identifying at-risk functions, or when user mentions org health, health check, or health dashboard.","zhangzhang-111-i\u002Fclaude-skills111","zhangzhang-111-i","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F251344927?v=4","01M6DRBP4NCM1ZCHTT0FW0SQHD","lixiying","01M6DRBPAMFDJSGQ69XPK9KM9J",3,"MIT","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Forg-health-diagnostic\u002FSKILL.md",[],[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34],"health","org health diagnostic","dashboard","risk","check","board","user","use","health check","functions","benchmarks","dimensions","signals","recommendations","roles","drill","2026-11-10 10:12:30",false,"---\nname: \"org-health-diagnostic\"\ndescription: \"Cross-functional organizational health check combining signals from all C-suite roles. Scores 8 dimensions on a traffic-light scale with drill-down recommendations. Use when assessing overall company health, preparing for board reviews, identifying at-risk functions, or when user mentions org health, health check, or health dashboard.\"\nlicense: MIT\nmetadata:\n  version: 1.0.0\n  author: Alireza Rezvani\n  category: c-level\n  domain: organizational-health\n  updated: 2026-03-05\n  python-tools: health_scorer.py\n  frameworks: health-benchmarks\n---\n\n# Org Health Diagnostic\n\nEight dimensions. Traffic lights. Real benchmarks. Surfaces the problems you don't know you have.\n\n## Keywords\norg health, organizational health, health diagnostic, health dashboard, health check, company health, functional health, team health, startup health, health scorecard, health assessment, risk dashboard\n\n## Quick Start\n\n```bash\npython scripts\u002Fhealth_scorer.py        # Guided CLI — enter metrics, get scored dashboard\npython scripts\u002Fhealth_scorer.py --json # Output raw JSON for integration\n```\n\nOr describe your metrics:\n```\n\u002Fhealth [paste your key metrics or answer prompts]\n\u002Fhealth:dimension [financial|revenue|product|engineering|people|ops|security|market]\n```\n\n## The 8 Dimensions\n\n### 1. ? Financial Health (CFO)\n**What it measures:** Can we fund operations and invest in growth?\n\nKey metrics:\n- **Runway** — months at current burn (Green: >12, Yellow: 6-12, Red: \u003C6)\n- **Burn multiple** — net burn \u002F net new ARR (Green: \u003C1.5x, Yellow: 1.5-2.5x, Red: >2.5x)\n- **Gross margin** — SaaS target: >65% (Green: >70%, Yellow: 55-70%, Red: \u003C55%)\n- **MoM growth rate** — contextual by stage (see benchmarks)\n- **Revenue concentration** — top customer % of ARR (Green: \u003C15%, Yellow: 15-25%, Red: >25%)\n\n### 2. ? Revenue Health (CRO)\n**What it measures:** Are customers staying, growing, and recommending us?\n\nKey metrics:\n- **NRR (Net Revenue Retention)** — Green: >110%, Yellow: 100-110%, Red: \u003C100%\n- **Logo churn rate (annualized)** — Green: \u003C5%, Yellow: 5-10%, Red: >10%\n- **Pipeline coverage (next quarter)** — Green: >3x, Yellow: 2-3x, Red: \u003C2x\n- **CAC payback period** — Green: \u003C12 months, Yellow: 12-18, Red: >18 months\n- **Average ACV trend** — directional: growing, flat, declining\n\n### 3. ? Product Health (CPO)\n**What it measures:** Do customers love and use the product?\n\nKey metrics:\n- **NPS** — Green: >40, Yellow: 20-40, Red: \u003C20\n- **DAU\u002FMAU ratio** — engagement proxy (Green: >40%, Yellow: 20-40%, Red: \u003C20%)\n- **Core feature adoption** — % of users using primary value feature (Green: >60%)\n- **Time-to-value** — days from signup to first core action (lower is better)\n- **Customer satisfaction (CSAT)** — Green: >4.2\u002F5, Yellow: 3.5-4.2, Red: \u003C3.5\n\n### 4. ⚙️ Engineering Health (CTO)\n**What it measures:** Can we ship reliably and sustain velocity?