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.

29,725 on GitHubby Alireza Rezvaniv2.14.12MITupdated yesterdaycompliance
/

Plugin ra-qm-skills from marketplace claude-code-skills in alirezarezvani/claude-skills. Commands read from the repo's manifest — today.

What it installs

Skills (21)

  • access-lifecycle

    Use when preparing or running a user access review, checking that leavers lost their access, finding orphaned or ownerless service accounts, answering an auditor's access-control request for SOC 2, ISO 27001, PCI DSS, HIPAA or NIST 800-53, or checking whether a finished review campaign will hold up.

  • agent-decision-receipts

    Use when an autonomous agent takes a side-effecting action (deploy, delete, pay, grant access) that may need proving later, or for EU AI Act Art. 12 record-keeping. Builds a tamper-evident signed receipt with build_action_manifest.py and verifies it.

  • capa-officer

    Use for CAPA work in a medical device QMS: root cause analysis (5-Why, fishbone), corrective action plans, effectiveness checks or CAPA metrics. Tracks CAPAs with capa_tracker.py and analyzes causes with root_cause_analyzer.py.

  • cmmc-readiness

    Use when a defense contractor or subcontractor is preparing for a CMMC 2.0 Level 2 self-assessment or C3PAO assessment, calculating or checking an SPRS score against NIST SP 800-171 Rev 2, deciding what can go on a POA&M, tracking POA&M closeout before Conditional status expires, or scoping assets,

  • cra-readiness

    Use when a company that sells software, connected devices or firmware in the EU asks whether the Cyber Resilience Act (CRA, Regulation 2024/2847) applies, has to report an actively exploited vulnerability or security incident under Article 14 (24h/72h deadlines, ENISA Single Reporting Platform), mus

  • eu-ai-act-specialist

    Use for EU AI Act (Regulation 2024/1689) compliance work: classifying an AI system's risk tier, planning the Art. 43 conformity route and Annex IV file, or listing obligations by role. Runs ai_system_risk_classifier.py, conformity_assessment_planner.py and ai_act_obligation_tracker.py, citing Articl

  • fda-consultant-specialist

    Use for FDA medical device questions: 510(k) vs De Novo vs PMA, predicates and substantial equivalence, QMSR (21 CFR 820), HIPAA or device cybersecurity. Runs fda_submission_tracker.py, qsr_compliance_checker.py and hipaa_risk_assessment.py.

  • gdpr-dsgvo-expert

    Use for GDPR or DSGVO work: scanning a codebase for privacy risks, writing a DPIA or tracking data subject requests against the Art. 12(3) deadline. Runs gdpr_compliance_checker.py, dpia_generator.py and data_subject_rights_tracker.py; final calls go to the DPO.

  • information-security-manager-iso27001

    Use when designing or running an ISO 27001 ISMS in HealthTech or MedTech: risk assessment, control implementation, certification or security incidents. Assesses risk with risk_assessment.py and checks controls with compliance_checker.py.

  • isms-audit-expert

    Use for ISO 27001 audit work: internal or surveillance audits, Annex A control evidence, Statement of Applicability, nonconformities, Stage 1 and 2 prep. Plans risk-based audits with isms_audit_scheduler.py.

  • iso42001-specialist

    Use for ISO/IEC 42001 AI management system work: gap analysis against Clauses 4-10, the AI risk register and Annex A controls, or the internal audit plan. Runs aims_gap_analyzer.py, ai_risk_register_builder.py and aims_audit_scheduler.py.

  • mdr-745-specialist

    Use for EU MDR 2017/745 work: device classification under Annex VIII, technical file gaps (Annex II/III), clinical evaluation, PMS and PSUR cadence, notified body prep. Checks the file with mdr_gap_analyzer.py.

  • medical-device-software

    Use for any question about the software inside a medical device, SaMD or regulated health app - which IEC 62304 safety class (A/B/C) it is and how much process and documentation that class needs, what to record about open-source or third-party libraries (SOUP, SBOM), trace matrix and release testing

  • qms-audit-expert

    Use for ISO 13485 internal audits: planning the program, running an audit, classifying findings or preparing for an external audit. Optimizes the schedule with audit_schedule_optimizer.py.

  • quality-documentation-manager

    Use for QMS document control: numbering, versioning, change control or 21 CFR Part 11 e-signatures. Validates documents with document_validator.py and tracks versions with document_version_control.py.

  • quality-manager-qmr

    Use for QMR duties under ISO 13485 5.5.2: management review, quality policy and objectives, quality KPIs and cost of quality. Tracks reviews with management_review_tracker.py and monitors effectiveness with quality_effectiveness_monitor.py.

  • quality-manager-qms-iso13485

    Build or maintain an ISO 13485 medical device QMS: design, documentation, CAPA, audit prep. Use whenever the user faces a 13485 certification audit or needs quality procedures.

  • ra-qm-skills

    Router for regulatory and quality skills: ISO 13485, MDR, FDA, ISO 14971, CAPA, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2. Use whenever a compliance request fits no single one.

  • regulatory-affairs-head

    Use for medical device market access strategy: FDA 510(k), De Novo or PMA packages, CE marking under MDR, pre-sub meetings, agency deficiency responses or multi-market plans. Analyzes pathways with regulatory_pathway_analyzer.py and tracks submissions with regulatory_tracker.py.

  • risk-management-specialist

    Use for ISO 14971 medical device risk management: hazard analysis, FMEA, fault trees, risk controls, benefit-risk or residual risk. Runs fmea_analyzer.py and risk_matrix_calculator.py.

