「claude-skills」の検索結果

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。

Adversarial thinking partner for founders and executives. Stress-tests plans, prepares for brutal board meetings, dissects decisions with no good options, and forces honest post-mortems. Use when you need someone to find the holes before the board does, make a decision you've been avoiding, or understand what actually went wrong.

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。

Explicitly save important knowledge to auto-memory with timestamp and context. Use when a discovery is too important to rely on auto-capture.

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。

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。

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。

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.

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 test coverage gaps. Use when user says "test coverage", "what's not tested", "coverage gaps", "missing tests", "coverage report", or "what needs testing".

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。

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 verification, or CAPA program 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。

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。

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。

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。

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。

Google Workspace administration via the gws CLI (github.com/googleworkspace/cli). Install, authenticate, and automate Gmail, Drive, Sheets, Calendar, Docs, Chat, and Tasks. Run security audits and use local recipe templates and persona bundles. Use for Google Workspace admin, gws CLI setup, Gmail automation, Drive management, or Calendar scheduling.

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:hard-call — Framework for decisions with no good options. Use when every option is painful and a structured 10/10/10 + regret-minimization pass is needed — e.g. choosing between a layoff and a down round, or killing a beloved product line.

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。

Pre-mortem plan analysis. Imagine the plan failed 12 months from now and work backwards to find the weaknesses. Surfaces assumptions, dependencies, and execution risks before committing resources. Use when before significant resource commitment, before presenting to a board or investors, when feedback has been one-sidedly positive, or when there is pressure to move fast and figure it out later.

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。

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。

Accessibility audit skill for scanning, fixing, and verifying WCAG 2.2 Level A and AA compliance across React, Next.js, Vue, Angular, Svelte, and plain HTML codebases. Use when auditing accessibility, fixing a11y violations, checking color contrast, generating compliance reports, or integrating accessibility checks into CI/CD pipelines.

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。

Use when managing the money for an internal R&D program or portfolio — building a multi-period program budget with the F&A (indirect) split, tracking burn rate and runway against value-inflection milestones, or routing R&D cost items to a capitalize-vs-expense determination. Every budget output surfaces its assumptions block; capitalize-vs-expense is decision-support only and routes to a named finance owner — it never books an entry or decides accounting treatment. Distinct from finance/financial-analysis (corporate DCF, close, valuation) and research/grants (funding discovery — this manages money already won).

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。

Turn a proven pattern or debugging solution into a standalone reusable skill with SKILL.md, reference docs, and examples. Use when the user runs /si:extract or asks to package a recurring solution from memory into a skill.

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, funding, scoping, or synthesizing enterprise research across workstreams — clinical study design, R&D program finance, market sizing/surveys, or product/user research. Triggers on "design this clinical study", "what sample size", "R&D budget", "burn rate", "capitalize or expense", "TAM SAM SOM", "market sizing", "survey design", "segment the market", "plan user interviews", "usability test", "synthesize research insights". Forks context to route to one of four Research-Operations sub-skills (clinical-research, research-finance, market-research, product-research) and returns a digest. Distinct from ra-qm-team (regulatory submission), finance (corporate close/valuation), research/grants (funding discovery), product-team (persona/journey/live experiments), and marketing-skill (campaign analytics).

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。

Set up Playwright in a project. Use when user says "set up playwright", "add e2e tests", "configure playwright", "testing setup", "init playwright", or "add test infrastructure".

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。