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Graduate a proven pattern from auto-memory (MEMORY.md) to CLAUDE.md or .claude/rules/ for permanent enforcement. Use when the user runs /si:promote or asks to make a learned behavior permanent.

日本語の概要は準備中です。原文の説明を表示しています。

Production-grade Playwright testing toolkit. Use when the user mentions Playwright tests, end-to-end testing, browser automation, fixing flaky tests, test migration, CI/CD testing, or test suites. Generate tests, fix flaky failures, migrate from Cypress/Selenium, sync with TestRail, run on BrowserStack. 55 templates, 3 agents, smart reporting.

日本語の概要は準備中です。原文の説明を表示しています。

Memory health dashboard showing line counts, topic files, capacity, stale entries, and recommendations. Use when the user runs /si:memory-status or asks how full or healthy the agent memory is.

日本語の概要は準備中です。原文の説明を表示しています。

/em:stress-test — Business assumption stress testing. Use before betting on a plan whose core assumptions are unvalidated — e.g. stress-testing 'enterprise buyers will tolerate a 6-month pilot' or a hockey-stick revenue model.

日本語の概要は準備中です。原文の説明を表示しています。

Run tests on BrowserStack. Use when user mentions "browserstack", "cross-browser", "cloud testing", "browser matrix", "test on safari", "test on firefox", or "browser compatibility".

日本語の概要は準備中です。原文の説明を表示しています。

Review Playwright tests for quality. Use when user says "review tests", "check test quality", "audit tests", "improve tests", "test code review", or "playwright best practices check".

日本語の概要は準備中です。原文の説明を表示しています。

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 2017/745; 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.

日本語の概要は準備中です。原文の説明を表示しています。

Use when doing upstream market-research methodology — sizing a market as TAM/SAM/SOM computed BOTH top-down and bottoms-up (never a single unsourced number), planning a survey sample size with finite-population correction and per-segment minimums, or scoring candidate market segments against Kotler's measurable/substantial/accessible/differentiable/actionable criteria. Outputs always show the method and the assumptions. For market-research analysts and product-marketing at the sizing/survey/segmentation moment. Distinct from marketing-skill (campaign analytics, attribution, demand-gen) — this is the evidence-building methodology, not live-campaign optimization.

日本語の概要は準備中です。原文の説明を表示しています。

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.

日本語の概要は準備中です。原文の説明を表示しています。

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, or regulatory documentation review.

日本語の概要は準備中です。原文の説明を表示しています。

Generate Playwright tests. Use when user says "write tests", "generate tests", "add tests for", "test this component", "e2e test", "create test for", "test this page", or "test this feature".

日本語の概要は準備中です。原文の説明を表示しています。

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 43 conformity assessment route (Module A internal control vs Module H full QMS + notified body) and what goes in the Annex IV technical documentation? (3) Per organizational role (provider / deployer / importer / distributor / authorized representative), what are the active obligations and deadlines? Use during AI system intake review, when planning conformity assessment, or when scoping deployer obligations. Cites Articles + Annexes for every output. NOT executive AI strategy (see chief-ai-officer-advisor). NOT a legal substitute.

日本語の概要は準備中です。原文の説明を表示しています。

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 internal audit plan that satisfies Clause 9.2? Use when preparing for certification, scoping internal audit cycles, or onboarding AI systems into an existing ISMS (27001) / QMS (13485) program. NOT an executive AI strategy skill (see chief-ai-officer-advisor). NOT EU AI Act compliance (see compliance-team-eu-ai-act).

日本語の概要は準備中です。原文の説明を表示しています。

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, internal audit, surveillance audit, or security certification preparation. Helps review control implementation evidence, document audit findings, classify nonconformities, generate risk-based audit plans, map controls to Annex A requirements, prepare Stage 1 and Stage 2 audit documentation, and support corrective action workflows.

日本語の概要は準備中です。原文の説明を表示しています。

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 when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').

日本語の概要は準備中です。原文の説明を表示しています。

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 obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act').

日本語の概要は準備中です。原文の説明を表示しています。

Use when designing a prospective clinical study before submission — selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging), estimating sample size and power for two-arm designs (means / proportions / survival), or scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision. Every output is an ESTIMATE plus a named human owner (clinician / biostatistician / regulatory owner) — never clinical fact, never a finished protocol. Distinct from ra-qm-team, which handles the regulatory/QM submission (ISO 13485, EU MDR, FDA 510(k)/PMA/QSR), not the study design.

日本語の概要は準備中です。原文の説明を表示しています。

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 compliance. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.

日本語の概要は準備中です。原文の説明を表示しています。

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.

日本語の概要は準備中です。原文の説明を表示しています。

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 subject rights (DSAR) management (e.g., 'check this service for GDPR risks', 'track an access request deadline'). Final compliance determinations route to the DPO or legal counsel.

日本語の概要は準備中です。原文の説明を表示しています。

Analyze auto-memory for promotion candidates, stale entries, consolidation opportunities, and health metrics. Use when the user runs /si:memory-review or asks what has been learned and what should be promoted or pruned.

日本語の概要は準備中です。原文の説明を表示しています。

Use when planning and synthesizing product/user research as a method-and-repository discipline — selecting the right method for the goal (generative interviews vs usability test vs concept test vs validation), computing method-based saturation/sample size with an explicit confidence level, or synthesizing coded observations into insights while flagging single-source anecdotes. Never fabricates user insight; an insight requires recurrence across independent participants. Distinct from product-team/ux-researcher-designer (persona/journey artifacts), product-discovery (discovery-sprint planning), and experiment-designer (live A/B) — this is the research-ops method + insight-repository layer.

日本語の概要は準備中です。原文の説明を表示しています。

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 policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.

日本語の概要は準備中です。原文の説明を表示しています。

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), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

日本語の概要は準備中です。原文の説明を表示しています。