「tia」の検索結果

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.

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Senior Project Manager for enterprise software, SaaS, and digital transformation projects. Specializes in portfolio management, quantitative risk analysis, resource optimization, stakeholder alignment, and executive reporting. Uses advanced methodologies including EMV analysis, Monte Carlo simulation, WSJF prioritization, and multi-dimensional health scoring. Use when a user needs help with project plans, project status reports, risk assessments, resource allocation, project roadmaps, milestone tracking, team capacity planning, portfolio health reviews, program management, or executive-level project reporting — especially for enterprise-scale initiatives with multiple workstreams, complex dependencies, or multi-million dollar budgets.

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Mint a tamper-evident, post-quantum-signed receipt for a consequential agent action (deploy, delete, pay, grant-access, model decision) so it can be verified later from the certificate alone. Use when an autonomous agent takes a side-effecting action that may need to be proven later, or when satisfying EU AI Act Article 12 record-keeping. Three decisions: whether an action needs a receipt, minting it, verifying it. Signing is delegated to the open-source OpenAgentOntology package. Not after-the-fact log analysis; not a hosted notary; not a legal opinion.

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Makes AI-generated content sound genuinely human — not just cleaned up, but alive. Use when content feels robotic, uses too many AI clichés, lacks personality, or reads like it was written by committee. Triggers: 'this sounds like AI', 'make it more human', 'add personality', 'it feels generic', 'sounds robotic', 'fix AI writing', 'inject our voice'. NOT for initial content creation (use content-production). NOT for SEO optimization (use content-production Mode 3).

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ML engineering skill for productionizing models, building MLOps pipelines, and integrating LLMs. Covers model deployment, feature stores, drift monitoring, RAG systems, and cost optimization. Use when the user asks about deploying ML models to production, setting up MLOps infrastructure (MLflow, Kubeflow, Kubernetes, Docker), monitoring model performance or drift, building RAG pipelines, or integrating LLM APIs with retry logic and cost controls. Focused on production and operational concerns rather than model research or initial training.

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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.

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Manage environment-variable hygiene and secrets safety across local development and production. Practical auditing, drift awareness, rotation readiness. Use when auditing .env files for committed secrets, planning a credential rotation, debugging missing-env-var production incidents, or hardening a new project against secrets leakage.

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/cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.

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Use when reviewing or rebalancing direct vs. partner-led channel economics — computing fully-loaded cost-to-serve per channel, channel ROI with cash / LTV / marginal lenses, and optimal channel mix subject to constraints. For Head of Commercial, RevOps, and VP Sales doing quarterly channel review when pipeline is mixed (e.g., 60% direct + 40% partner-led) and nobody actually knows which channel makes money after CAC, support load, partner discount, deal-velocity differences, retention differential, and overhead allocation are all loaded in. Outputs cost to serve, channel ROI verdicts (DOUBLE-DOWN / MAINTAIN / DEFUND / EXIT), a sensitivity-tested channel-mix recommendation, and the diminishing-returns inflection (e.g., 'which channel actually makes money — direct or partner?').

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M&A strategy for acquiring companies or being acquired. Due diligence, valuation, integration, and deal structure. Use when evaluating acquisitions, preparing for acquisition, M&A due diligence, integration planning, or deal negotiation.

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Use when a startup is approached by a prospective partner and someone has to decide should we sign this partner, at what partner tier (referral / reseller / OEM / SI-consulting / strategic alliance), with what joint GTM commitment, and at what revshare. Classifies partner tier from independent-demand evidence vs. preferential-terms hunting, designs a 90-day joint GTM plan, models revshare against direct-sale margin, and surfaces kill criteria for unwinding under-performing partnerships. For Head of Partnerships, Head of BD, and Founder-CEOs doing reseller agreement, OEM deal, or strategic alliance review — not technical sale enablement, not channel cost economics, not M&A.

