claude

ra-qm-skills

14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, CAPA management, risk management, clinical evaluation, SOC 2 compliance.

0 on GitHubby Alireza Rezvaniv2.9.0MITupdated 2 months agocompliance
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Plugin ra-qm-skills from marketplace claude-code-skills in GongYuanCaiJi/dsh-claude-skills. Commands read from the repo's manifest — 1 month ago.

What it installs

Skills (17)

  • agent-decision-receipts

    Mint a tamper-evident, post-quantum-signed receipt for a consequential agent action (deploy, delete, pay, grant-access, model decision) so it can be verified later from the certificate alone. Use when an autonomous agent takes a side-effecting action that may need to be proven later, or when satisfy

  • capa-officer

    CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verificati

  • eu-ai-act-specialist

    EU AI Act (Regulation (EU) 2024/1689) operational compliance for compliance teams. Three Article-level decisions: (1) What's the risk tier of this AI system — prohibited (Art. 5), high-risk (Art. 6 + Annex III), limited-risk (Art. 50), or minimal-risk? (2) For high-risk systems, what's the Article 4

  • fda-consultant-specialist

    FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k

  • gdpr-dsgvo-expert

    GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests with Art. 12(3) one-month deadlines. Use when running GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, or data subj

  • information-security-manager-iso27001

    ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use when designing an ISMS, running security risk assessments, implementing controls, pursuing ISO 27001 certification, preparing security audits, responding to security incidents, or verifying complianc

  • isms-audit-expert

    Information Security Management System (ISMS) audit expert for ISO 27001 compliance verification, security control assessment, and certification support. Use when the user mentions ISO 27001, ISMS audit, Annex A controls, Statement of Applicability (SOA), gap analysis, nonconformity management, inte

  • iso42001-specialist

    ISO/IEC 42001:2023 AI Management System (AIMS) specialist for compliance teams running internal audits. Three decisions: (1) Where are the gaps against Clauses 4-10 and what do we close first? (2) What goes in the AI risk register and which Annex A controls treat each risk? (3) What's the 12-month i

  • mdr-745-specialist

    EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, Art. 86 PSUR schedules, and EUDAMED integration. Use

  • qms-audit-expert

    ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.

  • 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 when working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance,

  • 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. Use when leading management reviews, setting quality

  • 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, managi

  • ra-qm-skills

    Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't ob

  • 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 u

  • 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 identifi

  • soc2-compliance

    Use 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.

View source on GitHub

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33 C-level advisory skills + c-level-agents plugin layer: virtual board of directors (CEO, CTO, COO, CPO, CMO, CFO, CRO, CISO, CHRO) plus General Counsel, CDO, CAIO, CCO, and VP of Engineering (DORA delivery throughput analyzer, engineering hiring funnel calculator with conversion + pipeline gap, eng team structure designer with squad/tribe + manager-trigger), executive mentor, founder coach, orchestration (Chief of Staff, board meetings, decision logger), strategic capabilities (board deck builder, scenario war room, competitive intel, M&A playbook), culture frameworks, and 13 cs-* persona agents + 21 /cs:* slash commands (founder-mode router, office-hours intake, multi-role boardroom, strategic sprint pipeline, cross-model consensus, cooldown freeze).

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32 engineering skills: architecture, frontend, backend, fullstack, QA, DevOps, security, AI/ML, data engineering, Playwright (9 sub-skills), self-improving agent, Stripe integration, TDD guide, tech stack evaluator, Google Workspace CLI, a11y audit (WCAG 2.2), Azure cloud architect, GCP cloud architect, security pen testing, Snowflake development, adversarial-reviewer, ai-security, cloud-security, incident-response, red-team, threat-detection. v2.8.1 audits senior-fullstack / senior-frontend / senior-backend against karpathy-coder + Matt Pocock — each ships a 7-question forcing-question library, 4 customization profiles (JSON), deterministic decision engine, composition map into POWERFUL specialists, plus cs-fullstack-engineer / cs-frontend-engineer / cs-backend-engineer orchestrator agents (context: fork) + /cs:fullstack-review, /cs:frontend-review, /cs:backend-review, /cs:engineer-grill slash commands.

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Per-deal-and-packaging Commercial domain. v2.8.0 ships 8 skills: orchestrator + pricing-strategist (model picker + Van Westendorp WTP + packaging) + deal-desk (deal scorer + discount approval routing + redline) + partnerships-architect (5-tier classifier + joint GTM + revshare modeler) + channel-economics (cost-to-serve + ROI + mix optimizer) + commercial-policy (data-backed discount matrix + exception flow + linter) + rfp-responder (Shipley structured RFP/RFI/RFQ + win-theme + winrate predictor, context: fork) + commercial-forecaster (4Q-weighted bookings + cohort NRR/GRR + funnel-confidence with mandatory assumption disclosure). Hard rules: pricing outputs model+range (never a single number), deal outputs route to named human approver (never auto-approve), forecast outputs surface conversion assumption, RFP never invents claims for GAP requirements. 21 stdlib Python tools, 28+ reference docs. Distinct from business-growth (sales execution), c-level-advisor/cro-advisor (strategic), finance (close+report).

8 skills · 9 commands · 1 agent

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