\n\nKey metrics:\n- **Deployment frequency** — Green: daily, Yellow: weekly, Red: monthly or less\n- **Change failure rate** — % of deployments causing incidents (Green: \u003C5%, Red: >15%)\n- **Mean time to recovery (MTTR)** — Green: \u003C1 hour, Yellow: 1-4 hours, Red: >4 hours\n- **Tech debt ratio** — % of sprint capacity on debt (Green: \u003C20%, Yellow: 20-35%, Red: >35%)\n- **Incident frequency** — P0\u002FP1 per month (Green: \u003C2, Yellow: 2-5, Red: >5)\n\n### 5. ? People Health (CHRO)\n**What it measures:** Is the team stable, engaged, and growing?\n\nKey metrics:\n- **Regrettable attrition (annualized)** — Green: \u003C10%, Yellow: 10-20%, Red: >20%\n- **Engagement score** — (eNPS or similar; Green: >30, Yellow: 0-30, Red: \u003C0)\n- **Time-to-fill (avg days)** — Green: \u003C45, Yellow: 45-90, Red: >90\n- **Manager-to-IC ratio** — Green: 1:5–1:8, Yellow: 1:3–1:5 or 1:8–1:12, Red: outside\n- **Internal promotion rate** — at least 25-30% of senior roles filled internally\n\n### 6. ? Operational Health (COO)\n**What it measures:** Are we executing our strategy with discipline?\n\nKey metrics:\n- **OKR completion rate** — % of key results hitting target (Green: >70%, Yellow: 50-70%, Red: \u003C50%)\n- **Decision cycle time** — days from decision needed to decision made (Green: \u003C48h, Yellow: 48h-1w)\n- **Meeting effectiveness** — % of meetings with clear outcome (qualitative)\n- **Process maturity** — level 1-5 scale (see COO advisor)\n- **Cross-functional initiative completion** — % on time, on scope\n\n### 7. ? Security Health (CISO)\n**What it measures:** Are we protecting customers and maintaining compliance?\n\nKey metrics:\n- **Security incidents (last 90 days)** — Green: 0, Yellow: 1-2 minor, Red: 1+ major\n- **Compliance status** — certifications current\u002Fin-progress vs. overdue\n- **Vulnerability remediation SLA** — % of critical CVEs patched within SLA (Green: 100%)\n- **Security training completion** — % of team current (Green: >95%)\n- **Pen test recency** — Green: \u003C12 months, Yellow: 12-24, Red: >24 months\n\n### 8. ? Market Health (CMO)\n**What it measures:** Are we winning in the market and growing efficiently?\n\nKey metrics:\n- **CAC trend** — improving, flat, or worsening QoQ\n- **Organic vs paid lead mix** — more organic = healthier (less fragile)\n- **Win rate** — % of qualified opportunities closed-won (Green: >25%, Yellow: 15-25%, Red: \u003C15%)\n- **Competitive win rate** — against primary competitors specifically\n- **Brand NPS** — awareness + preference scores in ICP\n\n---\n\n## Scoring & Traffic Lights\n\nEach dimension is scored 1-10 with traffic light:\n- ? **Green (7-10):** Healthy — maintain and optimize\n- ? **Yellow (4-6):** Watch — trend matters; improving or declining?\n- ? **Red (1-3):** Action required — address within 30 days\n\n**Overall Health Score:**\nWeighted average by company stage (see `references\u002Fhealth-benchmarks.md` for weights).\n\n---\n\n## Dimension Interactions (Why One Problem Creates Another)\n\n| If this dimension is red... | Watch these dimensions next |\n|-----------------------------|----------------------------|\n| Financial Health | People (freeze hiring) → Engineering (freeze infra) → Product (cut scope) |\n| Revenue Health | Financial (cash gap) → People (attrition risk) → Market (lose positioning) |\n| People Health | Engineering (velocity drops) → Product (quality drops) → Revenue (churn rises) |\n| Engineering Health | Product (features slip) → Revenue (deals stall on product) |\n| Product Health | Revenue (NRR drops, churn rises) → Market (CAC rises; referrals dry up) |\n| Operational Health | All dimensions degrade over time (execution failure cascades everywhere) |\n\n---\n\n## Dashboard Output Format\n\n```\nORG HEALTH DIAGNOSTIC — [Company] — [Date]\nStage: [Seed\u002FA\u002FB\u002FC]   Overall: [Score]\u002F10   Trend: [↑ Improving \u002F → Stable \u002F ↓ Declining]\n\nDIMENSION SCORES\n━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━\n? Financial    ? 