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Phase 4 of building a Claude Managed Agent — make it run without you. Turn a graded agent into a recurring scheduled deployment (POSIX-cron), an event-driven curl trigger, or confirmed on-demand use, then finalize the versioned roadmap. Use when the user says "run it every morning", "put it on a schedule", "nightly", "weekly", "automate this", "make it recurring", or when the orchestrator routes phase=run-without-you. deployment_builder.py builds the POST /v1/deployments payload (initial_events must include user.message; optionally nests a user.define_outcome so each firing self-grades); cron_validator.py validates the 5-field cron + IANA timezone and prints the wall-clock DST note; next_directions_writer.py writes NEXT-DIRECTIONS.md. No tool makes API calls — the deployment is created via BYOK curl. Distinct from grade-iterate (the in-session loop) and wrap-up (closeout).

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Founder onboarding interview that captures company context across 7 dimensions. Invoke with /cs:setup for initial interview or /cs:update for quarterly refresh. Generates ~/.claude/company-context.md used by all C-suite advisor skills. Use when setting up the C-suite advisors for the first time, or when company context is missing or more than 90 days old — e.g. after a fundraise or pivot.

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Discover, find, compare, audit, repair, adapt, and design repeatable AI-agent loops with explicit triggers, actions, verification, stopping conditions, guardrails, and handoffs. Use when a user asks to analyze a codebase for potential loops, mine coding-thread history for work done more than once, turn repeated engineering work into a loop, find or recommend a published loop, create a recurring agent workflow or automation cadence, turn an outcome into a bounded copy-ready loop, or review an existing loop for weak checks, unsafe authority, unbounded repetition, stale state, or unclear stopping behavior.

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Review agent-written changes before merge, after substantial edits, or when re-reviewing a repair. Use the adversarial protocol for high-risk changes or an explicitly requested deep review.

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Draft a detailed Non-Disclosure Agreement between two parties covering information types, jurisdiction, and clauses needing legal review. Use when creating confidentiality agreements or preparing an NDA for a partnership.

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Transform an output-focused roadmap into an outcome-focused one that communicates strategic intent. Rewrites initiatives as outcome statements reflecting user and business impacts. Use when shifting to outcome roadmaps, making a roadmap more strategic, or rewriting feature lists as outcomes.

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Identify 3-5 potential customer segments with demographics, JTBD, and product fit analysis. Use when exploring market segments, identifying target audiences, evaluating new markets, or learning how to segment a market.

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。

AI image generation with OpenAI GPT Image 2.5, Azure OpenAI, Google, OpenRouter, DashScope, Z.AI GLM-Image, MiniMax, Jimeng, Seedream, Replicate and Agnes APIs. Supports text-to-image, reference images, aspect ratios, and batch generation from saved prompt files. Sequential by default; use batch parallel generation when the user already has multiple prompts or wants stable multi-image throughput. Use when user asks to generate, create, or draw images.

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Structured bug report from a description, or analyze code for potential bugs. Reproduction steps, severity.

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Connect to Pascal and use its MCP tools to create, inspect, edit, validate, save, or hand off editable 3D building scenes. Use this skill whenever a user asks an agent to work in Pascal, make a room or building model, inspect a Pascal project, perform spatial edits, connect Pascal MCP, or return a verified Pascal editor link. It also governs safe local, existing-account, and explicitly authorized autonomous setup.

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Assess whether furniture fits in a measured Pascal room or layout. Use this skill for sofa, table, bed, cabinet, appliance, staging, placement, collision, clearance, or rotated-footprint questions. Produce a tool-backed spatial report that distinguishes footprint fit from unsupported height, door-swing, assembly, and delivery-route claims, and return insufficient evidence when dimensions or scale are missing.

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Remove multi-vendor AI provenance marks: invisible Unicode (Layer A), statistical text watermarks via rewrite (Layer B, always offer), and C2PA/EXIF/XMP/container metadata on PNG/JPEG/WebP/SVG/PDF/DOCX/ODT/HTML/MD/TEX. Covers Claude, Gemini/SynthID-class, OpenAI provenance, and open-LLM sampling marks. Use when the user asks to strip watermarks, remove C2PA/Content Credentials, clean AI metadata, remove invisible Unicode, anti-detect clean AI output, or runs /remove-ai-marks (aliases: /remove-claude-marks).

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Daytona seeded cloud demo, demo credentials, Acme Robotics seed. Use when the user asks to spin up, keep running, seed, or prepare an OpenWork Cloud/Den Daytona demo instance.

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。