「lia」の検索結果

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。

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。

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。

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。

Manage local SEO for service-area businesses — appliance repair, HVAC, plumbing, cleaning, and any business that serves customers at their location. Use when the user wants to: audit Google Business Profile, generate neighborhood service area pages, check NAP consistency across directories, create LocalBusiness schema, or write review responses. Triggers: 'local SEO', 'Google Business Profile', 'GBP', 'service area page', 'NAP consistency', 'local citations', 'LocalBusiness schema', 'review responses', 'Google Maps ranking'. NOT for national SEO (use seo-audit). NOT for general schema (use schema-markup). NOT for AI answer-engine visibility (use aeo).

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。

Design production-grade multi-agent workflows with clear pattern choice (sequential, parallel, hierarchical), handoff contracts, failure handling, and cost/context controls. Use when architecting a multi-step agent pipeline, choosing between single-agent vs multi-agent approaches, or refactoring an LLM workflow that suffers from context bloat or unreliable handoffs.

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, running, or learning from chaos engineering experiments. Triggers on "chaos experiment", "fault injection", "gameday", "resilience test", "blast radius", "steady state", "abort criteria", "Chaos Toolkit", "Chaos Mesh", "Litmus", "Gremlin", "AWS FIS", or any deliberate failure-injection question. Ships experiment designer, blast-radius calculator, and postmortem generator (all stdlib Python), 4 references on chaos principles + experiment design + attack taxonomy + tooling landscape, and a /chaos-experiment slash command. Composes with feature-flags-architect (kill switches as abort triggers) and kubernetes-operator (common chaos targets).

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 a codebase and generate onboarding documentation for engineers, tech leads, and contractors. Fast fact-gathering and repeatable onboarding outputs. Use when onboarding a new engineer, writing architecture-overview docs for a new project, or producing tech-lead briefings for unfamiliar repos.

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。

Index of 37 advanced engineering agent skills for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. Use when browsing or choosing among the POWERFUL-tier engineering skills: agent design, RAG, MCP servers, CI/CD, database design, observability, security auditing, changelog/release automation, reliability (SLO/chaos/flags/operators), platform ops.

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 Stripe integrations: subscriptions with trials and proration, one-time payments, usage-based billing, checkout sessions, idempotent webhook handlers, customer portal, and invoicing. Covers Next.js, Express, and Django patterns. Use when integrating Stripe for the first time, debugging webhook reliability issues, migrating from a different payment provider, or adding usage-based billing to an existing subscription product.

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。

Microsoft 365 tenant administration for Global Administrators. Automate M365 tenant setup, Office 365 admin tasks, Azure AD user management, Exchange Online configuration, Teams administration, and security policies. Generate PowerShell scripts for bulk operations, Conditional Access policies, license management, and compliance reporting. Use for M365 tenant manager, Office 365 admin, Azure AD users, Global Administrator, tenant configuration, or Microsoft 365 automation.

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。

Audit and manage dependencies across multi-language projects. Identifies vulnerabilities, license conflicts, transitive dependency risks, and safe-upgrade paths. Use when auditing third-party packages before release, investigating a CVE, planning a major version bump, or running a license-compliance review. Examples: 'audit our npm dependencies', 'do we have GPL contamination', 'plan the upgrade to React 19'.

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。

International market expansion strategy. Market selection, entry modes, localization, regulatory compliance, and go-to-market by region. Use when expanding to new countries, evaluating international markets, planning localization, or building regional teams.

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。

/cs:ciso-review <plan> — Risk-paranoid interrogation of any plan that touches data, compliance, or production access. Use when launching features that handle customer data, before a SOC 2 / ISO audit, or after any incident or near-miss.

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。

/cs:ai-act-readiness <system> — EU AI Act 6-question forcing interrogation. Use during AI-system intake, before EU deployment, or during annual compliance refresh as Article 113 obligations phase in (2025-02-02 / 2025-08-02 / 2026-08-02 / 2027-08-02).

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 a Head of People Ops, BizOps lead, or Internal Communications owner needs to draft and sequence an internal-only change-management communication — a re-org announcement, a tool rollout, a policy change, a leadership transition, a layoff, an acquisition close, or an internal product launch — and the audience is employees (not customers). Pairs Prosci ADKAR and Kotter's 8-step change model with deterministic stdlib-only Python tools to produce a sequenced touchpoint calendar, a Kotter-compliant primary announcement, an audience-segmented FAQ, and manager cascade talking points; industry-tuned via --profile {tech-startup, scaleup, enterprise, public-company, non-profit}. Triggers on "all-hands announcement", "change comms", "rollout comms", "re-org announcement", "manager talking points", "layoff comms".

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 reviewing, scoring, or auditing third-party SaaS / vendor relationships — running a vendor scorecard with industry tuning, tracking SLA compliance with credit-claim flags, classifying third-party risk across 4 risk vectors, preparing a tier-1 vendor review, or auditing the SaaS portfolio. Forks context so large vendor catalogs (50-500 line items) and SLA logs don't pollute the parent thread. Triggers on "vendor SLA", "vendor scorecard", "third-party risk", "TPRM", "vendor review", "supplier performance", "vendor health check", "renewal 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。

Use when a BizOps lead, COO, or process-improvement owner needs to document an end-to-end business process (procurement, employee onboarding, incident handoff, customer-onboarding, claims adjudication) in BPMN-style notation, measure cycle times by stage, surface where work spends most of its time waiting vs. being worked, and quantify the gap between processing time and total elapsed time. Pairs Lean / Six Sigma / Theory-of-Constraints canon with deterministic stdlib-only Python tools to produce a process map, a ranked bottleneck list (with severity + root-cause hypothesis), and a cycle-time analysis (P50, P90, value-add ratio, Little's-Law throughput). Distinct from sales-pipeline, system-reliability (SLO), and strategic-OKR work — this is tactical process documentation for internal operations.

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。

Validate skill files for structural compliance and behavioral correctness. Four modes: static linter, spec, category rubric, audit.

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。

Brownfield audit — do existing artifacts actually work? Numbered migration plan. Unlike /project-stage-detect, checks compliance not existence.

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。