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。
alirezarezvani/claude-skills☆ 2.8万2026年8月30日 更新
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。
alirezarezvani/claude-skills☆ 2.8万2026年8月30日 更新
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。
alirezarezvani/claude-skills☆ 2.8万2026年8月30日 更新
/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。
alirezarezvani/claude-skills☆ 2.8万2026年8月30日 更新
Use when an ops leader (Director of CX, Head of Support, VP Ops, Head of BizOps, Head of IT ops, Head of Finance ops) is sizing ops capacity, building a headcount plan, modeling utilization risk, planning Q3 capacity or annual support capacity, or designing CS coverage — and needs Erlang-C queueing math, P90 demand sizing, shrinkage-adjusted FTE, manager-trigger thresholds, and a quarterly hiring sequence with ramp + attrition. Apply when sustained team utilization is above 80% or when the team is growing >50% in 12 months. Run before committing the headcount budget. This is NOT engineering capacity (see vpe-advisor for DORA + cycle time) and NOT strategic 3-year workforce planning (see chro-advisor).
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。
alirezarezvani/claude-skills☆ 2.8万2026年8月30日 更新
Chief AI Officer advisory for startups: model build-vs-buy decisions (API vs fine-tune vs in-house), AI risk classification under EU AI Act + US state patchwork, AI cost economics (API-to-self-hosted breakeven), and AI team org evolution. Use when deciding whether to call an API or fine-tune, classifying AI use cases for regulatory risk, calculating when self-hosting pays off, sequencing AI hires, or when user mentions CAIO, AI strategy, model selection, foundation model, fine-tuning, EU AI Act, NIST AI RMF, AI governance, model risk, or AI economics. Strategic only — does not duplicate engineering AI/ML skills.
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。
alirezarezvani/claude-skills☆ 2.8万2026年8月30日 更新
Runs batch and HPC workloads on GKE, utilizing job queues and parallel processing. Use when running GKE batch jobs, configuring GKE HPC, or setting up GKE job queues. Don't use for standard web application deployments (use gke-app-onboarding instead).
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/skills☆ 2.1万2026年10月14日 更新
Generates Cloud Monitoring Server-Driven UI (SDUI) Widget and XyChart Protocol Buffer textprotos on Google Cloud from resolved PromQL or ListTimeSeries queries. Use when: - Generating valid google.monitoring.dashboard.v1.Widget textprotos, containing PrometheusQuery or TimeSeriesFilter datasets, for use with the Cloud Monitoring Dashboards API, gcloud CLI, or declarative dashboard definitions. - Synthesizing Server-Driven UI (SDUI) widget titles, axis labels, and plot types for Prometheus or ListTimeSeries queries. Don't use for: - Metric discovery or PromQL query generation. For those tasks, use the cloud-monitoring-metric-selection or cloud-monitoring-promql-query skills.
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/skills☆ 2.1万2026年10月14日 更新
Export raw OpenTelemetry traces from an AI application to Confident AI's Observatory. TRIGGER when the user wants to send OpenTelemetry or OTLP traces/spans from an LLM app, agent, RAG pipeline, or chatbot to Confident AI; configure the Confident AI OTLP endpoint; set confident.span.* or confident.trace.* attributes; export AI-app traces without the deepeval Python package; wire an OTLPSpanExporter, OpenTelemetry Collector, or vendor-neutral OTel SDK to Confident AI; or pick the US vs EU OTLP endpoint. Language-agnostic: the mechanism is OTLP attribute keys plus an exporter endpoint. DO NOT TRIGGER for building DeepEval pytest eval suites, datasets, goldens, metrics, or deepeval test run (use the `deepeval` skill); for instrumenting with the DeepEval SDK's @observe decorator or framework integrations (use the `deepeval-tracing` skill); or for non-AI software such as web servers, CRUD backends, or infrastructure: the confident.* attributes describe AI components only.
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。
confident-ai/deepeval☆ 1.9万2026年10月13日 更新
Prometheus monitoring expert for PromQL, alerting rules, Grafana dashboards, and observability
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。
RightNow-AI/openfang☆ 1.8万2026年7月2日 更新
SSH job queue for multi-seed/multi-config ML experiments with OOM-aware retry, stale-screen cleanup, and wave-transition race prevention. Use when user says "batch experiments", "队列实验", "run grid", "multi-seed sweep", "auto-chain experiments", or when /run-experiment is insufficient for 10+ jobs that need orchestration.
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。
wanshuiyin/Auto-claude-code-research-in-sleep☆ 1.7万2026年10月7日 更新
Comprehensive guide for writing systems papers targeting OSDI, SOSP, ASPLOS, NSDI, and EuroSys. Provides paragraph-level structural blueprints, writing patterns, venue-specific checklists, reviewer guidelines, LaTeX templates, and conference deadlines. Use this skill for all systems conference paper writing.