8.2  Runway 14mo, burn 1.6x — strong\n? Revenue      ? 5.8  NRR 104%, pipeline thin (1.8x coverage)\n? Product      ? 7.4  NPS 42, DAU\u002FMAU 38%\n⚙️  Engineering  ? 5.2  Debt at 30%, MTTR 3.2h\n? People       ? 3.8  Attrition 24%, eng morale low\n? Operations   ? 6.0  OKR 65% completion\n? Security     ? 7.8  SOC 2 Type II complete, 0 incidents\n? Market       ? 5.5  CAC rising, win rate dropped to 22%\n━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━\n\nTOP PRIORITIES\n? [1] People: attrition at 24% — engineering velocity will drop in 60 days\n   Action: CHRO + CEO to run retention audit; target top 5 at-risk this week\n? [2] Revenue: pipeline coverage at 1.8x — Q+1 miss risk is high\n   Action: CRO to add 3 qualified opps within 30 days or shift forecast down\n? [3] Engineering: tech debt at 30% of sprint — shipping will slow by Q3\n   Action: CTO to propose debt sprint plan; COO to protect capacity\n\nWATCH\n→ People → Engineering cascade risk if attrition continues (see dimension interactions)\n```\n\n---\n\n## Graceful Degradation\n\nYou don't need all metrics to run a diagnostic. The tool handles partial data:\n- Missing metric → excluded from score, flagged as \"[data needed]\"\n- Score still valid for available dimensions\n- Report flags which gaps to fill for next cycle\n\n## References\n- `references\u002Fhealth-benchmarks.md` — benchmarks by stage (Seed, A, B, C)\n- `scripts\u002Fhealth_scorer.py` — CLI scoring tool with traffic light output\n","# Org Health Diagnostic\n\nEight dimensions. Traffic lights. Real benchmarks. Surfaces the problems you don't know you have.\n\n## Keywords\norg health, organizational health, health diagnostic, health dashboard, health check, company health, functional health, team health, startup health, health scorecard, health assessment, risk dashboard\n\n## Quick Start\n\n```bash\npython scripts\u002Fhealth_scorer.py        # Guided CLI — enter metrics, get scored dashboard\npython scripts\u002Fhealth_scorer.py --json # Output raw JSON for integration\n```\n\nOr describe your metrics:\n```\n\u002Fhealth [paste your key metrics or answer prompts]\n\u002Fhealth:dimension [financial|revenue|product|engineering|people|ops|security|market]\n```\n\n## The 8 Dimensions\n\n### 1. ? Financial Health (CFO)\n**What it measures:** Can we fund operations and invest in growth?\n\nKey metrics:\n- **Runway** — months at current burn (Green: >12, Yellow: 6-12, Red: \u003C6)\n- **Burn multiple** — net burn \u002F net new ARR (Green: \u003C1.5x, Yellow: 1.5-2.5x, Red: >2.5x)\n- **Gross margin** — SaaS target: >65% (Green: >70%, Yellow: 55-70%, Red: \u003C55%)\n- **MoM growth rate** — contextual by stage (see benchmarks)\n- **Revenue concentration** — top customer % of ARR (Green: \u003C15%, Yellow: 15-25%, Red: >25%)\n\n### 2. ? Revenue Health (CRO)\n**What it measures:** Are customers staying, growing, and recommending us?\n\nKey metrics:\n- **NRR (Net Revenue Retention)** — Green: >110%, Yellow: 100-110%, Red: \u003C100%\n- **Logo churn rate (annualized)** — Green: \u003C5%, Yellow: 5-10%, Red: >10%\n- **Pipeline coverage (next quarter)** — Green: >3x, Yellow: 2-3x, Red: \u003C2x\n- **CAC payback period** — Green: \u003C12 months, Yellow: 12-18, Red: >18 months\n- **Average ACV trend** — directional: growing, flat, declining\n\n### 3. ? Product Health (CPO)\n**What it measures:** Do customers love and use the product?\n\nKey metrics:\n- **NPS** — Green: >40, Yellow: 20-40, Red: \u003C20\n- **DAU\u002FMAU ratio** — engagement proxy (Green: >40%, Yellow: 20-40%, Red: \u003C20%)\n- **Core feature adoption** — % of users using primary value feature (Green: >60%)\n- **Time-to-value** — days from signup to first core action (lower is better)\n- **Customer satisfaction (CSAT)** — Green: >4.2\u002F5, Yellow: 3.5-4.2, Red: \u003C3.5\n\n### 4. ⚙️ Engineering Health (CTO)\n**What it measures:** Can we ship reliably and sustain velocity?