  • 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 alirezarezvani.medium.com

More from alirezarezvani/claude-skills

All 113 plugins →

engineering-advanced-skills

claude

45 advanced engineering skills: agent designer, agent workflow designer, RAG architect, database designer + schema designer + SQL assistant, migration architect, observability designer, dependency auditor, changelog generator, API design reviewer, API test suite builder, CI/CD pipeline builder, MCP server builder, skill security auditor, skill tester, performance profiler, focused-fix, browser-automation, full-page-screenshot, git-worktree-manager, monorepo-navigator, codebase-onboarding, interview-system-designer, runbook-generator, spec-driven-workflow, secrets-vault-manager, env-secrets-manager, pr-review-expert, self-eval, tc-tracker, feature-flags-architect, kubernetes-operator, chaos-engineering, ship-gate, slo-architect (error-budget + multi-window burn-rate alerts per Google SRE Workbook), tech-debt-tracker, agent-regression-evals, coding-agent-rollout, commit-craft, agent-run-forensics and i18n-localization. Agent skill and plugin for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw.

48 skills · hooks

29,725

marketing-skills

claude

47 marketing skills across 8 pods: Content, SEO & AEO, CRO, Channels, Growth, Intelligence, Sales enablement, and X/Twitter growth. 62 Python tools, 89 reference docs.

47 skills · hooks

29,725

engineering-skills

claude

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.

35 skills · hooks

29,725

c-level-agents

claude

Founder-mode executive team plugin: 13 cs-* C-suite agents (CFO, CMO, CRO, CPO, COO, CHRO, CISO, Chief of Staff, General Counsel, Chief Data Officer, Chief AI Officer, Chief Customer Officer, VP of Engineering) with distinct cognitive voices, plus 21 /c-level-agents:* slash commands — forcing-question office hours (CFO/CMO/CPO/CRO/CTO/CISO/GC/CDO/CAIO/CCO/VPE reviews), strategic sprint pipeline (brief → boardroom → decide → execute → post-mortem), and meta routing (/c-level-agents:founder-mode auto-router, /cs-onboard, /c-level-agents:cross-eval multi-model consensus, /c-level-agents:freeze cooldown lock). Wraps the 33 c-level skills with cognitive gearing, persona voice, and artifact-driven handoffs. The business-domain answer to YC Garry Tan's gstack.

22 skills · 13 agents

29,725

c-level-skills

claude

33 C-level advisory skills (install the separate companion c-level-agents plugin for the persona 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. The 13 cs-* persona agents + 21 /c-level-agents:* slash commands (founder-mode router, office-hours intake, multi-role boardroom, strategic sprint pipeline, cross-model consensus, cooldown freeze) ship in the companion c-level-agents plugin.

34 skills · hooks

29,725

agent-launcher-skills

claude

Build, launch, grade, and schedule Claude Managed Agents (CMA) in your own Anthropic account — a plugin re-implementation of Anthropic's launch-your-agent reference skill (Apache-2.0; independent, not a fork). Every session starts with a goal (./my-agent/goal.json, opt-in SessionStart hook, driven by /cs-goal); loop_compiler.py compiles it into a bounded grade->iterate loop (max_iterations 1..20), a recurring cron scheduled-deployment loop, or a single-pass interview->stage->launch workflow. 6 skills: orchestrator (context: fork goal router) + interview + stage-launch + grade-iterate + run-without-you + wrap-up. 18 stdlib-only deterministic scaffolders (no network/API calls; live launches emitted as BYOK curl that never prints the key), 4 agents, 8 commands, hooks, 5 references, 4 assets. Validators enforce CMA limits. Distinct from engineering/agent-harness (generic domain loop) and write-a-skill (authors Claude Code skills, not CMAs).

6 skills · 8 commands · 4 agents · hooks

29,725

Similar plugins

pr-review-toolkit

claude

Comprehensive PR review agents specializing in comments, tests, error handling, type design, code quality, and code simplification

1 command · 6 agents

anthropics/claude-code 155,476

agentic-qe-fleet

claude

Agentic QE (external: maintained in proffesor-for-testing/agentic-qe, pinned to v3.15.17): a quality-engineering fleet with 11 QE agents, 9 skills, 9 commands, the agentic-qe MCP server pinned to the plugin version, and the aqe-mod guard that refuses destructive operations on AQE learning data

9 skills · 9 commands · 11 agents · 1 MCP server

ruvnet/ruflo 81,589

AAS Privacy & Compliance Engineering

codex

Install the "AAS Privacy & Compliance Engineering" workflow plugin from Agentic Awesome Skills.

6 skills

sickn33/agentic-awesome-skills 49,620

carta-investors

claude

Carta Investors plugin — skills for querying investor data, performance benchmarks, regulatory reporting, AGM deck generation, brand extraction, and more via the Carta MCP Server.

29 skills · hooks

anthropics/claude-plugins-official 47,076

security-scanning

claudecodex

SAST analysis, dependency vulnerability scanning, OWASP Top 10 compliance, container security scanning, and automated security hardening

5 skills · 3 commands · 2 agents

wshobson/agents 42,461

twilio-developer-kit

claudecodex

Twilio Skills provide procedural knowledge for AI coding agents — which APIs to use, in what order, and what to avoid. Covers SMS, Voice, WhatsApp, Verify, SendGrid, Compliance, and 30+ products.

57 skills · 1 MCP server

anthropics/knowledge-work-plugins 35,601

Maintain ra-qm-skills?

This page updates itself from your repo. Add the badge to your README, or get it Featured to pin it above the organic results with a followed link to your site.

claude & codex plugins113 plugins