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。
Orchestra-Research/AI-Research-SKILLs☆ 1.4万2026年10月11日 更新
Write publication-ready ML/AI papers for NeurIPS, ICML, ICLR, ACL, AAAI, COLM. Use when drafting papers from research repos, structuring arguments, verifying citations, or preparing camera-ready submissions. For systems venues (OSDI, NSDI, ASPLOS, SOSP), use systems-paper-writing instead.
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。
Orchestra-Research/AI-Research-SKILLs☆ 1.4万2026年10月11日 更新
Evaluates LLMs across 60+ academic benchmarks (MMLU, HumanEval, GSM8K, TruthfulQA, HellaSwag). Use when benchmarking model quality, comparing models, reporting academic results, or tracking training progress. Industry standard used by EleutherAI, HuggingFace, and major labs. Supports HuggingFace, vLLM, APIs.
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。
Orchestra-Research/AI-Research-SKILLs☆ 1.4万2026年10月11日 更新
Configures monitoring systems, implements structured logging pipelines, creates Prometheus/Grafana dashboards, defines alerting rules, and instruments distributed tracing. Implements Prometheus/Grafana stacks, conducts load testing, performs application profiling, and plans infrastructure capacity. Use when setting up application monitoring, adding observability to services, debugging production issues with logs/metrics/traces, running load tests with k6 or Artillery, profiling CPU/memory bottlenecks, or forecasting capacity needs.
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。
Jeffallan/claude-skills☆ 1.2万2026年10月4日 更新
Build and configure Laravel 10+ applications, including creating Eloquent models and relationships, implementing Sanctum authentication, configuring Horizon queues, designing RESTful APIs with API resources, and building reactive interfaces with Livewire. Use when creating Laravel models, setting up queue workers, implementing Sanctum auth flows, building Livewire components, optimising Eloquent queries, or writing Pest/PHPUnit tests for Laravel features.
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。
Jeffallan/claude-skills☆ 1.2万2026年10月4日 更新
当用户在重大选择上纠结(换工作/买房/搬城/合伙/结婚)、列了利弊表还是拿不定主意时调用。 核心理念: 无法决定就答否; 三个重大决定(住哪/和谁/做什么)值得花一两年; 两个均等选择选短期更痛苦的路。 不适用于: 日常琐碎选择(晚饭吃什么)、信息查询。 Triggers: 纠结/拿不定主意/要不要/该不该/利弊/decision/hesitate/should I
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。
kangarooking/cangjie-skill☆ 1.1万2026年10月2日 更新
EU AI Act per-system inventory — track each AI system's role (provider, deployer, importer, distributor, authorized representative, product manufacturer) and risk tier (prohibited, high-risk, limited, minimal, GPAI, GPAI+systemic). Role and tier are assessed per system, not per company. Use when the user says "ai inventory", "add an ai system", "what systems do we have", "classify this ai system", "eu ai act register", or "ai system registry".
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。
anthropics/claude-for-legal☆ 9,6632026年9月30日 更新
Builds reusable Convex components with isolated tables and app-facing APIs. Use for new components, reusable backend modules, integrations, or component boundary work.
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。
openclaw/clawhub☆ 9,5082026年10月13日 更新
Search reusable OpenSpace skills locally, and browse cloud packages step by step when a cloud skill may help. Reusing proven skills saves tokens, improves reliability, and extends your capabilities beyond built-in tools.
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。
HKUDS/OpenSpace☆ 7,7552026年8月13日 更新
Router for NVIDIA NuRec/NRE: USDZ rendering, NCore conversion, 3DGS, gRPC sensor sim, PhysicalAI HF datasets. Do NOT use for SimReady or infra setup.
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。
openai/plugins☆ 7,4352026年10月8日 更新
Use when classifying a slice closeout (auto-continue / human gate / park), routing a real decision to a human, or designing a human queue/dashboard surface. Treats humans as durable network participants with attention surfaces, queues, and decision records — escalation lands as a durable attention item, not a chat message. Approval is NOT required for every clean closeout; the default RSI conveyor continues unless an explicit human gate is reached.
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。
mvschwarz/openrig☆ 7,4182026年10月14日 更新
Use when ending a turn, finishing a slice, blocked on another agent's work, or escalating to a human — durable work handoff via queue items so the system keeps moving across compactions, missed messages, and interruptions. Covers the hot-potato terminal-turn-rule (active work ends by passing the ball, not by going idle), default-nudge semantics, and when `--no-nudge` is appropriate for intentional cold park or human gate.
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。
mvschwarz/openrig☆ 7,4182026年10月14日 更新
Create or update reusable iPolloWork templates through conversation for Design, Slides/native editable PPT, and HyperFrames Video. Use when planning, generating, repairing, validating, or saving a template package, manifest, reusable variables, cover, slide/PPT markers, video composition, or design-system token integration.
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。
Devin-AXIS/iPolloWork☆ 6,9422026年10月13日 更新