\n\nKey metrics:\n- **Deployment frequency** — Green: daily, Yellow: weekly, Red: monthly or less\n- **Change failure rate** — % of deployments causing incidents (Green: \u003C5%, Red: >15%)\n- **Mean time to recovery (MTTR)** — Green: \u003C1 hour, Yellow: 1-4 hours, Red: >4 hours\n- **Tech debt ratio** — % of sprint capacity on debt (Green: \u003C20%, Yellow: 20-35%, Red: >35%)\n- **Incident frequency** — P0\u002FP1 per month (Green: \u003C2, Yellow: 2-5, Red: >5)\n\n### 5. ? People Health (CHRO)\n**What it measures:** Is the team stable, engaged, and growing?\n\nKey metrics:\n- **Regrettable attrition (annualized)** — Green: \u003C10%, Yellow: 10-20%, Red: >20%\n- **Engagement score** — (eNPS or similar; Green: >30, Yellow: 0-30, Red: \u003C0)\n- **Time-to-fill (avg days)** — Green: \u003C45, Yellow: 45-90, Red: >90\n- **Manager-to-IC ratio** — Green: 1:5–1:8, Yellow: 1:3–1:5 or 1:8–1:12, Red: outside\n- **Internal promotion rate** — at least 25-30% of senior roles filled internally\n\n### 6. ? Operational Health (COO)\n**What it measures:** Are we executing our strategy with discipline?\n\nKey metrics:\n- **OKR completion rate** — % of key results hitting target (Green: >70%, Yellow: 50-70%, Red: \u003C50%)\n- **Decision cycle time** — days from decision needed to decision made (Green: \u003C48h, Yellow: 48h-1w)\n- **Meeting effectiveness** — % of meetings with clear outcome (qualitative)\n- **Process maturity** — level 1-5 scale (see COO advisor)\n- **Cross-functional initiative completion** — % on time, on scope\n\n### 7. ? Security Health (CISO)\n**What it measures:** Are we protecting customers and maintaining compliance?\n\nKey metrics:\n- **Security incidents (last 90 days)** — Green: 0, Yellow: 1-2 minor, Red: 1+ major\n- **Compliance status** — certifications current\u002Fin-progress vs. overdue\n- **Vulnerability remediation SLA** — % of critical CVEs patched within SLA (Green: 100%)\n- **Security training completion** — % of team current (Green: >95%)\n- **Pen test recency** — Green: \u003C12 months, Yellow: 12-24, Red: >24 months\n\n### 8. ? Market Health (CMO)\n**What it measures:** Are we winning in the market and growing efficiently?\n\nKey metrics:\n- **CAC trend** — improving, flat, or worsening QoQ\n- **Organic vs paid lead mix** — more organic = healthier (less fragile)\n- **Win rate** — % of qualified opportunities closed-won (Green: >25%, Yellow: 15-25%, Red: \u003C15%)\n- **Competitive win rate** — against primary competitors specifically\n- **Brand NPS** — awareness + preference scores in ICP\n\n---\n\n## Scoring & Traffic Lights\n\nEach dimension is scored 1-10 with traffic light:\n- ? **Green (7-10):** Healthy — maintain and optimize\n- ? **Yellow (4-6):** Watch — trend matters; improving or declining?\n- ? **Red (1-3):** Action required — address within 30 days\n\n**Overall Health Score:**\nWeighted average by company stage (see `references\u002Fhealth-benchmarks.md` for weights).\n\n---\n\n## Dimension Interactions (Why One Problem Creates Another)\n\n| If this dimension is red... | Watch these dimensions next |\n|-----------------------------|----------------------------|\n| Financial Health | People (freeze hiring) → Engineering (freeze infra) → Product (cut scope) |\n| Revenue Health | Financial (cash gap) → People (attrition risk) → Market (lose positioning) |\n| People Health | Engineering (velocity drops) → Product (quality drops) → Revenue (churn rises) |\n| Engineering Health | Product (features slip) → Revenue (deals stall on product) |\n| Product Health | Revenue (NRR drops, churn rises) → Market (CAC rises; referrals dry up) |\n| Operational Health | All dimensions degrade over time (execution failure cascades everywhere) |\n\n---\n\n## Dashboard Output Format\n\n```\nORG HEALTH DIAGNOSTIC — [Company] — [Date]\nStage: [Seed\u002FA\u002FB\u002FC]   Overall: [Score]\u002F10   Trend: [↑ Improving \u002F → Stable \u002F ↓ Declining]\n\nDIMENSION SCORES\n━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━\n? Financial    ? 