「iga」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.

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Systematic performance profiling for Node.js, Python, and Go applications. Identifies CPU, memory, and I/O bottlenecks, generates flamegraphs, analyzes bundle sizes, optimizes database queries, runs load tests with k6 and Artillery. Always measures before and after. Use when investigating a slow endpoint, planning a performance budget, or hunting a memory leak in production.

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Converts a markdown deck (slides separated by `---` HR boundaries or by `# ` H1 headings, with optional `<!-- notes: ... -->` presenter notes blocks) into a single-file HTML presentation with arrow-key / space / PgDn / PgUp / Home / End / P / Esc keyboard navigation, presenter mode (split view with current slide + speaker notes + clock + next-slide preview), URL-hash deep linking, and `@media print` page-per-slide for PDF export. Triggers when the markdown-html-orchestrator classifies an input as SLIDES, or when invoked directly via /cs:md-slides. Reuses md-document's markdown parser for slide-body rendering and reads design-system tokens via config_loader.py. Refuses if input has no clear slide boundaries, produces a 1-slide deck, or `--strict-notes` is on with < 50% notes coverage. Use after orchestrator routing.

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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'.

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/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).

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/cs:gdpr-audit-prep <scope> — GDPR audit 6-question Article-cited forcing interrogation. Use before annual internal GDPR review, post-breach internal audit, DPA investigation readiness, or acquisition due diligence.

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End-user control of cmux topology and routing (windows, workspaces, panes/surfaces, focus, moves, reorder, identify, trigger flash). Use when automation needs deterministic placement and navigation in a multi-pane cmux layout.

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Enter explore mode - a thinking partner for exploring ideas, investigating problems, and clarifying requirements. Use when the user wants to think through something before or during a change.

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Repository-grounded threat modeling that enumerates trust boundaries, assets, attacker capabilities, abuse paths, and mitigations, and writes a concise Markdown threat model. Trigger only when the user explicitly asks to threat model a codebase or path, enumerate threats/abuse paths, or perform AppSec threat modeling. Do not trigger for general architecture summaries, code review, or non-security design 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。

Bootstrap, develop, and design modern WinUI 3 desktop applications with C# and the Windows App SDK using official Microsoft guidance, WinUI Gallery patterns, Windows App SDK samples, and CommunityToolkit components. Use when creating a brand new app, preparing a machine for WinUI, reviewing, refactoring, planning, troubleshooting, environment-checking, or setting up WinUI 3 XAML, controls, navigation, windowing, theming, accessibility, responsiveness, performance, deployment, or related Windows app design and development work.

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Use when the task requires automating a real browser from the terminal (navigation, form filling, snapshots, screenshots, data extraction, UI-flow debugging) via `playwright-cli` or the bundled wrapper script.

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Project conventions for writing, editing, restructuring, or reviewing the beads user documentation — the Mintlify site under docs/. Use this whenever you touch anything in docs/ (pages, concept docs, reference, integration guides, recovery runbooks, diagrams, docs.json navigation) or write/edit prose about beads, even when the request is just "fix the docs", "write a docs page", "the docs are wrong/confusing", "rename X across the docs", or an edit to a file under docs/. It defines the canonical concept model (bead → dependencies → ready work; formula → proto → molecule/wisp; gates; Dolt sync and federation), required terminology, the prose/emphasis/diagram conventions, the rule that generated docs are edited at their source, and the gates to run before docs work is done.

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Investigate stuck runs and execution failures by tracing Symphony and Codex logs with issue/session identifiers; use when runs stall, retry repeatedly, or fail unexpectedly.

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。

Planificación persistente basada en archivos para tareas multipaso de agentes de IA. Mantiene task_plan.md, findings.md y progress.md en disco; los hooks del ciclo de vida inyectan contexto seleccionado de planificación del proyecto. La recuperación automática solo lee los archivos de planificación del proyecto. session-catchup.py --metadata, solicitado de forma explícita, puede inspeccionar metadatos locales de sesiones del mismo proyecto; --replay puede emitir extractos limitados y enmarcados con nonce. El modo con gate opcional solo puede solicitar que el host continúe si este lo admite y nunca ejecuta comandos declarados en Markdown. El skill no tiene ninguna ruta de carga por red. Úsalo para investigación o trabajo que requiera 5 o más llamadas a herramientas.

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Perform cohort analysis on user engagement data — retention curves, feature adoption trends, and segment-level insights. Use when analyzing user retention by cohort, studying feature adoption over time, investigating churn patterns, or identifying engagement trends.

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Explain the last message, or a supplied file, link, or passage, in plain language a person follows on the first read. Use when the user invokes wtf because they did not follow something. Use ce-explain to investigate how or why code works, and ce-noslop to rewrite prose.

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Test interactive CLI/TUI applications using @microsoft/tui-test. Use when you need to test CLI tools with interactive prompts, TUI rendering, arrow key navigation, or any command that requires a TTY. Triggers include "test CLI", "test TUI", "run interactively", "automate terminal input", "simulate user input in terminal".

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 the tests, run one spec, run e2e locally or on Daytona, investigate a skipped spec. Use for executing @openwork/testkit agent-first verification.

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Audit a website, investigate its real search opportunities, and deliver a short data-backed report on the few changes most likely to grow organic traffic that converts.

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。

Triage OpenSEO production errors in Cloudflare Workers Observability — verified query recipes, counting gotchas, and a known-noise filter list applied automatically. Use when asked to review Cloudflare logs/observability, count OOMs or worker errors, compare error rates between periods, or investigate a prod error spike.

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。

Reorganize NemoClaw documentation pages, navigation, or content ownership while preserving published routes. Use for structural documentation refactors.

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Use when reviewing changed or staged code, a branch, or a PR in the Handsontable monorepo across architecture, code quality, performance, accessibility, and tests. Covers SOLID / Law of Demeter / plugin decoupling / breaking-changes policy, custom ESLint rules / JSDoc / naming / cognitive complexity, large-array and render-batching performance, WCAG 2.1 AA + keyboard navigation, and the tests a change ships (a named exercising test per new path, scoped mutation, a ticket on every weakened assertion). Trigger when asked to review changes, check a diff against Handsontable conventions, assess architectural correctness, spot performance regressions, verify accessibility, or judge whether a change's tests prove it, and as the design lens before or while implementing any core change.

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。

Investigate and review evidence-backed workflows with Screenpipe tools and shared drafts.

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Query Cloud Trace spans, filter by latency thresholds or error status, correlate distributed traces with Cloud Logging, and diagnose latency bottlenecks across Google Cloud services. Use when investigating slow requests, analyzing trace hierarchies, or resolving latency regressions. Do NOT use for querying non-GCP telemetry or database query optimization outside Cloud Trace.

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。