8.2  Runway 14mo, burn 1.6x — strong\n? Revenue      ? 5.8  NRR 104%, pipeline thin (1.8x coverage)\n? Product      ? 7.4  NPS 42, DAU\u002FMAU 38%\n⚙️  Engineering  ? 5.2  Debt at 30%, MTTR 3.2h\n? People       ? 3.8  Attrition 24%, eng morale low\n? Operations   ? 6.0  OKR 65% completion\n? Security     ? 7.8  SOC 2 Type II complete, 0 incidents\n? Market       ? 5.5  CAC rising, win rate dropped to 22%\n━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━\n\nTOP PRIORITIES\n? [1] People: attrition at 24% — engineering velocity will drop in 60 days\n   Action: CHRO + CEO to run retention audit; target top 5 at-risk this week\n? [2] Revenue: pipeline coverage at 1.8x — Q+1 miss risk is high\n   Action: CRO to add 3 qualified opps within 30 days or shift forecast down\n? [3] Engineering: tech debt at 30% of sprint — shipping will slow by Q3\n   Action: CTO to propose debt sprint plan; COO to protect capacity\n\nWATCH\n→ People → Engineering cascade risk if attrition continues (see dimension interactions)\n```\n\n---\n\n## Graceful Degradation\n\nYou don't need all metrics to run a diagnostic. The tool handles partial data:\n- Missing metric → excluded from score, flagged as \"[data needed]\"\n- Score still valid for available dimensions\n- Report flags which gaps to fill for next cycle\n\n## References\n- `references\u002Fhealth-benchmarks.md` — benchmarks by stage (Seed, A, B, C)\n- `scripts\u002Fhealth_scorer.py` — CLI scoring tool with traffic light output\n",{"name":5,"license":15,"metadata":40,"description":7},{"author":41,"domain":42,"updated":43,"version":44,"category":45,"frameworks":46,"python-tools":47},"Alireza Rezvani","organizational-health",1772668800000,"1.0.0","c-level","health-benchmarks","health_scorer.py","main","c0a12fc98d85642fa8893e31fc5cf5dfad879de6","c-level-advisor\u002Forg-health-diagnostic",0,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111","https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i","2026-03-13 21:49:18",{"source":8,"skillName":5,"commands":56,"prompt":66,"zipAvailable":67},[57,60,63],{"tool":58,"command":59},"npx","npx skills add zhangzhang-111-i\u002Fclaude-skills111 --skill org-health-diagnostic",{"tool":61,"command":62},"bunx","bunx skills add zhangzhang-111-i\u002Fclaude-skills111 --skill org-health-diagnostic",{"tool":64,"command":65},"pnpm","pnpm dlx skills add zhangzhang-111-i\u002Fclaude-skills111 --skill org-health-diagnostic","安装技能，技能地址：https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Forg-health-diagnostic\u002FSKILL.md",true,[69,75,79],{"path":70,"resourceType":71,"resourceTypeDesc":72,"sizeBytes":73,"sourceHtmlUrl":74},"index.json","REFERENCE","参考文档",604,"https:\u002F\u002Fgithub.com\u002FDCx7C5\u002Fai-marketplace\u002Fblob\u002Fmain\u002Fskills\u002Flinux-fs-ntfs-mft-forensic\u002Findex.json",{"path":76,"resourceType":71,"resourceTypeDesc":72,"sizeBytes":77,"sourceHtmlUrl":78},"references\u002Fhealth-benchmarks.md",9094,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Forg-health-diagnostic\u002Freferences\u002Fhealth-benchmarks.md",{"path":80,"resourceType":81,"resourceTypeDesc":82,"sizeBytes":83,"sourceHtmlUrl":84},"scripts\u002Fhealth_scorer.py","SCRIPT","脚本",21377,"https:\u002F\u002Fgithub.com\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fc-level-advisor\u002Forg-health-diagnostic\u002Fscripts\u002Fhealth_scorer.py",[86,110,136,167,187,210],{"skillNo":87,"name":88,"nameZh":6,"description":89,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":90,"categories":91,"keywords":92,"publishedAt":35},"01M6DSNYM8PZKEXGYMRX53PVPH","risk-management-specialist","Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. 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\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Frisk-management-specialist\u002FSKILL.md",[],[22,93,94,95,96,97,98,99,100,101,102,25,26,103,104,105,106,107,108,109],"risk management specialist","management","risk management","risk analysis","risk evaluation","product","Evaluation","Production","lifecycle","analysis","risk matrix","Market","device","control","iso","medical","iso 14971",{"skillNo":111,"name":112,"nameZh":6,"description":113,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":114,"categories":115,"keywords":116,"publishedAt":35},"01M6DSNSRBGVZWS23TK0ZQ52QC","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\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md",[],[117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,108,135],"regulatory affairs head","regulatory","head","documentation","documents","packages","planning","devices","plan","access","write","strategy","evidence","standards","manage","intelligence","across","strategies","clinical",{"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":152,"publishedAt":35},"01M6DSNN7GNR2HZE66S4D31EP8","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\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qms-iso13485\u002FSKILL.md",[142,147],{"categoryNo":143,"categoryName":144,"taxonomyType":145,"taxonomyTypeDesc":146},"01JBSEEDCAT000000000000015","视觉设计","SCENARIO","使用场景",{"categoryNo":148,"categoryName":149,"taxonomyType":150,"taxonomyTypeDesc":151},"01JBSEEDCAT000000000000032","设计师","PROFESSION","适用职业",[153,154,155,156,157,158,120,159,160,161,162,163,26,118,164,165,166,106,107,108],"quality manager qms iso13485","quality","design","review","support","workflows","audit","actions","compliance","system","process","up","maintenance","document",{"skillNo":168,"name":169,"nameZh":6,"description":170,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":171,"categories":172,"keywords":176,"publishedAt":35},"01M6DSNE5PQM106PM4EDGPBWGZ","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\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qmr\u002FSKILL.md",[173],{"categoryNo":174,"categoryName":175,"taxonomyType":150,"taxonomyTypeDesc":151},"01JBSEEDCAT000000000000037","律师与法务",[177,154,156,178,179,180,181,161,182,162,94,183,118,184,185,186,107],"quality manager qmr","policy","performance","governance","monitoring","regulatory compliance","oversight","cost","culture","leadership",{"skillNo":188,"name":189,"nameZh":6,"description":190,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":191,"categories":192,"keywords":197,"publishedAt":35},"01M6DSN7MYXB6X42TB1GH2TNSB","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\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-documentation-manager\u002FSKILL.md",[193,196],{"categoryNo":194,"categoryName":195,"taxonomyType":145,"taxonomyTypeDesc":146},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":174,"categoryName":175,"taxonomyType":150,"taxonomyTypeDesc":151},[120,198,154,156,199,200,159,101,201,162,202,203,26,204,205,206,108,207,208,209],"quality documentation manager","workflow","change","document lifecycle","change management","list","master","system management","documentation review","cfr","21 cfr part 11","change control",{"skillNo":211,"name":212,"nameZh":6,"description":213,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":214,"categories":215,"keywords":216,"publishedAt":35},"01M6DSN3R749H3R20K15QE8X8W","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\u002Fzhangzhang-111-i\u002Fclaude-skills111\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fqms-audit-expert\u002FSKILL.md",[],[159,217,218,123,219,220,221,222,94,26,223,105,107,108],"qms audit expert","expert","verification","execution","classification","schedule","checklist"]